StemCell Therapy

Location, location, location. A mantra in real estate and an unfortunate reality for proper access to health care.

In Los Angeles County, those who live in low-income communities are three times more likely to die from COVID-19 than those in wealthier areas. People of color are also disproportionately affected. Black people make up 9% of the Countys population, yet account for a staggering 15% of coronavirus-related deaths.

Regardless, LAs wealthier zip codes have reported significantly higher cases. This is not because such areas are at a higher risk; instead, the numbers are a result of significantly lower rates of testing in lower-income neighborhoods.

Just two weeks ago, Mayor Eric Garcetti expanded free COVID-19 testing to all LA County residents. However, expanding testing is not the same thing as providing equal access to it.

People from underserved communities are more likely to die from coronavirus, due to existing disparities in access to health care and a continued lack of proper prevention and treatment. The county must do more to adequately expand testing to its most vulnerable populations and UCLA can be a part of those efforts. From increasing communication about available resources to easing restrictions on access to testing, LA County and UCLA Health can help by improving testing efforts in the most marginalized neighborhoods.

Coronavirus-related death rates in neighborhoods such as East Hollywood, Pico-Union and Westlake are four times higher than the national average. These are the same areas where more than one-third of housing is overcrowded.

Timothy Brewer, a professor of epidemiology at the UCLA Fielding School of Public Health and Medicine, said there are big differences in the healthcare statistics between areas like West and South LA.

In areas where there are more African Americans in particular, those areas tend to be more crowded they tend to be poorer, Brewer said. They tend to have fewer health care facilities, and the health care facilities tend to be of lesser quality than in high-income areas.

Unfortunately, certain populations are at an extremely high risk simply by virtue of their zip code.

Systemic solutions are necessary to address these disparities, but in the mean time, proper testing and prevention is the least that LA County can provide. One way is to make sure that hospitals and clinics in low-income areas are properly staffed and have adequate resources. Its also important that these communities continue to get proper and updated information.

And UCLA has the resources to help. In early April, UCLA Health initiated testing for all incoming surgical and procedural patients, as well as ER admissions. UCLA can work with clinics in lower-income areas to launch expanded efforts.

Populations that have historically had little to no access to proper health care are just as susceptible to catching the virus, if not more. California Governor Gavin Newsom estimates that 60,000 people experiencing homelessness will become infected. In a county with the second highest rate of unsheltered individuals, these populations might not have access to food or shelter, let alone proper medical care.

These things that create pollutants tend to be much more common in people of color communities and poor communities, said Nina Harawa, a professor-in-residence with the David Geffen School of Medicine at UCLA. Literally the bodies of people in those communities are predisposed to have poor outcomes related to (COVID-19).

In California, Latinos and African Americans are exposed to 40% more pollution than white people making them more susceptible to coronavirus-related complications.

As a massive health care provider with offices spread across the city, UCLA Health can work with LA county to ensure that these populations get the information they need when it comes to accessible testing options and preventative measures.

Furthermore, undocumented workers, many of whom are working essential jobs and are at a greater risk, have no access to employment benefits or paid sick leave, despite being underpaid. They, along with mixed-status families such as DACA recipients or those with immigrant spouses, also wont get access to the stimulus check provided by the CARES Act.

And the Families First Coronavirus Response Act, which covers testing for all uninsured workers, excludes those who are undocumented regardless of the fact that they pay taxes.

And the legacy of the countrys improper treatment of undocumented individuals may heighten fears of deportation if they try to access medical care. ICE agents made arrests on the first day of Californias official lockdown.

They made it seem like you can come get it, you can come get the test, regardless of your immigration status, but (theyre) not thinking about how undocumented folks may still be hesitant and may not trust what they are saying, said Daniela Rodriguez, a fourth-year sociology student.

One major deterrent is the current identification requirement for an individual to receive testing. And while LA County has promised not to use identification for purposes of law enforcement, loosening ID requirements could greatly increase accessibility for low-income and marginalized communities.

Undocumented populations should not have to choose between their health and physical safety. It is vital that the county keeps an open line of communication with the undocumented community, so they can receive the correct information and proper testing.

Granted, LA County has already greatly expanded its testing capacity. However, this is just the tip of the iceberg. With the help of institutions like UCLA Health, the county must now make sure that testing is not just equally available, but equitably delivered. Because although the expansion towards universal testing is expensive, there is no other alternative.

Anyone, regardless of socioeconomic status, race or citizenship can become sick and spread the virus. Selectively ignoring already marginalized populations on the grounds of arbitrary social classifications will only prolong the virus reign and cause more avoidable deaths.

The virus does not discriminate and we cannot afford to either.

Read more:
Universal access is not the same as equitable access when it comes to COVID-19 tests - Daily Bruin

Development of PrEP for COVID-19 Could Allow Country to Open Safely Before a Vaccine Is Available

Development of PrEP for COVID-19 is likely possible in a shorter period of time than a vaccine. Although there are no drugs approved yet for treatment or prevention of COVID-19, expert opinions and computer modeling analysis have been able to identify a set of compounds, both small molecules and biological macromolecules, that could stop severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) from replicating in the body.1

PrEP has already been established as an effective medicine that revolutionized the fight against HIV. Since a vaccine for HIV has not yet been developed after decades of research, PrEP has been able to act as a preventative measure for those vulnerable to the disease.1 As a preventative measure, PrEP has been able to reduce vulnerable populations chance of infection by over 99%.2

Our experience with HIV shows that we cannot pin all our hopes on the development of a vaccine, no matter how optimistic we may be, said James Krellenstein, a co-founder of PrEP4All and member of the COVID-19 Working Group New York, in a press release. Development of PrEP for COVID-19 has the potential to be a major breakthrough until a vaccine is available. But research efforts will fail to deliver unless we take a dramatically different approach.2

Currently, scientists have found that some of the molecules that could block the replication of SARS-CoV-2 are already FDA-approved drugs. However, the United States has not been able to coordinate the necessary processes that would effectively evaluate the antiviral potency of these compounds in vitro. This has resulted in a limited number of them having been tested to prove their efficacy in preventing COVID-19.1

In its report, the PrEP4All Collaboration detailed 3 recommendations to facilitate a centrally coordinated process created by the US National Institutes of Health (NIH), along with industry and international partners, that would support the development of PrEP for COVID-19 prevention1:

PrEP4All has done the world a great service, said Gregg Gonsalves, assistant professor of Epidemiology at the Yale School of Public Health, in a press release. Using antiviral drugs to prevent SARS-CoV2 transmission, just as we use them to prevent HIV, opens up another way to bring this pandemic to an end. Unfortunately, what PrEP4All exposes is an effort just getting off the ground, with no coordination and leadership of key tasks like high throughput screening and prioritization of clinical trials. NIH, FDA, WHO should heedPrEP4Alls recommendations to get this effort on track and scaled-up.2

From prior experience with pandemics such as HIV, according to the report, it has been established that the most efficient method of advancing results is by creating a coordinated process between institutions such as the NIH and WHO, as well as academic and industry partners. Such a process can result in clearer directions regarding basic science and clinical care for a disease.1

In the past, PrEP has been highly effective at fighting pandemics that devastated global populations in a way that seemed uncontrollable. Today, no one knows with certainty the method that will effectively control COVID-19, but it has become necessary to find the most efficient way possible.1

We owe it to the world to explore every possible option in controlling this pandemic, said Krellenstein in a press release. PrEP could be a game-changer for the COVID-19 response and save countless lives, especially among the most vulnerable populations. But that will not happen unless we better coordinate our efforts and urgently prioritize research.2

REFERENCES

See the article here:
Development of PrEP for COVID-19 Could Allow Country to Open Safely Before a Vaccine Is Available - Pharmacy Times

BusinessEvolving health research could catalyse demand for high-end office space in Scotlands cities from the burgeoning life sciences sector, according to Knight Frank.

Tuesday, 12th May 2020, 4:45 pm

The UK Life Sciences report from the property consultancy which has offices in Edinburgh, Aberdeen, Glasgow and Melrose has found that growing collaboration between companies in the industry and the wider tech sector, plus more computational science, will cause seismic shifts in the industrys property requirements.

As medical technology, biopharmaceutical, and digital health companies become more interdependent, property will need to reflect their growing need to cluster in new locations, according to the report. It also highlighted the 750 million expansion plans at Edinburghs BioQuarter and the establishment of the Medicines Manufacturing Centre in Renfrewshire as examples of the trend already taking hold in Scotland.

Knight Frank also said Edinburgh and Glasgow were among the top UK locations for investment in digital health, attracting 30m and 10.5m respectively.Scottish Development International says there are more than 750 life sciences organisations in Scotland, with the sector adding 2.4 billion to the economy, on track to reach turnover of 8bn by 2025.

Lee Elliott, Knight Franks global head of occupier research, said: Covid-19 has brought the growing importance of life science and health research companies to the fore. The needs of the NHS, and other health services, will likely cause an acceleration in the convergence of technology and life sciences, particularly around digital diagnostics and preventative medicine.

The restructuring of life sciences companies will bring a new wave of demand from the sector, particularly in Scotland where [small and medium-sized enterprises] make up the majority of the industry.

Indeed, landlords that are able to provide flexible, cost-effective space to accommodate the rapid growth these companies can achieve and help them track their investment will be well-positioned. So too will facilities that are future-proof and capable of manufacturing advanced therapeutics.

Occupier services partner Simon Capaldi said: The shift towards more computational [research and development] will see an increase in the need for more conventional office space in city-centre locations. It is perhaps no surprise that were seeing more demand from the sector in Edinburgh, which offers a deep pool of data science talent.

Tech, more broadly, has emerged over the past five years or so as a significant source of activity in Edinburghs office market, accounting for around one-third of city centre take-up.

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Evolution of life sciences to spur need for high-end office space in Scots cities - The Scotsman

Tokyo May 14, 2020 (Thomson StreetEvents) -- Edited Transcript of Eisai Co Ltd earnings conference call or presentation Wednesday, May 13, 2020 at 7:30:00am GMT

Eisai Co., Ltd. - CEO, Representative Corporate Officer & Director

Eisai Co., Ltd. - Senior VP & President of Neurology Business Group

Eisai Co., Ltd. - VP and Chief Medicine Creation Officer & Chief Discovery Officer of Oncology Business Group

Daiwa Securities Co. Ltd., Research Division - Research Analyst

It's now time. We would like to begin financial results presentation on fiscal 2019 results. Because of COVID-19 infection situation, today we are live distributing -- streamcasting the financial results presentation.

I would now like to introduce the presenter today, Representative Director and CEO, Mr. Haruo Naito. Without further ado, I would like to -- I'll give the microphone to Mr. Naito.

Haruo Naito, Eisai Co., Ltd. - CEO, Representative Corporate Officer & Director [2]

Naito speaking. Now I would like to give you a presentation on the financial results for fiscal year 2019. Please look at the slide.

Given the current circumstances surrounding COVID-19 pandemic, we are a pharmaceutical company. Therefore, we believe that there are many roles that we should play, out of which, I think, what is most important is described on this page, which is stable supply of our products. Needless to say, each pharmaceutical product is leading to quality of life or lives of patients. Therefore, these are all life-related products. Therefore, the discontinuation of supply is not allowed.

On this slide, we are globally rolling out manufacturing at 9 sites over the world. On the right-hand side in table at each manufacturing site, the state of emergency issuance is different among different manufacturing sites. But currently, at all 9 sites, operation is smoothly ongoing. Therefore, stable supply of our products have been secured.

To maintain stable supply, as we have described at the bottom of this slide, we needed to have sufficient supply of raw materials, API or intermediates or packaging materials. These have to be kept in ample stock. To continue our manufacturing activities, such BCP, business continuity plan, is necessary. Currently, for our main products, on the average, we have ample stock of final products amounting to 4 months to 5 months of stock level.

Needless to say, another important point is at manufacturing sites, of course, we have employees who are operating the plant. We needed to secure the safety of them. We have manual -- internal manual for COVID-19 is utilized in order to implement, in fact, rigorous infection control measures to secure safety of employees. Another role to be played by us is to develop treatments and vaccines for COVID-19.

From that perspective, today, first of all, we'd like to share with you the possibility of eritoran, E5564. Eritoran, as you see at the footnote #1, which is a structural analog of lipid A, which is an activator of endotoxin of bacteria, you can see chemical structure scheme of this compound for the sugar chain. And this was a treatment which was in-house synthesized at Eisai Research Institute of Boston with an aim to get approval of this compound for indication of severe sepsis we conducted until up to Phase III trial. But in 2011, this development of eritoran was discontinued.

E5564, or eritoran, will be studied in hospitalized patients who tested positive with COVID-19 and have worsening symptoms. On the right-hand side, mechanism of action and schema are described. The target of eritoran is found at upstream of cytokine gene expression signaling. The target is TLR4. So this is a TLR4 antagonist. At the very upstream of this cytokine gene expression signaling will be inhibited. Therefore, downstream IL-6, TNF-alpha, IL-1 beta, various cytokines production will be inhibited. So eritoran is going to be tested for indication for certain groups of patients who tested positive with COVID-19.

In the lower bottom left corner, you will see the description of how we are working on this project. In the U.S., there is an international network called REMAP-CAP-COVID for repurposing of drugs. Various multiple drugs are being tested within this framework, where we have participated to explore the possibility of eritoran. Starting from June 2020, global randomized, controlled study will be initiated at domestic investigational sites. In order to prepare such sites, we are making necessary coordination. These investigational drugs are being under preparation with good quality and about 400 subjects to be enrolled in this randomized, controlled study. If everything goes well, at the end of -- around the end of this year, we'll be able to get the result out of the study and -- although the second wave and third wave of infection are anticipated, but there will be possibility to address those second and third waves of infection.

Through countermeasures against NTD, neglected tropical diseases, we have been engaged with Bill & Melinda Gates Foundation for many years. In relation to that, the Gates Foundation is taking a central role in the development of vaccines for COVID-19. As you can see in the bottom left corner, an immunologic adjuvant, E6020, which is already used in practical use, this was internally developed and discovered at Eisai Research Institute of Boston, which we may pursue the possibility as a vaccine. And The Scripps Research Institute is leading the initiative called pandemic response library, where Eisai's very unique natural products compound library has been already provided as regards to the development of treatment.

On the right-hand side, what has been already licensed out to Roivant Sciences, which is gimsilumab, which is a monoclonal antibody in Pennsylvania, Exton, former Morphotek site, has originated this antibody, which is anti-GM-CSF monoclonal antibody. For ARDS, or acute respiratory distress syndrome, Roivant Sciences has initiated trial. Utilizing our site at Exton in the U.S., we are providing API for this investigational agent.

Supporting stakeholders. That is described on this page. In Japan, under the hhc concept, we are collaborating with various groups and associations and organizations so far, for example, at the top, with local governments or medical associations. In total, there are about 167 associations with whom we have formed the partnership agreement for dementia. The second bullet shows the 4 groups of Living Labs. And the patient support groups and patient family advocacy groups over 100 groups as such in the area of dementia, cancer, epilepsy and sleep disorder. With 300 groups in Japan, we have prepared masks or relief goods and providing support goods to these groups. In the U.S., Europe, China, Asia and Africa, we are providing funding, for example, to provide PPE or providing support for the frontline health care professionals. In China, we are -- we have donated donation contribution to Wuhan Charity Federation in China.

Given these initiatives, now we would like to present to you the summary of the consolidated statement of income for fiscal year 2019. Please look at the right-hand side. The characteristics of these results are described in the headline. Operating profit was JPY 125.5 billion and profit for the year was JPY 122.5 billion. The profit for the year attributable to owners of the parent is JPY 121.8 billion, ROE is 18.6%, all of which have been the record-high numbers. In the past, for fiscal year 2010, operating profit reached JPY 113.1 billion or ROE reached 16.4%. But all these numbers exceeded that number in fiscal year 2010.

Revenue was JPY 695.6 billion, up 8% year-on-year, which will be explained in details later. This was driven by global brands, our proprietary brand drove this growth. And the cost of sales due to the mix improvement, given the growth of our in-house developed product, cost of sales ratio in the sales improved by 3.4 percentage points. Gross profit grew by double-digit rate. And R&D expenses were 97% of the previous year on this statement of income. However, including partners' reimbursement, R&D expenses were JPY 203.7 billion, which was up 6% from the previous year. We are one of the most proactive pharmaceutical companies in terms of investment in R&D among global peers.

SG&A expenses. Given the expansion of the business in the previous year, the SG&A expenses grew 12% year-on-year due to the expansion of the shared profits with partners. And operating profit was up 46% year-on-year to reach JPY 125.5 billion and profit for the year was 84% increase from the previous year to JPY 122.5 billion. At the very bottom of this page, net DER, minus 0.29 in terms of financial robustness. Therefore, net cash position was secured. The debt-free management has been maintained. In the meantime, free cash was exceeding the JPY 60 billion, therefore exceeding the amount necessary for paying dividend. Ratio of equity attributable to owners of the parent, or equity ratio, is -- was 63.8%. Given any circumstances, we can say that we have very robust financial structure, which would not be affected by any circumstances, I would say.

Here is the breakdown of changes in revenue. On this graph, as you see, the biggest factor for increasing the revenue was expansion of global brands. There was an increment by JPY 53.2 billion. And what has been obtained from the business in the previous year, that is to say, milestone payments, were recognized, increasing the revenue by JPY 10.6 billion. Given the success the business recorded in the previous year, that was the main driver for the increase in revenue this year under review.

Regarding the LENVIMA-related payments, all milestones -- preset milestones were cleared. Therefore, there was milestone payments in the amount of JPY 10.6 billion. And given the transfer right for the -- transfer of the shares of the Elmed Eisai, there was a negative factor and transfer rights for tazemetostat and the milestone payments were recognized. Therefore, there was an increase by JPY 14.1 billion, an increment in total was JPY 52.8 billion year-on-year to reach JPY 695.6 billion.

Next, breakdown of operating profit migration. The factors contributing to the changes were almost similar to what we saw with revenue and increase of shared profit of LENVIMA paid by Eisai recorded minus JPY 25.5 billion. This was all due to the expansion of LENVIMA business. Therefore, shared profit paid to partner was increased. Therefore, we believe that this is a proactive increase in the expenses. And the operating profit was increased by JPY 39.3 billion year-on-year to reach JPY 125.5 billion, which was a record-high.

On the right-hand side, you can see the R&D expenses. Please look at the column for FY 2019, JPY 140.1 billion, which was recorded on the P&L. Adding JPY 63.5 billion as the reimbursement from partners, that total JPY 203.7 billion was the actual spending in R&D activities, which accounts for about 29% of the revenue compared to the previous year, which was up 6% from a year earlier.

Now turning to LENVIMA. For fiscal 2018, 2019 and 2020, over the 3 years, we have seen a steady and dynamic growth over the years. For the current year under review, revenue was JPY 158.0 billion, which was 41% year-on-year. In the current fiscal year, we are aiming at achieving this. On the right-hand side, Americas, for hepatocellular carcinoma and the combination therapy with KEYTRUDA for endometrial carcinoma, for these indications, developments are being ongoing. And the first-line HCC indication, we are preparing for the launch for this indication, which is currently under review in combination with KEYTRUDA.

Another important market next to Americas is China for LENVIMA as well. New patient assistance program has been introduced. And the number of patients has increased by about 60% from a year earlier. And regarding thyroid cancer indication, launch readiness is being progressed. In Japan, EMEA, Asia, Latin America, endometrial cancer and HCC, the number of countries where these indications have been approved and launched is to be expanded in order to achieve this JPY 158 billion for the year.

For LENVIMA, there have been the guidances recommending this LENVIMA use from various societies. And given this COVID-19 infection risk, oral formulation cancer agents are being recommended. For example, from ILCA, International Liver Cancer Association, issued guidelines -- guidance to recommend oral formulation. And the second one, LENVIMA used to be classified as category 2 but now recommended as category 1.

For RCC, the oral formulation cancer agent has been recommended by issued guidance. And LENVIMA, everolimus combination therapy is recommended. For endometrial carcinoma, in combination with KEYTRUDA, rather than every 3 weeks but every 6-week administration is recommended. Therefore, combination therapy of LENVIMA and KEYTRUDA has been increasingly selected. And the benefit of administration of LENVIMA's oral formulation is being enhanced, given this risk of infection.

Conversion treatment is something that I've reported on past occasions. In hepatocellular carcinoma, when tumor volume is large in patients and it is Barcelona B Classification patient, first, LENVIMA can be administered to shrink the tumor volume. And then curative treatment, such as TACE, may be utilized to achieve cancer-free status in patients. And that is conversion treatment. In Japan, which is one of the most advanced countries in hepatic cancer treatment, TACE and other curative treatment have been developed and such -- correction, conversion treatment has been developed. And the combination therapy with LENVIMA allows for such conversion treatment.

Study 307, Study 309 Phase III studies are underway for combination therapy of LENVIMA and KEYTRUDA. And as for the studies listed here, enrollment of target number of patients has been completed. For Study 307 and Study 309, close to 1,000 patients have been enrolled. And we will make sure that we will make close follow-up of patients and would like to make sure that there will not be a delay -- substantial delay in the conduct of the trials. We will work with Merck to minimize negative impact of COVID-19 by working together and by working flexibly.

I would now like to discuss the topic of neurology area. First, DAYVIGO. This is lemborexant orexin dual inhibitor. In Japan and the United States, approval conditions were all satisfied and it is now ready to go. Once again, orexin biology is shown in this slide in the upper part of the slide. One of the most prominent researchers in Japan, Dr. Yanagisawa had conducted ligand hunting for orphan GPCR. And this is known as the most successful result. Orphan GPCR HFGAN72 ligand was discovered to be orexin, as shown in the middle of the slide. And orexin is a very important substance that controls sleep and wake cycles according to Dr. Yanagisawa.

And at Tsukuba Research Institute, library was built. And as a result, we were able to obtain receptor E2006 or lemborexant. There were 2 large Phase III studies, compared to placebo and compared to zolpidem ER in older patients. In these 2 large Phase III studies, very good results were obtained in sleep latency and quality of sleep. And in 2 healthy subject studies, residual next-morning effect was observed. This is the third blue triangle, and this is reflected in the package insert in the United States. As a result of the 2 studies, in comparison to placebo, there were no meaningful differences in next-day postural stability. So sleep latency, quality of sleep and residual next-morning effects in all of these 3 areas, treatment is achieved by DAYVIGO.

We are now preparing to launch DAYVIGO. Under COVID-19 situation, information communication with the traditional method of medical representatives visiting institutions will be difficult. So as shown at the bottom of the page, we will be centering around digital-centric strategy, including web seminars, digital meetings and remote communication. Centering around digital means, we would like to launch DAYVIGO. We are preparing for launch in June timing in the United States and around July timing in Japan.

Now turning to aducanumab. Towards completion of submission, we are making good progress. In the United States, we now have open BLA and have started to submit modules of the filing. This regulatory filing process, in this process, we are making good progress in open BLA submission modules of the filing. And for that, pre-BLA meeting has been scheduled. Therefore, we expect to complete the filing in Q2 fiscal 2020. We have a very good visibility of that. And at the same time, in Japan and in Europe, we are engaging with regulators. Together with Biogen, Eisai is engaging in very strong collaboration with Biogen. And we are starting to make full-fledged preparations to deliver potentially first therapy to reduce clinical decline in Alzheimer's disease patients.

About BAN2401, final regulatory requirement, Phase III study, Clarity AD, is in the stage of enrolling patients and progress had been made so far. However, because of COVID-19 impact, the pace is slightly slowing down. However, sites in China will soon initiate enrollment and the impact may be such that additional 3 months may be required. Final readout timing is changed from Q1 fiscal 2022 that we announced previously to Q2 fiscal 2022. As for earlier phase of AD, preclinical AD, we have Phase III study AHEAD 3-45. And we are about to be ready to start the study. Home infusion at patient home or assessment to be conducted remotely, these are measures that are being encouraged by the regulators. We would like to make active utilization of these methods to mitigate the impact of COVID-19 as much as possible.

Today, regarding BAN2401, I would like to discuss 201 study, which had already been completed. This is the core study. And at the bottom of the page, the situation of OLE study is described. Of course, 201 study is parallel group comparative study. ADCOMPS is used to measure the slowing of progression of the disease. And various background biomarkers are measured. And slowing of pathophysiological progression was observed through the observation of these biomarkers. And we believe that these support for efficacy clinical symptoms.

As for OLE study, after the end of the core study for 2 years, after the end of the randomized study, there is discontinuation of about 2 years. And this is the baseline for OLE study. CDR-SB is used to assess cognitive function. Between active arm and placebo arm in the core study part, there were differences in clinical symptoms. And that difference is maintained over this discontinuation period. The gap between the 2 arms is maintained. That is what this data suggests.

On the right side, in the first bullet, this is described. When disease modifying effect was demonstrated by a drug, it is considered that suppression of cognitive decline versus placebo continues after administration of drug was continued since neuropathy is reduced. This is one of the strong data suggesting disease-modifying effect. In the middle, for your information, our key drug Aricept data is shown. On the right side, at the end -- after the end of the core study of Aricept, after 6 weeks of discontinuation, cognitive function deterioration in active arm was such that the level declined to the same level as placebo arm. And this is the difference between symptomatic relief and disease-modifying drug as we see it. And that is why I am sharing with you this information on this page.

Earlier, about second-generation -- next-generation Alzheimer's disease drug treatment, I have mentioned that we have started full-fledged effort. And one of the important efforts as a part of that is dementia platform easiit. We have registered the name easiit. easiit dementia platform is shown at the center. And this uses smartphone app. easiit core asset includes Aricept accumulation of AD treatment experiences, AD is also included. And based on external cohort and high-quality data, analysis is carried out and advice can be given as a result of utilizing data. And that is the most important core asset.

Using that -- in order to use this asset, on the left side in daily living domain, to consumers, to patients -- or from consumers, from patients, personal health record can be collected, including data on sleeping, data on walking, data on diet. And from April, to providers, sales of NOUKNOW has been started. NOUKNOW is a digital tool, which allows for convenient checking of cognitive function. And through this, personal health record can be collected. And we will be applying our AI to analyze data. As shown in the arrow on the left at the bottom, we can return the information to make a recommendation of preventive action so that people can practice such action. We would like to encourage people acquiring a habit of practicing such preventative action.

On the right side, in the medical domain, medical data is collected by various medical institutions, including blood test results and medical version of NOUKNOW, Cognigram data. Cognigram uses same algorithm to measure brain performance. Such information can also be input into easiit through medical chart, through medical version of the app. Using AI algorithm, treatment effect can be visualized and side effect detection can be assisted. Such information can be provided. And this will make easier realization of optimal treatment and will also assist in conducting efficient interviews and diagnosis by doctors. So in daily living and in medical area, data can be crafted. And they can be connected and combined on the platform of easiit.

One more thing I would like to discuss about easiit is chasms that I also discussed in the information meeting. Chasm is the gap in disease understanding or barriers that must be overcome so that preventive actions become common practice. These gaps are chasms. As noted in the footnote 2, and at the left part, it shows that total population is about 66 million. Often, smaller number of people understand the disease, 44 million. And people who have acquired common practice of preventative action is even smaller in number, and people who have a common practice of checking cognitive function is even smaller. These are the chasms. And in medical domain, on the right side -- as shown on the right side, convenient diagnostic tool, whether it is prevalent, used frequently or biomarkers usage, the number of population is even smaller.

And monitoring of administration side effect, there is even bigger chasms. In each chasms stage, easiit can be used to reduce and eliminate chasm regarding the lack of understanding of disease. People between the ages of 40 to 50, we can offer content that we develop jointly with influencers through easiit to educate people on the disease. As for the lack of convenient diagnostic tool or -- we would like to provide NOUKNOW. And regarding PET test, CSF examination, easiit can provide information about the utilization rate of these equipments in institutions and offer information of that. And easiit can also help build a network for better cooperation regionally by using easiit. As shown at the very bottom including cognitive checking, lifestyle can be improved, and smooth diagnosis and treatment of dementia can be realized more easily. That is what we would like to achieve.

This is my second from last slide. COVID-19 may bring a new order or as people often call it, new normal. We are facing COVID-19 situation, and we were made to realize that there were 2 principles: first is that human life comes first, and the second is that individual countries cannot stand-alone. If -- even if one's country is okay, if the others are not okay, that is not a good situation. And in this situation, one of the most important keyword is digital transformation. Here, digital and personal should be utilized in combination. New way of communication including easiit on the digital platform, we are able to have direct 2-way communication with many patients. And our field force sales activities can use digital in combination with in-person activities.

And in medical care delivery, it is already happening -- some changes are already happening, including online medical consultation. And remote medicine among health care professionals can be further promoted even in remote areas. In African countries, apps may be utilized to understand disease prevalence. On the right side, there is a box with the title New Logistics. I discussed a stable supply earlier. Climate change will continue to be a problem, and we do not know what we will have as next pandemic. There will be natural disasters. Market may grow or shrink. With AI, we can make forecast. In raw materials procurement to production plan, we are able to better execute this. Global enterprise resource planning should be promoted.

And as shown in the next bullet, from intermediate raw material to final product, manufacturing, more on a regional basis rather than depending on global network, may become more necessary. And new life-related policy business -- and businesses is the right bottom box. It is not only pandemic. AMR and Neglected Tropical Diseases can become a major problem and disease for the whole world. We cannot become complacent and therefore, we have to enhance problem-solving abilities in low-income populations and countries. For example, Universal Health Coverage or UHC benefit level improvement is one of the things that we have to seriously address. And in regulatory approval system, priority review system should be flexibly used in broader scope as people are discussing this issue right now.

This is the PL for the ongoing fiscal 2020. JPY 719 billion is the forecasted level of revenue, 3% up from the previous year. So we expect continuous growth in revenue. And therefore, we will be making expenditures including milestone payments. And LENVIMA, JPY 154 billion of product sales including milestone revenue. LENVIMA business alone will be achieving revenue of JPY 250 billion -- or is achieving JPY 250 billion. It has grown into a very big product. And with the mix of in-house product, we will have a better situation, and we will achieve a growth in gross profit. As for R&D expenses and SG&A expenses, the input of resources -- investment of resources, this is for the investment into the future beyond EWAY 2025 into EWAY future. BAN2401 aducanumab, these AD-related diseases, for both of these, we will have large-scale studies, and we have large-scale studies. And LENVIMA shared profit partners will be increasing. And we also have to prepare to make contribution to patients through next-generation dementia drug. And therefore, we also plan to make investments in these areas.

It is now the time to make these investments. And therefore, operating profit is forecasted to be JPY 88 billion; profit for the year, JPY 67 billion. Return on equity is 9.7%. According to the forecast, equity spread will be ensured in this fiscal year. As for dividend per share, it is noted at the bottom line at the Board meeting earlier today, year-end dividend of JPY 80 was approved. And for fiscal 2020, we expect to pay annual dividend of JPY 160.

An with this, I conclude my presentation on fiscal 2019 results. Thank you for your attention.

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Unidentified Company Representative, [3]

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Now we would like to open the floor for Q&A session. (Operator Instructions)

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Questions and Answers

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Operator [1]

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(Operator Instructions)

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Unidentified Company Representative, [2]

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(Operator Instructions) The first question is from Citigroup Securities, Mr. Yamaguchi. The floor is yours. Are you ready, Mr. Yamaguchi? Can you hear? Yes. We can hear you.

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Hidemaru Yamaguchi, Citigroup Inc, Research Division - MD & Analyst [3]

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My name is Yamaguchi, I'm from Citigroup. My first question. Well, first of all, eritoran, which I have heard after a long interval, data will become available by the end of this year and in development -- rather than development and the sales for the future. Is Eisai leading initiative of sales or this network will be leading the initiatives in future sales? Which is the case?

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Haruo Naito, Eisai Co., Ltd. - CEO, Representative Corporate Officer & Director [4]

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Naito speaking. Mr. Yamaguchi, that point is yet to be considered. Now quality of this investigational drug is being secured, and we are making utmost efforts to provide the drugs to the frontline. We are trying to speed up the clinical trial as soon as possible. That is what we are working hard. But if everything goes well and the commercial production shall be accelerated proactively, of course, we would like to see Eisai taking initiative. But when it comes to specific framework for commercialization, which, I believe, is yet to be determined.

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Hidemaru Yamaguchi, Citigroup Inc, Research Division - MD & Analyst [5]

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Understood. Second question is about aducanumab. Let me clarify one point. It's a open BLA or rolling BLA, I think that is the submission made module by module. And after completion, then review process will start. That consensus in the United States, do you think that there is a delay? Or the play BLA meeting itself, there may have been any negative impact to that process or if there have been any reshuffle of the person in-charge at FDA, I think there are certain uncertainties. And I believe it's difficult for you to make any counterargument under this situation. But from your gut feeling, what is your take once completing this process? And then do you think the development afterwards will be visible?

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Haruo Naito, Eisai Co., Ltd. - CEO, Representative Corporate Officer & Director [6]

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For this point as well, it is related to regulatory filing and the timing of getting approval all to be up to discretion of the regulatory authorities. Therefore, we are not in a position to make any comments on that. But we're thinking about the usual range if the delay is contained within that normal range or some minor hedges. I believe that those are contained to the minor ones. For the fundamental core structure of the processes, we believe that these have not been swayed by this situation at all.

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Hidemaru Yamaguchi, Citigroup Inc, Research Division - MD & Analyst [7]

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Understood. My last question is about LENVIMA LEAP study. Those [116] has been submitted after immediately. And since the inception of the study, until the filing, there have been several studies where the filing process was very speedy. Do you think that this stance approach will be continued and repeated for LEAP study?

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Unidentified Company Representative, [8]

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Thank you very much. From Oncology Business Group, Dr. Owa, who is in-charge of Science is going to respond.

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Takashi Owa, Eisai Co., Ltd. - VP and Chief Medicine Creation Officer & Chief Discovery Officer of Oncology Business Group [9]

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Dr. Owa speaking. Mr. Yamaguchi, thank you for your question. Among LEAP study, I believe that what will be designated as a breakthrough therapy in the United States. If there are any potential, we would like to pursue that process together with Merck. Of course, we are not have a preconception regarding any specific types of cancer, but the universal benefit is expected from this combination of LENVIMA and KEYTRUDA. Therefore, we believe that such breakthrough therapy designation can be utilized in order to pursue the faster track approval. That is my answer.

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Unidentified Company Representative, [10]

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We have Mr. Hashiguchi from Daiwa Securities. Mr. Hashiguchi, please.

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Kazuaki Hashiguchi, Daiwa Securities Co. Ltd., Research Division - Research Analyst [11]

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View original post here:
Edited Transcript of 4523.T earnings conference call or presentation 13-May-20 7:30am GMT - Yahoo Finance

Shuhei Nakanishi,1 Hidenori Hirukawa,1 Masashi Shimoda,1 Fuminori Tatsumi,1 Kenji Kohara,1 Atsushi Obata,1 Seizo Okauchi,1 Junpei Sanada,1 Yoshiro Fushimi,1 Akiko Mashiko,1 Tomoatsu Mune,1 Kohei Kaku,2 Hideaki Kaneto1

1Division of Diabetes, Metabolism and Endocrinology, Kawasaki Medical School, Okayama, Japan; 2Department of Internal Medicine, Kawasaki Medical School, Okayama, Japan

Correspondence: Shuhei Nakanishi Email n-shuhei@umin.net

Introduction: This study aimed to examine the association between severity of diabetic neuropathy and weight loss during hospitalization in overweight participants with type 2 diabetes.Patients and Methods: Participants of this study comprised 193 patients who were hospitalized for type 2 diabetes treatment. The participants were divided into two groups in the study, based on whether or not reduction of bodyweight was at least 3% during hospitalization. Using Cox models, the association between severity of neuropathy and effectiveness of weight loss under a controlled diet was analyzed. Autonomic neuropathy was assessed on patient admission by R-R interval, as measured in an electrocardiogram (CVRR), and sensory neuropathy was assessed using both 128-Hz tuning-fork vibration and Achilles tendon reflex (ATR).Results: The adjusted hazard ratio for weight loss of at least 3% for CVRR was 1.17 (95% confidence interval 1.07 1.28, P=0.0006) and for vibration time 1.93 (1.01 3.68, P=0.045). After dividing CVRR and vibration time into tertiles based on participant number, the adjusted hazard ratio for the high tertile of CVRR was 2.17 (1.29 3.62, P=0.003), and for the long tertile of vibration time 1.84 (1.10 3.08, P=0.02), compared with the low and short tertiles, respectively. No association was detected between ATR category and weight loss.Conclusion: Severity of diabetic neuropathy was found to be a determinant in weight loss under a caloric restriction regimen for patients with type 2 diabetes. The results of the study suggest that the peripheral nervous system is involved in responses to medical intervention for treatment for type 2 diabetes including bodyweight management.

Keywords: diabetic neuropathy, weight loss, R-R interval as measured in an electrocardiogram, type 2 diabetes

This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License.By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

Read more:
Association Between Severity of Diabetic Neuropathy and Success in Wei | DMSO - Dove Medical Press

Fact.MR has adopted multi-disciplinary approach to shed light on the evolution of the global Diabetic Neuropathy market during the historical period of 2014 2019. The study presents a deep-dive assessment of the current growth dynamics, major avenues in the estimation year of 2020, and key prospects over the forecast period 2020 2025.The Diabetic Neuropathy market study includes a thorough analysis of the overall competitive landscape and the company profiles of leading market players involved in the global Diabetic Neuropathy market. Further, the presented study offers accurate insights pertaining to the different segments of the global Diabetic Neuropathy market such as the market share, value, revenue, and how each segment is expected to fair post the COVID-19 pandemic.

The global diabetic neuropathy is anticipated to surge at a CAGR of 5.6% during the forecast period (2020-2025). Extensive rounds of primary and a comprehensive secondary research have been leveraged by the analysts at Fact.MR to arrive at various estimations and projections of the Diabetic Neuropathy market, both at global and regional levels. The analysts have used numerous industry-wide prominent business intelligence tools to consolidate facts, figures, and market data into revenue estimations and projections in theDiabetic Neuropathy market.

After reading the Diabetic Neuropathy market report, readers get insight into:

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The Diabetic Neuropathy market report offers assessment of prevailing opportunities in various regions and evaluates their shares of revenue by the end of different years of the assessment period. Key regions covered comprise:

The evaluation of the competitive landscape in the Diabetic Neuropathy market covers the profile of the following top players:

Johnson & Johnson (Janssen Global Services, LLC), Boehringer Ingelheim GmbH, NeuroMetrix, Inc., Eli Lilly and Company, GlaxoSmithKline Plc.,Lupin Limited, Astellas Pharma Inc., Pfizer, Inc., Glenmark Pharmaceuticals Ltd., Arbor Pharmaceuticals, LLC and Depomed, Inc.

To expand the understanding of opportunities in the global Diabetic Neuropathy market report looks at close quarters into the opportunities and new avenues in following key segments:

In addition to understanding the demand patterns of various Distribution Channel, the report on the Diabetic Neuropathy market also enumerates trends expected to attract investments by other various associated industries.

On the basis of Disorder types, the Diabetic Neuropathy market report offers insight into major adoption trends for the following segments:

By Treatment Type,

Peripheral Neuropathy

Drugs:

Analgesic:

Topical:

Opioid:

NSAIDs:

Antidepressants:

TCAs:

SNRIs:

SSRIs:

Anticonvulsant Drugs:

Other Drugs

Radiotherapy:

Physiotherapy

The global Diabetic Neuropathy market report offers detailed assessments and quantitative evaluations that shed light on numerous key aspects that have shaped its evolution over the historical period. In coming years, some of the key aspects that will shape the growth prospects during the forecast period are objectively covered in the study.

For More Detailed Information about Methodology @https://www.factmr.com/connectus/sample?flag=RM&rep_id=4698

Some important questions that the Diabetic Neuropathy market report tries to answer exhaustively are:

About Fact.MR

Fact.MR is a fast-growing market research firm that offers the most comprehensive suite of syndicated and customized market research reports. We believe transformative intelligence can educate and inspire businesses to make smarter decisions. We know the limitations of the one-size-fits-all approach; thats why we publish multi-industry global, regional, and country-specific research reports.

Media Release:https://www.factmr.com/media-release/1445/global-diabetic-neuropathy-market

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Diabetic Neuropathy Market Demand Surges Owing to Increasing Production Associated With Covid-19, Concludes Fact.MR - The Cloud Tribune

Krenitsky Pharmaceuticals Inc

Moreover, the Chemotherapy Induced Peripheral Neuropathy Treatment report offers a detailed analysis of the competitive landscape in terms of regions and the major service providers are also highlighted along with attributes of the market overview, business strategies, financials, developments pertaining as well as the product portfolio of the Chemotherapy Induced Peripheral Neuropathy Treatment market. Likewise, this report comprises significant data about market segmentation on the basis of type, application, and regional landscape. The Chemotherapy Induced Peripheral Neuropathy Treatment market report also provides a brief analysis of the market opportunities and challenges faced by the leading service provides. This report is specially designed to know accurate market insights and market status.

By Regions:

* North America (The US, Canada, and Mexico)

* Europe (Germany, France, the UK, and Rest of the World)

* Asia Pacific (China, Japan, India, and Rest of Asia Pacific)

* Latin America (Brazil and Rest of Latin America.)

* Middle East & Africa (Saudi Arabia, the UAE, , South Africa, and Rest of Middle East & Africa)

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Table of Content

1 Introduction of Chemotherapy Induced Peripheral Neuropathy Treatment Market

1.1 Overview of the Market1.2 Scope of Report1.3 Assumptions

2 Executive Summary

3 Research Methodology

3.1 Data Mining3.2 Validation3.3 Primary Interviews3.4 List of Data Sources

4 Chemotherapy Induced Peripheral Neuropathy Treatment Market Outlook

4.1 Overview4.2 Market Dynamics4.2.1 Drivers4.2.2 Restraints4.2.3 Opportunities4.3 Porters Five Force Model4.4 Value Chain Analysis

5 Chemotherapy Induced Peripheral Neuropathy Treatment Market, By Deployment Model

5.1 Overview

6 Chemotherapy Induced Peripheral Neuropathy Treatment Market, By Solution

6.1 Overview

7 Chemotherapy Induced Peripheral Neuropathy Treatment Market, By Vertical

7.1 Overview

8 Chemotherapy Induced Peripheral Neuropathy Treatment Market, By Geography

8.1 Overview8.2 North America8.2.1 U.S.8.2.2 Canada8.2.3 Mexico8.3 Europe8.3.1 Germany8.3.2 U.K.8.3.3 France8.3.4 Rest of Europe8.4 Asia Pacific8.4.1 China8.4.2 Japan8.4.3 India8.4.4 Rest of Asia Pacific8.5 Rest of the World8.5.1 Latin America8.5.2 Middle East

9 Chemotherapy Induced Peripheral Neuropathy Treatment Market Competitive Landscape

9.1 Overview9.2 Company Market Ranking9.3 Key Development Strategies

10 Company Profiles

10.1.1 Overview10.1.2 Financial Performance10.1.3 Product Outlook10.1.4 Key Developments

11 Appendix

11.1 Related Research

Get Complete Report

@ https://www.marketresearchintellect.com/need-customization/?rid=259478&utm_source=NYH&utm_medium=888

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Market Research Intellect provides syndicated and customized research reports to clients from various industries and organizations with the aim of delivering functional expertise. We provide reports for all industries including Energy, Technology, Manufacturing and Construction, Chemicals and Materials, Food and Beverage and more. These reports deliver an in-depth study of the market with industry analysis, market value for regions and countries and trends that are pertinent to the industry.

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Tags: Chemotherapy Induced Peripheral Neuropathy Treatment Market Size, Chemotherapy Induced Peripheral Neuropathy Treatment Market Trends, Chemotherapy Induced Peripheral Neuropathy Treatment Market Growth, Chemotherapy Induced Peripheral Neuropathy Treatment Market Forecast, Chemotherapy Induced Peripheral Neuropathy Treatment Market Analysis Sarkari result, Government Jobs, Sarkari naukri, NMK, Majhi Naukri,

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Chemotherapy Induced Peripheral Neuropathy Treatment Market Growth by Top Companies, Trends by Types and Application, Forecast to 2026 - Cole of Duty

Arbor Pharmaceuticals

Moreover, the Neuropathy Pain Treatment report offers a detailed analysis of the competitive landscape in terms of regions and the major service providers are also highlighted along with attributes of the market overview, business strategies, financials, developments pertaining as well as the product portfolio of the Neuropathy Pain Treatment market. Likewise, this report comprises significant data about market segmentation on the basis of type, application, and regional landscape. The Neuropathy Pain Treatment market report also provides a brief analysis of the market opportunities and challenges faced by the leading service provides. This report is specially designed to know accurate market insights and market status.

By Regions:

* North America (The US, Canada, and Mexico)

* Europe (Germany, France, the UK, and Rest of the World)

* Asia Pacific (China, Japan, India, and Rest of Asia Pacific)

* Latin America (Brazil and Rest of Latin America.)

* Middle East & Africa (Saudi Arabia, the UAE, , South Africa, and Rest of Middle East & Africa)

To get Incredible Discounts on this Premium Report, Click Here @ https://www.marketresearchintellect.com/ask-for-discount/?rid=275286&utm_source=NYH&utm_medium=888

Table of Content

1 Introduction of Neuropathy Pain Treatment Market

1.1 Overview of the Market1.2 Scope of Report1.3 Assumptions

2 Executive Summary

3 Research Methodology

3.1 Data Mining3.2 Validation3.3 Primary Interviews3.4 List of Data Sources

4 Neuropathy Pain Treatment Market Outlook

4.1 Overview4.2 Market Dynamics4.2.1 Drivers4.2.2 Restraints4.2.3 Opportunities4.3 Porters Five Force Model4.4 Value Chain Analysis

5 Neuropathy Pain Treatment Market, By Deployment Model

5.1 Overview

6 Neuropathy Pain Treatment Market, By Solution

6.1 Overview

7 Neuropathy Pain Treatment Market, By Vertical

7.1 Overview

8 Neuropathy Pain Treatment Market, By Geography

8.1 Overview8.2 North America8.2.1 U.S.8.2.2 Canada8.2.3 Mexico8.3 Europe8.3.1 Germany8.3.2 U.K.8.3.3 France8.3.4 Rest of Europe8.4 Asia Pacific8.4.1 China8.4.2 Japan8.4.3 India8.4.4 Rest of Asia Pacific8.5 Rest of the World8.5.1 Latin America8.5.2 Middle East

9 Neuropathy Pain Treatment Market Competitive Landscape

9.1 Overview9.2 Company Market Ranking9.3 Key Development Strategies

10 Company Profiles

10.1.1 Overview10.1.2 Financial Performance10.1.3 Product Outlook10.1.4 Key Developments

11 Appendix

11.1 Related Research

Get Complete Report

@ https://www.marketresearchintellect.com/need-customization/?rid=275286&utm_source=NYH&utm_medium=888

About Us:

Market Research Intellect provides syndicated and customized research reports to clients from various industries and organizations with the aim of delivering functional expertise. We provide reports for all industries including Energy, Technology, Manufacturing and Construction, Chemicals and Materials, Food and Beverage and more. These reports deliver an in-depth study of the market with industry analysis, market value for regions and countries and trends that are pertinent to the industry.

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Neuropathy Pain Treatment Market Growth by Top Companies, Trends by Types and Application, Forecast to 2026 - Cole of Duty

Ever seen an advertisement for something called diabetic socks, and wondered what in the world that was about? Can socks get diabetes? Can other items of clothing be diabetic? What does diabetes have to do with feet anyway?

Footcare certainly isn't the first thing that comes to mind when one thinks about diabetes, but the fact is that diabetics are at a high risk of foot injuries and infections due to the potential damage high blood sugar levels can do to the nervous and circulatory systems.

A variety of other factors can also pose a risk to diabetics and their feet.

Feet must be washed and thoroughly dried regularly to prevent fungal infections like athletes' feet from excess moisture. Washing your feet with warm, soapy water each day will help prevent bacteria buildup and infection. Applying talcum powder between toes afterward can dry out those areas and reduce the chance of athletes foot and other fungal infections.

Extreme temperatures are also a hazard. As tempting as it may be, dont put your feet up in front of your campfire. You should also wear closed shoes when walking on hot sand or pavement and always apply sunscreen to your feet when theyre exposed to the sun. If you have nerve damage in your feet, you may not notice a burn until its severe, so its best to prevent it altogether.

Cold feet can also be related to restricted blood flow, so keep them warm by sleeping with socks on in the winter and wearing warm, waterproof shoes in bad weather.

While diligent daily care is the best way to keep feet healthy, diabetic socks are a great tool to help you out.

Diabetic socks, are socks specially designed to prevent the development of foot problems among those living with diabetes. Their features are engineered to address all the aforementioned issues to help you keep your feet healthy.

These socks are usually made of a material that wicks away moisture, like that found in exercise clothing, so that the feet stay dry. Some brands even have antimicrobial features in their fabric to help prevent bacteria and fungal growth. In colder temperatures, these socks will keep your feet warm, ensuring good circulation.

These socks are also seamless, so you dont have to worry about pesky rubbing producing blisters. In someone with neuropathy or chronic high blood sugar, something as small as a blister can ultimately turn into an ulcer. Special padding in sensitive areas also helps to prevent injuries like this.

In many cases, diabetic socks have white soles. This can alert the wearer if they have any sort of foot wound because the drainage of blood or other fluid will be visible from outside the sock.

There are a variety of diabetic socks available, with different features and advantages to suit each individuals needs. Consider which are best for you or get a variety for different times of the year and different activity levels.

In general, diabetic socks serve one or more of three purposes: they keep your feet dry, they keep temperature steady, and they prevent abrasions. All will do each of these to some degree, but you can choose which to prioritize in your choices.

While most diabetic socks have some sort of moisture-wicking technology, be sure to look for this specifically if you are very active or have a physically demanding job. These materials pull moisture away from the feet to help to evaporate the sweat, reducing the risk of fungus and infections. They also help to cut down on odor.

Copper-infused socks are made with copper-infused yarn and also have antifungal properties and anti-odor protection.

Padded acrylic socks are ideal for those who exercise often because they keep feet dry and help cushion them to reduce the risk of any foot injury.

You can also find heavily padded or gel-padded socks if you are in need of this additional cushioning.

The yarns that make up your socks can also make a huge difference in the health of your feet. While most diabetic socks are made from soft yarns like wool and bamboo, you can also find those specially made to reduce friction that causes blisters.

If youre really looking to maximize the benefits of your socks, consider new smart socks, which have embedded sensors that alert you of foot temperature changes that might be signs of friction that causes blisters to form. These socks need to be replaced regularly but are a great option for those without much feeling in their feet.

Whatever type of sock you choose, be sure to change and wash them regularly and replace them at the first sign of wear and tear, as holes or pilling can themselves cause injury.

Its important to remember that while diabetic socks are a great tool for the prevention of foot problems, you should always see your doctor if youve already developed an issue.

Slow-healing wounds, unusual odor, and continuous pain in legs are all signs that something is wrong and you should check in with your doctor. Also, keep an eye out for changes in the color or shape of your feet, and ask your doctor to do a foot check-up at your next visit to make sure theyre healthy. Diligent care is the best way to prevent foot problems from developing.

Read the original:
What are Diabetic Socks and Why Might You Need Them? - The Jerusalem Post

The first installment of a documentary called Plandemic stormed through social media this week, promising viewers on its website that the film will expose the scientific and political elite who run the scam that is our global health system. The video appeared across platforms, with individual uploads each garnering hundreds of thousands of views.

But the viral video, running nearly 26 minutes, weaves a grand conspiracy theory by using a host of false and misleading claims about the novel coronavirus pandemic andits origins, vaccines, treatments for COVID-19, and more.

The video is largely an interview with Judy Mikovits, a former chronic fatigue researcher who has lobbed a number of accusations against National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci. Mikovits was an author on a controversial 2009 study linking a retrovirus to chronic fatigue syndrome that was published in the journal Science, and then retracted in late 2011 after labs were unable to replicate the results and other issues were brought to light.

That same year, in September 2011, Mikovits was fired from her position as research director at the Whittemore Peterson Institute in Nevada and arrested two months later after the institute alleged she stole a laptop, flash drives and other property with institute information. While Mikovits claims in the documentary that she was held in jail despite being charged with nothing, a criminal complaint from November 2011 shows she was charged with two felonies related to the stolen property. The charges were later dropped.

What followed was a years-long legal battle in which Whittemore won a civil judgment against Mikovits; Mikovits filed for bankruptcy; and Mikovits alleged that Whittemore defrauded the government by misusing federally funded research materials. The latter case was dismissed this year.

Mikovits recently co-authored a book with self-described anti-vaxxerKent Heckenlively, with a forward by vaccine skeptic Robert Kennedy Jr., and has spoken at events aimed at discrediting vaccines.

In the video, she claims, And they will kill millions as they already have with their vaccines. Its unclear what vaccines shes referring to, but vaccines have been credited with saving millions of lives. For instance, according to one estimate by researchers with the Centers for Disease Control and Prevention and the World Health Organization, the measles vaccine has saved more than 20 million lives across the globe from 2000 to 2016 alone.

In the sections below, we break down eight of the false, misleading and unfounded claims aired in Plandemic.

The first part of the video focuses largely on two sweeping, but unrelated, accusations against Fauci, who also has been a fixture at the White House briefings on COVID-19.

Without offering any evidence, the video claims that Fauci was part of a cover-up and that he worked with other doctors to take credit and make money on the AIDS epidemic.

Filmmaker Mikki Willis sets the tone for this section of the video, saying to Mikovits, So Anthony Fauci, the man who is heading the pandemic task force, was involved in a cover-up. Willis, a former model, has a large following on YouTube, where he has previously claimed the novel coronavirus was intentionally released.

He directed the cover-up, Mikovits says. And, in fact, everybody else was paid off, and paid off big time.

But at no point in the video does anyone explain what Fauci supposedly covered up.

We asked Mikovits in a phone interview to explain. She said it was a reference to her 2009research paperthat was laterretracted. Mikovits holds Fauci responsible and claims it was part of a cover-up on the part of the medical establishment to keep hidden her research linking a mouse retrovirus to chronic fatigue syndrome. In the years since the research was first published, Mikovits has expanded its reach, suggesting that it could apply also to prostate cancer, lymphoma, and autism.

The NIAID funded Mikovits initial research related to chronic fatigue syndrome, and, after she was fired, another researcher at Whittemore was awarded the remaining grant money. But there is no evidence that Fauci, personally, had anything to do with it. And the journal that published the paper made no mention of Fauci in its retraction. Rather, it explained it was fully retracting the paper because the results couldnt be replicated, even in the same lab, and there is evidence of poor quality control in a number of specific experiments in the Report.

As for the claim about the AIDS epidemic,that goes back much further. In the early 1980s, Mikovits was working as a technician at the National Cancer Institute. She claimsthat the lab she was in had identified the HIV virus from blood and saliva samples and prepared a paper detailing those findings that was slated for publication.

But, she says in the video, referencing one of the pioneers of AIDS research, Dr. Robert Gallo,Fauci holds up the paper for several months, while Robert Gallo writes his own paper and takes all the credit.

Mikovits could not provide the name of her labs paper or the journal that was going to publish it when we spoke to her, so we couldnt check on that. But heres what we do know about the timeline for AIDS research in the early 1980s:

1981 The Centers for Disease Control and Prevention published an article in its Morbidity and Mortality Weekly Report describing a rare lung infection in five young gay men in Los Angeles. Fauci would later recall seeing that article, saying in a 2011 interview, I remember putting the issue to the side of my desk, thinking, Wow, what a bizarre curiosity. One month later, in July, a second MMWR report came to my desk, and this time, an additional 26 men had it, again all gay, all seemingly healthy, and not only in LA, but now also in San Francisco and New York City. I remember reading it very clearly. It was the first time in my medical career I actually got goose pimples. I knew something was very wrong. It changed the direction of my career.

1982 The CDC used the term AIDS, Acquired Immune Deficiency Syndrome, for the first time.

1983 A group of French researchers identified the virus now known as HIV. Twenty-five years later, Franoise Barr-Sinoussi and Luc Montagnier were awarded the Nobel Prize for that discovery.

1984 A team led by Gallo at the National Cancer Institute published research showing that HIV causes AIDS.

Beyond the unsupported claim that Fauci who didnt become the director of NIAID until 1984 stymied early AIDS research at the National Cancer Institute, Mikovits also claims that he has profited from the epidemic.

Referring vaguely to patents, Mikovits says in the video that Fauci was working with other researchers to take credit and make money on the AIDS epidemic. Its true that Faucis name appears on at least six patents related to AIDS research. But its less clear how much he has profited from them. In 2005, the Health and Human Services Department was criticized for not disclosing how much government scientists were collecting from patent royalties. At the time, Fauci expressed concern over the potential for the appearance of a conflict of interest and said that he donated all of his royalty money to charity.

Mikovits makes a claim that numerous scientists have refuted: that the novel coronavirus was manipulated in a laboratory and is not naturally occurring.

So its very clear this virus was manipulated, these, this family of viruses was manipulated and studied in a laboratory where the animals were taken into the laboratory, she says in the video. And this is what was released, whether deliberate or not, that cannot be naturally occurring. Somebody didnt go to a market, get a bat. The virus didnt jump directly to humans. Thats not how it works. Thats accelerated viral evolution. If it was a natural occurrence, it would take it up to 800 years to occur. This occurred from SARS-1 within a decade. That is not naturally occurring.

The exact origin of the coronavirus is not known, but scientists have said the genetic features of SARS-CoV-2 indicate it was neither created in a lab nor manipulated.

Our analyses clearly show that SARS-CoV-2 is not a laboratory construct or a purposefully manipulated virus, said an article published in Nature Medicine in March. Instead, the authors said its plausible that the coronavirus originated in one of two ways: natural selection in an animal host before zoonotic transfer, which refers to the spread of disease from animals to humans, or natural selection in humans following zoonotic transfer.

The authors said the possibility of an inadvertent laboratory release of SARS-CoV-2 cannot be ruled out, but they do not believe that any type of laboratory-based scenario is plausible because they had observed all notable SARS-CoV-2 features in related coronaviruses in nature.

In a statement in April, University of Sydney professor Edward Holmes, who was involved in mapping the genome of the coronavirus that causes COVID-19, likewise said: Coronaviruses like SARS-CoV-2 are commonly found in wildlife species and frequently jump to new hosts. This is also the most likely explanation for the origin of SARS-CoV-2.

Holmes said there is unfounded speculation that a bat coronavirus named RaTG13, which was being kept at the Wuhan Institute of Virology, was the origin of the new coronavirus. But, he explained, that is not the case, for several reasons.

In summary, the abundance, diversity and evolution of coronaviruses in wildlife strongly suggests that this virus is of natural origin, Holmes said. He added that more sampling of other animals is needed to resolve the exact origins of SARS-CoV-2.

Mikovits also may give viewers a false impression when she says the novel coronavirus occurred from SARS-1, which is a different coronavirus that caused a global outbreak in 2003.

SARS-CoV, or severe acute respiratory syndrome, is similar but distinct from SARS-CoV-2. The viruses share about 79% of the same genetic make-up, but SARS-CoV-2 is even more closely related (96%) to the bat coronavirus from which Holmes has said SARS-CoV-2 wasnt derived.

Weve already written about a bogus analysis that suggested the new coronavirus could have leaked from a Chinese lab because a portion of its genome is similar to part of a viral vector that was used in previous research on SARS.

Kristian Andersen, the director of infectious disease genomics at the Scripps Research Translational Institute, told us in an email that analysis was completely wrong.

Also on the issue of the Wuhan lab, the video shows a clip claiming that $3.7 million flowed from the National Institutes of Health here in the U.S. to the Wuhan lab in China and that NIAID had already been conducting experiments with the Wuhan lab in the past in regard to coronavirus.

Thats misleading.

The project referenced, as other fact-checkers have previously reported, is actually funding from NIAID to EcoHealth Alliance, a U.S.-based nonprofit that researches emerging infectious diseases. The project was done to examine the risk of future coronavirus (CoV) emergence from wildlife using in-depth field investigations across the human-wildlife interface in China, in particular the risk posed by bats, according to a 2014 description.

NIH records show the project was awarded nearly $3.4 million altogether. Most of the funding was through a five-year grant awarded in 2014, Robert Kessler, an EcoHealth spokesman, said in an email to us. The group was renewed for a second five-year grant in 2019 and received $292,161 but NIH recently terminated the grant.

Of that money, only $600,000 (from the first grant) was given to the Wuhan Institute of Virology, Kessler said. The Wuhan lab was a collaborator that was pre-approved by NIH and the State Department, he added, and one that researchers used to conduct genetic analyses of the viruses.

In each of nearly 30 countries around the world where we work, we collaborate with local institutions, all of which are pre-approved by our federal funders, EcoHealth said in an April 28 statement about the terminated funding. Its been EcoHealth Alliances position for the past 15 years that coronaviruses present a clear and immediate threat to our safety. That seems clearer now than ever before.

The group said its research aimed to analyze the risk of coronavirus emergence and help in designing vaccines and drugs to protect us from COVID-19 and other coronavirus threats. In fact, genetic sequences of two bat coronaviruses that we discovered with this grant have been used as lab tools to test the breakthrough antiviral drug Remdesivir.

So its incorrect, and also lacks context, to claim NIAID gave $3.7 million to the Wuhan lab.

Mikovits falsely claims that if youve ever had a flu vaccine, you were injected with coronaviruses.

Shes wrong, Dr. Paul A. Offit, director of the Vaccine Education Center at Childrens Hospital of Philadelphia, told us in a phone interview. Thats not true.

This person doesnt know what she is talking about, Dr. Lee Riley, professor and chair of the Division of Infectious Disease and Vaccinology at the University of California, Berkeley School of Public Health, told us in an email, adding, I think this person is just seeking publicity.

In an interview, we asked Mikovits what support she had for the claim, and she didnt provide any. She only said that flu vaccines are cultured in chicken eggs and dog kidney cells, and those animals have coronaviruses. Its an extreme leap to then claim animal strains of coronaviruses end up in vaccines tested and approved for people. Mikovits further said she attributes the spread of the novel coronavirus worldwide at least in part to the use of the flu vaccine.

As weve explained before, coronaviruses are a diverse family of viruses, and some, such as canine coronavirus, infect animals. Those arent the same as SARS-CoV-2, the coronavirus that causes COVID-19.

As for influenza vaccines, most are made using hens eggs, Offit explained, and about 10% of vaccines in the U.S. are cell-culture vaccines, which use mammalian cells instead of eggs. Specifically, the process uses Madin-Darby Canine Kidney, or MDCK, cells.

These lines have been around for a long time, Offit said. This is a well-tested cell line that does not contain coronavirus and would never be allowed to.

On its website, the Centers for Disease Control and Prevention has more information on how egg-based and cell-based influenza vaccines are manufactured. A cell-based method that also used eggs at the beginning of the process received Food and Drug Administration approval in 2012, and a fully cell-based process got FDA approval in 2016.

The CDC notes that once vaccines are manufactured, FDA tests and approves the vaccines prior to release and shipment.

This cell-based technology has been used in other U.S. vaccines, including vaccines for rotavirus, polio, smallpox, hepatitis, rubella and chickenpox, the CDC says.

Mikovits also repeats the unsubstantiated claim that the flu vaccines increase the odds by 36% of getting COVID-19, which weve previously covered.

Experts say that there has been no study linking the flu shot to elevated risk for the novel coronavirus. The military study cited by Mikovits involved four types of seasonal coronaviruses thatcausecommon colds, not SARS-CoV-2.

More than that, the results in the study that indicate a flu-vaccinated person had an increased likelihood of testing positive for a seasonal coronavirus do not appear to be adjusted for age groups or seasons. Those factors could affect someones chances of getting a specific virus, regardless of whether or not theyve been vaccinated for the flu.

Multiple scientists have pointed out the same issue in other fact-checks, too, and have debunked the erroneous suggestion that the study looked at SARS-CoV-2.

The Military Health System told us in a statement that the study does not show or suggest that influenza vaccination predisposes in any way, the potential for infection with the more severe forms of coronavirus, such as COVID-19. MHS further said it remains essential for people to obtain the seasonal flu shot each year as it becomes available.

The video makes the unsubstantiated claim that the antimalarial drug hydroxychloroquine is the most effective medication to treat COVID-19, citing a survey of doctors.

Shortly after that, Mikovits says hydroxychloroquine is effective against these families of viruses, referring to the family of coronaviruses, such as COVID-19, but they keep it from the people.

We have covered this ground before when President Donald Trump encouraged the off-label use of chloroquineand its derivativehydroxychloroquine for treatment of COVID-19 patients. Both drugs are used to treat malaria, lupus and rheumatoid arthritis.

But there is only limited evidence that hydroxychloroquine is effective for COVID-19, and it carries potential health risks.

The National Institutes of Health says there is insufficient clinical data to recommend either for or against using chloroquine or hydroxychloroquine for the treatment of COVID-19.

Despite insufficient clinical data, the Food and Drug Administration issued an emergency use authorization, or EUA, order on March 28 that allowed for the drugs to be used as a treatment for some hospitalized COVID-19 patients.

A little less than a month later, the FDA issueda warning against using hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems. The warning came a few days after astudyfoundthat patients at Veterans Health Administration medical centers treated with hydroxychloroquine had an increased mortality risk compared with those that were not treated with the drug.

In the video, Mikovits says, The AMA was saying doctors will lose their license if they use hydroxychloroquine, the anti-malarial drug thats been on the list of essential medicine worldwide for 70 years. Dr. Fauci calls that anecdotal. Its not storytelling if we have thousands of pages of data saying its effective against these families of viruses. This is essential medicine and they keep it from the people.

Its not true that the American Medical Association told doctors they will lose their license if they use hydroxychloroquine for COVID-19. The AMA issued a statement saying it opposed purchasing excessive amounts of chloroquine or hydroxychloroquine for possible COVID-19 treatment. But it also said, Novel off-label use of FDA-approved medications is a matter for the physicians or other prescribers professional judgment.

As for hydroxychloroquines effectiveness against coronaviruses, we have written that at least two studies show that it has antiviral activity against the novel coronavirus in cells grown in the lab. But there is only anecdotal evidence that the drug works in people.

Trump cited in a tweet the results of a small clinical trial in France, but the International Society of Antimicrobial Chemotherapy, which publishes the journal in which the study appeared, later issued a statement that said the article does not meet the Societys expected standard, especially relating to the lack of better explanations of the inclusion criteria and the triage of patients to ensure patient safety.

We cover this more extensively in our story Trump Hypes Potential COVID-19 Drugs, But Evidence So Far Is Slim.

In attacking public health measures taken to address the pandemic in the U.S., Mikovits wrongly suggests that using masks could lead to people infecting themselves with their own breath. Wearing the mask literally activates your own virus, Mikovits said. Youre getting sick from your own reactivated coronavirus expressions and if it happens to be SARS-CoV-2, then youve got a big problem.

Experts were perplexed by what she meant and said the implication that simply breathing through a mask could lead to self-infection doesnt square with science.

Linsey Marr, a professor of civil and environmental engineering at Virginia Tech who studies airborne disease transmission, told us: If youre shedding (breathing out) virus, then youre already infected. Even without a mask, infected people who are shedding virus probably rebreathe some of their own viruses, but there are already billions times more viruses in your body. Hopefully, the mask is protecting other people from your exhalations.

And Lisa Brosseau, an expert on respiratory protection and infectious diseases and a certified industrial hygienist, said in an email that viruses are not activated by anything, as Mikovits suggests.

Viruses instead require living cells in order to replicate, but their viability or ability to replicate isnt affected whether someone is wearing a mask or not, said Brosseau, a former professor at the University of Illinois at Chicago. If anything, viruses in the environment can be rendered non-viable by exposure to certain temperature and relative humidity conditions.

There is nothing magical about our breath that activates or reactivates a virus, Brosseau said.

As weve previously written, while there is little research on cloth masks, the hope is that they can help prevent individuals, even those who do not feel sick, from unknowingly spreading COVID-19 to others. Brosseau said people should frequently wash cloth masks, though, and stressed that masks are not a substitute for social distancing. The CDC notesthe same.

Mikovits says in the video: In 1999, I was working in Fort Detrick and my job was to teach Ebola how to infect human cells without killing them. Ebola couldnt infect human cells until we took it in the laboratories and taught them.

Its not clear what she meant by that, and she didnt explain when we asked about her claim.

But the suggestion that Ebola, which includes six species of ebolaviruses, didnt infect people until 1999, or later, is false.

The first two species, Zaire ebolavirus and Sudan ebolavirus, were discovered after outbreaks in 1976 in Central Africa. Combined, those two viruses, which scientists believe may have come from bats or nonhuman primates (such as chimpanzees, apes, monkeys, etc.), killed about 430 people that year, according to the CDC.

Zaire ebolavirus which is also linked to the largest Ebola outbreak which began in West Africa in 2014 is said to have initially spread in 1976 through the use of contaminated needles and syringes at a hospital in the village where the first infected person was treated. And the Sudan ebolavirus is believed to have started with workers in a cotton factory.

In fact, the CDC says four of the six species of ebolavirus Zaire ebolavirus, Sudan ebolavirus, Ta Forest ebolavirus (formerly Cte dIvoire ebolavirus) and Bundibugyo ebolavirus are known to cause disease in people. And three of the four species were discovered prior to 1999.

A fifth species, Reston ebolavirus, was first discovered in 1989 in research monkeys imported into the U.S. from the Philippines. That species is known to cause disease in nonhuman primates and pigs, but not in people, the CDC says. There have been cases in which individuals developed Reston ebolavirus antibodies, but did not experience symptoms.

The sixth species, Bombali ebolavirus, was discovered in 2018 in a bat in Sierra Leone. It also is not known to infect humans.

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Jason Kingdon has been commercializing AI for over 25 years. He has a PhD from UCL Computer Science, he co-founded UCLs Intelligent Systems Lab in 1992 and pioneered one of the worlds first neural nets for live financial forecasting.

Jason is the Chairman and CEO of Blue Prism, a company that is unleashing the collaborative potential of humans and digital workers to transform the future of work, so every enterprise can exceed their business goals and drive growth with unmatched agility and speed.

Youve been involved in some form of AI for over 25 years now. What was it that attracted you to the space initially?

I became attracted to the artificial intelligence space because around the time I was in school earning my Ph.D. in intelligent systems and starting my career in research, there was a big boom in technology surrounding software with companies like Microsoft and Apple and Oracle. These organizations were using machines to solve problems people were facing on a daily basis and it was really enticing to become a part of this movement.

In 1992 you co-founded UCLs Intelligent Systems Lab. What were some of the projects that you worked on?

After co-founding UCLs Intelligent System Lab, I became founder/CEO of Searchspace, a successful UCL spinout project. We created Intelligent Transaction Monitoring Systems, which to this day are the global standard for money laundering and terrorist finance detection within the top-tier banks.

You were also responsible for introducing intelligent transaction monitoring on various exchanges such as the London Stock Exchange, and the New York Stock Exchange. Could you discuss the type of data that was being monitored and the type of AI implementation this was?

While we started Searchspace with broad ambitions for transaction monitoring, the project came to focus primarily on anti-money-laundering (AML) technology for banks and the middleware to link it to other systems. We produced an intelligent system that worked for the London Stock Exchange, the New York Stock Exchange, and others.

You also formed a private AI research lab called glass.ai. What was the mission of glass.ai?

The mission of glass.ai was and is to read and interpret vast quantities of textual data whether from websites, news, proprietary databases or other sources at scale, using AI to combine semantic analysis and resource crawling.

You then joinedBlue Prism as Executive Chairman, could you discuss what attracted you to this company?

I was drawn to Blue Prism in 2007 because of the ingenious way that theyd solved the operational inefficiencies within the banking sector where human workers perform repetitive tasks by interoperating between enterprise-wide IT systems. Traditional IT methods couldnt easily address this, as they were focusing on big ticket items, so a more agile automation solution was created by Blue Prism that could be run by non-technical business people but in a highly secure and regulated way.

What really impressed me was how theyd advanced business automation in such an elegant, light way taking the user interface seriously and repurposing it as a machine interface. Focusing on the interface meant that you can theoretically connect it to any past present or future system. The significance of this breakthrough was very clear to me especially when at Searchspace, clients always wanted extra things that involved integration with other systems.

Blue Prism solved these system interoperability challenges by pioneering robotic process automation (RPA) software that runs a pre-built, Digital Worker a software robot that automates tasks over any third-party system independently of machine APIs. Another breakthrough was that the Digital Worker uniquely used AI techniques to carry out tasks in the same way humans do but much faster and more accurately. I also saw RPA as a potential route for organizations being able to more easily test and then deploy any new transformative tech innovation.

The real light bulb moment came when I was introduced to a major UK online retailer who was an early Blue Prism RPA adopter. I was introduced to Kate an employee who ran the robots, and shed recently used them to reverse overpayments on 2,000 accounts. What amazed me was this complex activity was performed in less than 1 day, but without that robotic capability, the same activity would have taken a number of staff over three weeks to complete.

I believed that commercializing AI-powered automation in this way would have a profound effect on business and society. Blue Prism really understood and embraced this from the beginning and thats been reflected in the companys efforts every step of the way.

What has your journey with Blue Prism been like so far?

So far, it has been very exciting, fast-paced, challenging, all-encompassing and rewarding. Since investing in the business in 2007, Ive spent my time as Chairman driving our growth and vision strategy, and helping take the company public in 2016. This IPO provided the engine for growth and product development while providing the means for us to make critical investments, such as the acquisition of Thoughtonomy in 2019.

Im proud to say that over the last four years, weve gone from 60 to over 1,000 people, were selling in 170 countries to 70 commercial sectors and are approaching 1700 customers including many of the worlds biggest brands.

In fact, we recently reported achievingthe fastest revenue growthof all large UK public software companies for the fourth consecutive year in 2019.

As Chairman and CEO, Im now shaping and evolving our product roadmap that takes RPAinto the AI era while working tirelessly to promote the vision of a Digital Workforce for every enterprise. In my vision for the future, businesses will have a new organizational structure one-third human employees, one-third Digital Workers, and one-third core IT. Human workers will continue to provide strategy and creative thinking, Digital Workers will execute on business processes, and core IT will provide the underlying technology infrastructure and data storage.

With Thoughtonomy, in addition to its cloud capabilities, the acquisition is providing access to analytics that enable better ways of looking at the Digital Workers, seeing how they are deployed, seeing all the activities taking place. We are also working on ways to enhance the way Digital Workers and humans interact. The interplay between humans and Digital Workers is absolutely part and parcel of the enterprise vision and a Digital Workforce in every organization.

In the new operating environment recently created by COVID-19, our Digital Workers are arguably more important than ever in driving organizational adaptation and resilience. We are working to meet this demand by helping organizations to maintain business continuity and resilience to alleviate operational challenges through intelligent automation.

Blue Prism helps companies deliver robotic process automation (RPA) with a step-by-step methodology for a smooth implementation. For people not familiar with RPA, could you discuss what it is and how it can benefit different enterprises?

Our RPA technology runs an AI-powered, Digital Workforce; a self-organizing, multi-tasking, intelligent, processing resource thats trained and run by business to safely automate evermore complex, end-to-end, business activities faster and more accurately than humans. This enables our customers to exceed their business goals and drive meaningful growth, resilience and continuity with unmatched speed and agility.

To deliver results fast, Digital Workers arrive already pre-built and can simply be trained by business people without coding skills and put to work using a centralized operating system to draw, create and publish process automations. Digital Workers amplify gains by compounding how work is carried out as published automations and all related innovations are centralized to be shared, reused and improved by the whole business.

Digital Workers are managed by humans with our industry-leading, Robotic Operating Model delivery methodology that provides the most effective, proven way to; business-align, organize, identify, design, test, deploy and sustain process automations at scale so business-led, IT approved, enterprise-wide transformation is achieved. All Digital Workers are easy to deploy, manage, upgrade, scale and can be used by remote-working employees due to an availability on-premises, in the cloud, hybrid, or as an integrated SaaS solution.

We are helping organizations operating in all sectors achieve 6 areas of proven value delivery:

Could you discuss why you believe the Blue Prism solution is superior to competing RPA product offerings?

Our Digital Workers achieve greater transformational potential across the enterprise than other competitor robots as they possess business-led, no-code, centralized, design principles.

Our Digital Workers are also equipped with what we believe are the following totally unique attributes:

Competitive RPA offerings favor a form of digital assistant for a single person to perform all kinds of time-saving activity. And thats great, but its not taking full advantage of RPA in an enterprise environment. This is because robots that are distributed across individuals desktops and used in individual, soiled, contexts may help the individual but wont enable any benefits to be scaled and experienced by the whole enterprise.

Another major consideration is that due to a growing scarcity of software development skills, those robots that require any coding will ultimately suffer the same high costs and deployment delays as traditional IT projects.

What is the Blue Prism Digital Exchange (DX)?

The Blue Prism Digital Exchange (DX) is a ground-breaking intelligent automation app store and online community that offers an open ecosystem for intelligent automation capabilities. The Blue Prism DX offers connections to all transformative technologies which are simply dragged and dropped into process flows to be used for the continual testing, advancing, sharing and deployment of new automated innovations. This could be new AI, machine learning, chatbot and other cognitive capabilities. Blue Prisms DX is significant as its now driving those AI capabilities into the wider enterprise which is something that organizations would previously never have been able to experience.

Thank you for the interview. Anyone who wishes to learn more should visit Blue Prism.

Original post:
Robert Youngjohns, Chairman of the Board, ABBYY - Interview Series - Unite.AI

DGAP-News: Vita 34 AG / Key word(s): Quarter Results14.05.2020 / 07:30 The issuer is solely responsible for the content of this announcement.

Business development of Vita 34 stable and unaffected by COVID-19 development so far

Leipzig, 14 May 2020 - Vita 34 AG (ISIN: DE000A0BL849; WKN: A0BL84), one of the largest cell banks in Europe, has made a stable start to the new 2020 financial year. Revenues in the first quarter remained almost at the previous year's level. In the second quarter, the current order intake also shows a linear sales development so far. To secure the supply of production-relevant preliminary products, sufficient precautions have been taken to prevent negative effects on process stability in connection with the COVID-19 pandemic.

At EUR 4.7 million, revenues in the first quarter were 2.3 percent below the previous year (Q1 2019: EUR 4.8 million). As a result of the targeted increase in marketing and sales expenses by approximately nine percent to EUR 1.4 million compared to the prior-year period (Q1 2019: EUR 1.3 million), earnings before interest, taxes, depreciation and amortization (EBITDA) were down 9.9 percent to EUR 1.2 million (Q1 2019: EUR 1.3 million). "In the past financial year we analyzed how to deploy our budgets in an even more targeted manner in order to achieve organic growth in our core market," explains Dr. Wolfgang Knirsch, CEO of Vita 34 AG. "Accordingly, we have increased our marketing and sales expenses in certain areas in order to accelerate our organic growth and further consolidate our leading market position."

The company's liquidity situation remains very positive. At EUR 9.1 million, cash and cash equivalents were at the same level as at the end of 2019 (31.12.2019: EUR 9.1 million). "The changed environment, which came as a surprise to us with the COVID-19 pandemic in the first quarter of 2020, required extraordinary efforts at all levels. Due to the still difficult assessable range of the effects of the pandemic, the focus of the measures was on maintaining core processes. From today's perspective, we have achieved this. It is therefore all the more pleasing that despite the expansion of working capital that was necessary in certain areas, liquidity was maintained at a high level," explains Falk Neukirch, CFO of Vita 34 AG.

The key figures for business development in the first quarter of 2020 are as follows:

Since the beginning of May, the company has also been able to return to addressing the relevant target groups personally in the market. "It goes without saying that we are exercising the utmost caution in dealing with this special situation," explains CFO Falk Neukirch. "As things stand at present, however, we are making good progress through these challenging times."

According to Chinese scientists, it should be possible to successfully treat critical COVID-19 pneumonia with the help of connective tissue stem cells, so-called mesenchymal stem cells from umbilical cord tissue. Since these cells are chemotactic, they migrate specifically to sites of inflammation, trigger regeneration processes and weaken the inflammatory reaction. This approach has now been taken up and positively evaluated in a specialist publication of the Harvard Medical School. This supportive therapy is currently being investigated in 19 clinical studies in Asia and Europe. "The results of most of these studies will not be available until later this year", explains CEO Dr. Wolfgang Knirsch, "If the results are positive, we expect that the regenerative potential of stem cells from umbilical cord blood and umbilical cord tissue will again receive increased attention".

Against the background of the stable business development in the first quarter and the previous indication for the second quarter, the Management Board of Vita 34 continues to adhere to its forecasts for the financial year 2020.

Contact:Ingo MiddelmenneInvestor RelationsVita 34 AGPhone: +49 (0341) 48792 - 0Mobile: +49 (0174) 9091190Email: ingo.middelmenne@vita34.de

Company ProfileVita 34 was founded in Leipzig in 1997 and is today one of the leading cell banks in Europe. As the first private umbilical cord blood bank in Europe and a pioneer in cell banking, the company has since then been a complete provider of cryopreservation services for the collection, processing and storage of stem cells from umbilical cord blood and umbilical cord tissue. Based on the expansion of the business model in 2019, Vita 34 intends to also offer the storage of immune cells from peripheral blood as well as of stem cells from endogenous fat in the future. Nursing cells are a valuable source of medical cell therapy and are kept alive at temperatures as low as minus 200 degrees Celsius to be used as part of a treatment when needed. More than 237,000 customers from more than 20 countries have already provided for their family's health with a cell depot at Vita 34.

14.05.2020 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Archive at http://www.dgap.de

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Business development of Vita 34 stable and unaffected by COVID-19 development so far - PharmiWeb.com

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The first UAE patient to recover from Covid-19 after stem-cell therapy has told of his gruelling journey to "full health" after being placed in a coma to stop his organs shutting down.

Abdullahi Rodhile, 50, from Somalia, contracted the virus on March 30 and, because of an existing heart condition, his health deteriorated quickly.

The virus attacked his kidneys and lungs so badly that doctors rushed him into the intensive care unit at Sheikh Khalifa Medical City in Abu Dhabi and put him in an induced coma for 20 days.

Whenever we called the hospital to ask about him, they would say 'just pray for him', Mr Rodhile's sister Zainab, 55, told The National.

Zainab said the family braced themselves for bad news after seeing global death tolls rapidly rise.

I was brought back to life. I was dead and now I am alive

Abdullahi Rodhile

With all this news, we lost our hope," she said. "I swear to God, I thought he was going to [die]. Even his wife prepared herself that he was not coming back.

A week after Mr Rodhile was admitted into the hospital, doctors from the Abu Dhabi Stem Cell Centre proposed a new therapy they believed could help to treat the effects of Covid-19.

Eager to try any treatment that could help, the family agreed and Mr Rodhile became the first Covid-19 patient in the UAE to be given stem cell therapy.

It involves isolating then activating stem cells taken from the patient's blood before they are nebulised into a fine mist so they can be inhaled into the lungs.

The therapy has since been used on 72 other coronavirus patients with severe symptoms.

I was brought back to life. I was dead and now I am alive, said Mr Rodhile, who works as a cargo clerk.

I have never been better. Thank God."

He spent 40 days in intensive care but only after he started the stem cell therapy did his lungs begin to improve slightly.

Mr Rodhile eventually healed enough to gradually awaken from the coma.

The first thing he did after he regained consciousness was call his sister.

He asked for his cell phone and asked them to dial my number," Zainab said. "It was 12am and I saw his name and I was in shock. I couldnt even move."

Mr Rodhile was disoriented and confused at first but slowly began to recover his strength.

I do believe that, after God, stem cell made his life different, his sister said.

Mr Rodhile is father to 10 children with his youngest aged only a month. His wife and children live in Somalia.

His stem cell treatment was free, in line with an order from Sheikh Mohamed bin Zayed, Crown Prince of Abu Dhabi and Deputy Supreme Commander of the Armed Forces, that all costs be covered for any critical coronavirus cases.

The treatment is considered "supportive". It is administered to patients alongside more conventional medical support and established treatment, rather than as a replacement.

"I am grateful and want to thank every person who has supported me and has taken care of me, and for Sheikh Mohamed and the UAE government for covering my treatment," Mr Rodhile said.

____________

Sheikh Mohammed calls for UAE to make 'fastest recovery' from pandemic

A medical worker puts away a Covid-19 swab test at one of the Mussaffah testing facilities. Victor Besa / The National

An Abu Dhabi resident goes for a jog along the Corniche, as the government eases movement restrictions. Victor Besa / The National

Abu Dhabi residents wear mandatory masks as they walk in the city.Victor Besa / The National

Safety instructions are on display outside Al Awir fruit & vegetable market in Dubai. Pawan Singh / The National

DUBAI, UNITED ARAB EMIRATES , May 6 2020 :- A person wearing protective face mask and covering his face with laptop bag on a hot day in Bur Dubai area in Dubai. UAE government ease the coronavirus restriction for the residents around the country. (Pawan Singh / The National) For News/Standalone/Online/Stock/Instagram

Indian citizens queue to check in at the Dubai International Airport before leaving the UAE on a flight back totheir home country on May 7. Inbound flights for UAE residents have also begun operatingfrom select cities.Karim Sahim / AFP

Passengers from an Emirates flight from London line up before being checked by health workers at Dubai International Airport on May 8. Karim Sahib / AFP

Al Wahda Mall in Abu Dhabi has reopened to the public but with safety measures in place. toprotect shoppers and staff from contracting Covid-19. Victor Besa/The National

Yas Mall in Abu Dhabi has reopened to the public from 12pm to 9pm. Measures remain in place to keep shoppers and staff safe. Victor Besa / The National

Abu Dhabi, United Arab Emirates, May 9, 2020. Yas Mall, Abu Dhabi will be open from noon to 9pm. Supermarkets and pharmacies will be open from 9am to midnight. Victor Besa / The National

Workers pass by Al Mina Vegetables and Fruits Market in Abu Dhabi. Victor Besa / The National

A security guard is given a free Covid-19 test at one of the Mussaffah testing centres. Victor Besa / The National

Workers line up to receive a coronavirus test at Abu Dhabi'sMussafah Industrial Area in Abu Dhabi. Victor Besa / The National

Updated: May 12, 2020 09:56 AM

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UAE's first Covid-19 patient to recover after stem-cell therapy tells of medical journey - The National

MINNEAPOLIS, May 14, 2020 /PRNewswire/ --The challenges surrounding COVID-19 have impacted every aspect of healthcare, including ensuring the timely delivery of bone marrow and blood stem cells for transplant. Thanks to the generosity of the Lockheed Martin Corporation, however, patients are able to continue receiving life-saving transplants without interruption.

When the National Marrow Donor Program (NMDP)/Be The Match ran out of available European Union couriers to deliver life-saving cells to American patients and with tens of thousands of commercial flights canceled, Lockheed Martin stepped up to offer their corporate aircraft as an in-kind donation to support the federal government's COVID-19 response and relief efforts to ensure patients that life-saving products from European donors would arrive on time.

NMDP/Be The Match, operates the federally authorized program that matches unrelated volunteer donors with patients in the United States and abroad who have been diagnosed with leukemia and over 70 more otherwise fatal blood disorders and diseases.

In addition to matching donors and patients, one of the program's primary missions is coordinating the delivery of bone marrow domestically and internationally to patients in the United States and abroad. This life-or-death delivery has historically been accomplished by trained couriers hand carrying donated marrow in the passenger compartment of commercial aircraft from donor collection centers to the hospitals of patients all across the globe.

Patients who are scheduled to receive transplants in the coming days are already in the process of a carefully timed course of chemotherapy and radiation treatments designed to eliminate their existing immune systems in preparation for the transplantation of cells to create a healthy, new immune system. If the transportation of donor cells is interrupted, the consequences are fatal to these patients whose immune systems have been ablated.

"The incredible support from Lockheed Martin is a lifeline to our patients. For those awaiting bone marrow transplant, their very survival depends on the on-time delivery of these life-saving cells. By offering flight services, Lockheed Martin is helping us ensure that patients can continue the cells they need, exactly when they need them," said NMDP/Be The Match Chief Policy Officer Brian Lindberg.

As part of this partnership Lockheed Martin will be providing weekly air transport based on government medical need flying government medical teams to the most critical, high-priority locations around the country and/or flying to support bone marrow transport to help with the government's COVID-19 response.

NMDP/Be The Match has facilitated over 100,000 bone marrow transplants since 1987 to deliver cures for patients battling blood cancers and blood disorders. More than 50 percent of those transplants involve international donors or recipients.

About Be The MatchFor people with life-threatening blood cancerslike leukemia and lymphomaor other diseases, a cure exists. Be The Match connects patients with their donor match for a life-saving marrow or umbilical cord blood transplant. People can contribute to the cure as a member of the Be The Match Registry, financial contributor or volunteer. Be The Match provides patients and their families one-on-one support, education, and guidancebefore, during and after transplant.

Be The Match is operated by the National Marrow Donor Program (NMDP), a nonprofit organization that matches patients with donors, educates health care professionals and conducts research through its research program, CIBMTR (Center for International Blood and Marrow Transplant Research), so more lives can be saved. To learn more about the cure, visit BeTheMatch.orgor call 1 (800) MARROW-2.

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Lockheed Martin Steps Up To Help Save Lives And Support Be The Match During COVID-19 - Southernminn.com

Dr Shikha Sharma

Coronavirus disease (COVID-19) is an unforgettable word in 2020. World health organization has declared COVID-19 as pandemic and according to the Worldometer site, it has affected 212 countries and territories and has caused approximately 2.8 lakhs deaths so far. According to the various published scientific evidences COVID-19 is an infectious disease caused by new coronavirus that can lead to lung dysfunction. There are 7 coronaviruses that are known to cause disease in humans and among these 3 can cause the severe respiratory infection. These are severe acute respiratory syndrome coronavirus (SARS-CoV) identified in 2002 in China, Middle East respiratory syndrome coronavirus (MERS-CoV) identified in 2012 in Saudi Arabia and severe acute respiratory syndrome coronavirus2 (SARS-CoV2) commonly called COVID-19 identified in late 2019 in Wuhan, China. SARS-CoV, MERS-CoV and COVID-19 are closely related but COVID-19 spread more quickly than the other two. Over 8000 people from 29 different countries were affected with SARS-CoV epidemic during 2002-2004 while 40.78 lakhs people are affected with COVID-19 so far. In most cases, immune response (bodys defence system) triggered by the COVID-19 infection is sufficient to combat its pathogenesis leads to the recovery of patient. However, in some cases, COVID-19 infection causes highly inflammatory form of lung cells death and injury as the most dangerous phase of its pathogenesis which leads to the overproduction of inflammatory cytokines by bodys own immune cells creating cytokine storm that results in damage to the lung tissues causing pneumonia, acute respiratory distress syndrome (ARDS) and sepsis. In Pneumonia and ARDS air sac of lungs fill with fluid or pus. These complications lead to severe condition such as shortness of breath that require treatment with oxygen and ventilator. Therefore controlling inflammatory response is utmost important to prevent coronavirus lethality rate and for the longer life of a patient. Currently no specific treatment is available for COVID-19 infection but several vaccines, drugs and stem cells testing in various countries has generated hope to combat its pathogenesis. Recent breakthrough has demonstrated mesenchymal stem cells (MSCs) as cell medicine therapy to reduce COVID-19 infection.What are MSCsMSCs are multipotent adult stem cells that are capable of differentiating into various cell types such as fat cells, bone cells, liver cells, pancreatic cells, brain cells, heart cells and skin cells thus can participate in the repair and regeneration of various tissues and organs of the body. Inside the body, upon injury, MSCs migrate to the injured site and participate in the regeneration and repair of the organ either by differentiation or by paracrine secretion or both. In addition MSCs possess immunomodulatory and anti-inflammatory properties that contributes to its cell medicinal properties. MSCs can be isolated from various tissues such as bone marrow, peripheral blood, body fat, muscle, placenta, umbilical cord, umbilical cord blood, teeth and hair follicles and can be expanded ex vivo and used for transplantation for treating disease and disorders after genetic stability test.How MSCs reduce COVID-19pathogenesisAs reported by various research groups that upon intravenous injection or through mist inhalation the significant population of MSCs migrate to the lung and secrete various immunomodulatory and anti-inflammatory factors to cure lung dysfunction by normalizing immune response altered by COVID-19 and stimulate lung repair. Moreover MSCs are resistant to COVID-19 infection and can be used for autologous and allogenic transplantation.Clinical trial with MSCs for COVID-19There are several clinical trials registered with MSCs for the treatment of COVID-19 from various countries such as China, USA, UK, Germany, UAE, Jordan and Iran and some reports have been published. Approximately 100 patients have been treated with MSCs therapy from moderate to critical conditions within 10-15 days of transplantation. A first case treated with MSCs showed the recovery of 65 year old critical ill patient in Baoshan Peoples Hospital, Longling County, China. Initially the patient was treated with antiviral therapy and immunomodulator thymosin alpha1 but hasnt shown any recovery. Later after 10 days patient was diagnosed with severe pneumonia, acute respiratory distress syndrome, multiorgan injury, type2 diabetes, moderate anaemia, electrolyte disturbance, immunosuppression, acute gastrointestinal bleeding and other symptom was shifted to ICU and on ventilator. They showed that after three MSCs injections along with thymosin alpha1 lead to the recovery of patient from COVID-19 infection. FDA has approved 24 patient clinical trial in USA to test safety and efficacy of MSCs from umbilical cord to prevent COVID-19 infection. Recently, in USA three critically ill patients in ICU and on ventilator recovered from COVID-19 infection with MSCs treatment. An Israeli pharmaceutical company Pluristem therapeutics have tested MSCs therapy on 7 critically ill patient and found positive results. More recently, UAE also reported the treatment of 73 COVID-19 infected patients with stem cells. They have developed the technology to isolate the stem cells from patient blood, activate them and reintroduce them by mist inhalation. These reports are indicative that MSCs hold the potential to treat the COVID-19 infection by preventing bodys own defense system from overreacting and normalise its response to fight against COVID-19 infection. Many companies from different countries are seeking approval to begin clinical trial with stem cells against COVID-19 infection.Why are we lagging behind when we have stem cell companies/labs/facility in our country? We also produce GMP grade stem cells for transplantation. China tested the stem cell therapy on first patient when all other therapies failed and stem cells was one of option left to save the life of the patient. In India also so many deaths are happening due to COVID-19 we can also check if stem cells can reduce the mortality rate. Moreover as per some reports MSCs dont stay inside the body for more than 1-3 months and they eventually die and dont result in teratoma formation. Our government along with doctors and scientist can also formulate committee on stem cells and begin such initiative to test MSCs for the treatment of COVID-19 infection. Nevertheless, MSCs has joined the army along with the other possible interventions to prevent the COVID-19 illness.(The author is (PhD and Postdoc in Stem Cells)feedbackexcelsior@gmail.com

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Stem cells therapy A prospective treatment against coronavirus? - Daily Excelsior

News

Secondary bacterial infections are emerging as a risk-multiplier for coronavirus patients with drug-resistant infections a particular threat.

During the 1918 Spanish Flu pandemic, many people succumbed not to the influenza virus, but to secondary pneumonia, as opportunistic bacteria took advantage of a weakened immune system and invaded the lungs.An influential 2008 Journal of Infectious Diseases study co-authored by leading US infectious disease expert Dr Anthony Fauci found most Spanish Flu deaths were in fact due to bacterial pneumonia.These infections were hard to treat, given the virulent strain of flu emerged a decade before the first antibiotic, penicillin, was discovered.If the next pandemic is caused by a human-adapted virus similar to those recognized since 1918, we believe the infection is likely to behave as it has in past pandemics, precipitating severe disease associated with prevalent colonizing bacteria, the study authors conclude. Now this prediction looks to be coming true. Experts are warning that history may be repeating a century later during a new pandemic, with secondary bacterial infections emerging as an understudied way people can die from COVID-19. We have antibiotics this time but overuse of the vital drugs has led to the emergence of strains of antibiotic-resistant organisms.Not only that, the current global pandemic may supercharge the growth of antibiotic-resistant organisms, given many hospitalised coronavirus patients are routinely given antibiotics to reduce the risk to healthcare workers. The COVID-19 pandemic has led to huge numbers of people with compromised immune systems being admitted to hospitals, which are a known breeding ground for drug-resistant bacteria. Because of this influx, these hospital-associated bacteria will now have a much wider potential target group, microbiologist Dr Ronel McCarthy notes in The Conversation.Infectious disease expert and ANU microbiologist Peter Collignon told newsGP it is doubly concerning given that increasing antimicrobial resistance may make these infections harder to treat.During the Spanish Flu, between half and three quarters of the deaths were linked to secondary bacterial infections. In a study from Wuhan, half the [COVID-19] patients who died had a secondary bacterial infection. Thats quite high, he said.The Wuhan study in The Lancet was small, involving 191 patients who already had advanced COVID-19, leading antibiotic resistance research network ReAct to caution that the secondary infections were very late stage, with sepsis and acute heart and kidney injuries having occurred in many patients, and to call for more research.Professor Collignon predicted that mortality rates will be worse in nations with higher rates of antimicrobial resistance, such as China, Italy and India.Where is the worst antibiotic resistance in Europe? Italy and Spain. The death rates there are considerably higher, he said.Theres a much higher chance that if you get a secondary bacterial infection it wont respond to antibiotics, he said.I have a view that antibiotic resistance is important in this pandemic. It makes sense. If you go into an ICU [for any reason], a proportion get secondary bacterial infections.India had the highest rate of resistance of 41 nations in a 2018 BMJ study, while Chinas gram-negative bacterial resistance is severe, according to a 2019 Frontiers in Microbiology study.Indias National Centre for Disease Control has called on state health authorities to ensure hospitals adopt strict infection prevention guidelines to stop transmission of both coronavirus and bacterial infections.An anonymous national health official told Indian newspaper Mint that the move was to stem the impact of antimicrobial resistance.[Antimicrobial resistance] can indirectly impact the outcomes of treatment in COVID-19 patients. We have asked all the hospitals to adopt the guidelines while treating coronavirus patients, the official said.Almost all COVID-19 cases in India conclude in serious pneumonia, Dr K Madan Gopal of Indias NITI Aayog thinktank told Mint. Now, if this secondary infection is triggered by antibiotic-resistant bacteria then the situation becomes grave and harder to treat.Adding to the issue is the fact hospitalised coronavirus patients in some countries have been given antibiotics without a confirmed infection in order to reduce the risk to doctors from aerosol-generating diagnostic procedures, according to microbiologist Dr Adam Roberts.Dr Roberts and collaborators have collated emerging research on secondary infections and antibiotic use, such as a Lancet study flagging increasing concern that COVID-19 patients are at risk of contracting a dangerous fungal infection, invasive pulmonary aspergillosis.Virologist Jeffery Taubenberger, who first sequenced the genome of the Spanish Flu, has told Bloomberg that secondary bacterial infections in the lungs can prevent patients from recovering due to the damage they can do to respiratory tract stem cells. [Without these cells] you just cant physically repair your lungs he said.People who have a mild reaction to the coronavirus tend to be those able to contain it to the upper respiratory tract. Worse trajectories occur if the virus is able to move to the lungs, potentially paving the way for a secondary assault by bacteria, according to Dr Taubenberger, who was a co-author of the 2008 Spanish Flu study.Paul Glasziou, Professor of Evidence-Based Practice at Bond University, told newsGP it is likely that countries with high numbers of COVID-19 cases will also have increased rates of antimicrobial resistance.A lot of the seriously ill cases get secondary infections. If you have higher rates of antimicrobial resistance, youre going to have more deaths because you wont be able to treat the secondary infections, he said.But Professor Glasziou said antimicrobial resistance could actually decrease in nations like Australia, where the infection has been broadly contained, given that many people have been avoiding GPs and hospitals thus reducing the number of antibiotics prescribed.You have an increased use of antibiotics for hospitalised COVID-19 cases but, at the same time, youve got a reduction in ambulatory care visits with the number of people seeing GPs down and elective surgery put off or cancelled, he said.Social distancing and handwashing have also slashed rates of influenza and other respiratory infections.As well as stopping coronavirus, these interventions also stop every other acute respiratory infection and thats the major area of [antibiotic] overuse in primary care, Professor Glasziou said.What it means long term is hard to say; it depends on what behaviours are changed by this.We may have changed some behaviours permanently and that could lead to long-term reductions in acute respiratory infections. And that could help us long term with antimicrobial resistance.Thats my hope Ive got my fingers crossed. It will be interesting to look at.Log in below to join the conversation.

antimicrobial resistance coronavirus COVID-19

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Are infections and antimicrobial resistance linked to pandemic deaths? - RACGP

In John M. Barrys book on the 1918 flu pandemic, The Great Influenza, one of the most striking passages concerns what actually killed many of the young, healthy victims of the infection, causing them to turn blue and bleed from the nose or ears:

The virus was often so efficient at invading the lungs that the immune system had to mount a massive response to it. What was killing young adults a few days after the first symptom was not the virus. The killer was the massive immune response itself.

The phenomenon Barry describes is the cytokine storm, or cytokine release syndromewhen a bodys natural defenses are called into action and are so overwhelming and destructive that instead of rescuing the sick, they cause their death.

Cytokines are small signaling proteins, which can be grouped by their origins, structural characteristics, effects on the body, and signaling pathways. Each type has a corresponding receptor on the cell surface and, once received, can start one of a number of cellular tasks that begin a cascade of responses, depending on type.

Microbial infections are not the only cause of these storms; a more familiar one is graft versus host disease, which can occur in people who receive organ, bone-marrow, or stem-cell transplants. The donor organ detects an invader (the new body) and masses an immune response to stop the threat, which endangers both the transplanted organ and the recipient. People who receive organ transplants are often given steroids and immunosuppressors to prevent and/or counteract these responses.

Cytokine release syndrome has been reported in some COVID-19 patients, particularly young ones.Unlike other viruses and causes, COVID-19-associated cytokine storms do not appear to inflict severe liver damage. Conversely, the damage to the lungs from the disease is much greater, which may be due to the localization of the virus to those of the lower respiratory tract. Patients kidneys may also be damaged, which accounts for thereporting of acute shortages of dialysis machines for those with already existing renal issues.

The tools available to medicine in 2020 were only at best theoretical in 1918. The lethality of COVID-19 is overwhelming, and the list of complications to infection continues to grow as more cases are seen. The lessons of the influenza pandemic are aiding health care today, and the ability to intervene in cytokine storms early may be saving lives this time.

JSTOR is a digital library for scholars, researchers, and students. JSTOR Daily readers can access the original research behind our articles for free on JSTOR.

By: W. Conrad Liles and Wesley C. Van Voorhis

The Journal of Infectious Diseases, Vol. 172, No. 6 (Dec., 1995)

Oxford University Press

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Cytokine Storms: The Cruel Irony of an Immune Response - JSTOR Daily

DetailsCategory: Small MoleculesPublished on Tuesday, 12 May 2020 12:04Hits: 667

Pediatric Investigational Plan (PIP) for leriglitazone in X-ALD approved by EMA, allowing Minoryx to file Marketing Authorization Application (MAA) in Europe based on NEXUS

Timelines for other ongoing trials not impacted by COVID-19 pandemic

MATAR, BCN, Spain and CHARLEROI, Belgium I May 12, 2020 I Minoryx Therapeutics, a company that specializes in the development of innovative treatments for orphan Central Nervous System (CNS) diseases, today announces the initiation of the registration-enabling Phase 2 NEXUS trial to evaluate the safety and efficacy of leriglitazone in pediatric patients with early-stage cerebral ALD (cALD), the acute form of X-linked adrenoleukodystrophy (X-ALD).

In addition the European Medicines Agency (EMA) approved the proposed PIP for leriglitazone for the treatment of X-ALD, allowing the company to file for an MAA in Europe based on the Phase 2 NEXUS trial, subject to positive results. Minoryx received a deferral for completion of its pediatric plan until after EMA approval of adrenomyeloneuropathy (AMN).Leriglitazone (MIN-102), a novel, brain penetrant, orally bioavailable and selective PPAR agonist, is currently in late-stage development for the treatment of severe orphan CNS disorders, including both forms of X-ALD (cALD and AMN) and Friedreichs Ataxia. Leriglitazone obtained Orphan Drug Designation in X-ALD from the European Commission and the FDA, and has been awarded the FDA fast-track procedure in X-ALD.With newborn screening currently being implemented, it is now possible to diagnose patients with early stage cALD, an orphan neurodegenerative disorder characterized by rapid cerebral demyelination and inflammation of the brain, leading to death within a few years of diagnosis. There is an urgent need for alternative treatments that are less invasive than the current standard of care, which is based on hematopoietic stem cell transplantation, said Dr. Patricia Musolino, principal investigator of the study and Assistant Professor in Neurology at the Harvard Medical School. The first patient, a ten-year-old boy, has been enrolled in the NEXUS trial at the Hospital Sant Joan de Du in Barcelona. We look forward to further supporting the company and to bringing this much needed innovation to pediatric patients suffering from this devastating disease.Mara Pascual, Chief Regulatory Officer of Minoryx, added: This EMA approval of the PIP, based on the NEXUS trial, marks an important milestone for the company. It highlights the importance of making alternative safe and effective treatments available for children with early cALD. It not only provides a clear path for faster registration of leriglitazone in childhood cerebral ALD but also paves the way for submission of the MAA in Europe for leriglitazone in adrenomyeloneuropathy, following successful completion of the ongoing Phase 2/3 ADVANCE trial.We are pleased that the first patient has been enrolled in the NEXUS trial and expect to report results in 2021, with the potential for preliminary results as soon as this year, said Marc Martinell, Chief Executive Officer of Minoryx.

Despite the current COVID-19 pandemic, the timelines of the other ongoing trials with leriglitazone in adrenomyeloneuropathy and Friedrichs Ataxia have not been impacted. Always putting the safety and needs of our patients first, we continue to work diligently with the study sites and our CRO to complete these trials. We still expect to report results for both trials by the end of 2020.About the NEXUS trialand the PIPThe NEXUS registration-directed Phase 2 clinical trial is an open-label study designed to assess the efficacy and safety of leriglitazone in male pediatric patients with early stage cerebral X-linked adrenoleukodystrophy (cALD). In addition to Spain, the trial has also been approved by ethical committees and the regulatory agencies in France and Germany. Alongside the Barcelona study site under the supervision by Dr Angeles Garca-Cazorla, other recruitment sites include the University Medical Center Hamburg-Eppendrf, with Dr Anette Bley, the University Hospital Gttingen under the supervision of Dr Hendrik Rosewich and the Bictre Hospital in Paris with Dr Caroline Sevin.The NEXUS trial will recruit up to 13 cALD patients with early cerebral MRI lesions. All patients will receive leriglitazone and will be carefully monitored for safety, clinical symptoms and changes in cerebral MRI lesions. The study has been designed with input from both the EMA and the FDA, clinical experts in X-ALD in Europe and the US, and patient advocacy groups. The trial is partially funded by the European Union's Horizon 2020 research and innovation programme (SME instrument) under grant agreement No 822968.The PIP for leriglitazone is based on the NEXUS trial and has been approved by the EMA following positive opinion from its Pediatric Committee (PDCO). The PIP includes a deferral in completion of the trial until after the approval of the MAA for leriglitazone in adrenomyeloneuropathy (AMN), the most common form of X-ALD. With successful completion of the agreed PIP, leriglitazone will be eligible for two additional years of marketing exclusivity, on top of the ten-year market exclusivity after market approval.About X-ALD and cALDX-ALD (X-linked adrenoleukodystrophy) is the most prevalent peroxisomal disease. It is caused by mutations in the ABCD1 gene. It has an estimated incidence of 1:17,000 newborns worldwide. Although it primarily affects males, heterozygous women may also develop the disease in later life. X-ALD is characterized by the accumulation of very long chain fatty acids (VLCFA), leading to a neurodegenerative disorder where the most affected tissues are the spinal cord, the brain and the adrenal cortex. The CNS-related effects lead to two main phenotypes: adrenomyeloneuropathy (AMN), characterized by progressive motor dysfunction, and cerebral ALD (cALD), characterized by severe neuroinflammation leading to early death. The only alternative to manage cALD is hematopoietic stem cell transplantation (HSCT) but this approach does not prevent the development of AMN during adulthood, for which there is currently no approved treatment option available.About leriglitazoneLeriglitazone (MIN-102) is a novel, brain penetrant, orally bioavailable and selective PPAR agonist that engages the target receptor at the levels required for efficacy within the central nervous system (CNS). It has demonstrated efficacy in animal models of multiple disease modulating pathways leading to mitochondrial dysfunction, oxidative stress, neuroinflammation, demyelination and axonal degeneration. Leriglitazone has the potential to treat several CNS disorders, including orphan diseases, such as X-ALD (X-linked adrenoleukodystrophy) and Friedreichs Ataxia. A Phase 1 clinical study was successfully completed confirming that leriglitazone is well tolerated and is able to cross the blood brain barrier and engage PPAR within the central nervous system at an equivalent level as in preclinical studies. Leriglitazone has completed enrolment in ADVANCE, a two-year double-blind, placebo-controlled, pivotal Phase 2/3 study in adult patients with adrenomyeloneuropathy (AMN)and recruitment is ongoing in NEXUS, a pivotal open-label study in pediatric cALD patients. Leriglitazone has also completed enrolment in FRAMES, a one year double-blind, placebo-controlled Phase 2 study in patients with Friedreichs Ataxia. Results from ADVANCE and FRAMES are expected by the end of 2020and results from NEXUS are expected in 2021. Leriglitazone has obtained Orphan Drug Designation from the European Commission and the FDA in X-ALD and Friedreichs Ataxia.About Minoryx TherapeuticsMinoryx is a clinical stage biotech company focusing on the development of novel therapies for orphan CNS diseases with high unmet medical needs. The companys lead program, leriglitazone (MIN-102), a novel, selective PPAR agonist, is currently being evaluated in X-ALD and Friedreichs Ataxia. The company is backed by a syndicate of experienced investors, which includes Ysios Capital, HealthEquity, Kurma Partners, Chiesi Ventures, Roche Venture Fund, Caixa Capital Risc, Idinvest Partners, Fund+, S.R.I.W, Sambrinvest and SFPI-FPIM, and has support from a network of other organizations. Minoryx was founded in 2011, has operations in Spain and Belgium and has so far raised a total of more than 50M.www.minoryx.com

SOURCE: Minoryx Therapeutics

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Minoryx Therapeutics doses first patient with leriglitazone in registration-enabling cALD NEXUS trial | Small Molecules | News Channels -...

CINCINNATI, May 12, 2020 The explosion in cellular immunotherapy that has revolutionized cancer care in recent years may soon begin showing potential application in treatment for lupus and other autoimmune diseases, thanks to a laboratory breakthrough led by experts at Cincinnati Children's and published in the journal Cell Reports Medicine.

In cancer, CAR T-cell therapy involves engineering T cells with chimeric antigen receptors (CAR) that allow them to recognize specific molecules on the surface of tumor cells. For certain forms of leukemia, some lung cancers, and other malignancies, this form of cellular immunotherapy has been life-changing for patients. Recent evidence suggests engineering natural killer (NK) cells to express CAR may be equally effective as T cells but with increased safety and clinical feasibility.

There is growing interest in the safety and efficacy of applying CAR cellular therapies to deadly and incurable autoimmune diseases. However, finding specific cell targets for diseases such as lupus has been much more difficultuntil now.

In a first-of-its-kind discovery, a team of Cincinnati Children's scientists led by Seth Reighard, PhD, Stephen Waggoner, PhD, and Hermine Brunner, MD, MSc, MBA, has engineered a CAR with the potential to revolutionize care of patients with lupus. When expressed by human NK cells, this CAR enables targeted elimination of T follicular helper (TFH) cells without harming other types of T-cells.

This treatment showed specificity in human cells in lab tests, and improved disease measures in a humanized mouse model of lupustwo key early signs of progress that suggest further research is warranted.

"This is the first method to specifically remove an otherwise intractable population of harmful cells," Waggoner says. "We think targeting them will be safe and clinically beneficial in multiple diseases. Our approach started with lupus because the disease is a leading cause of death in young women for which a cure is presently lacking."

The study appears in the first issue of the new, open access journal Cell Reports Medicine, which also carries a commentary about this new approach from Cecile King, PhD, an immunology expert at the Garvan Institute of Medical Research in Australia.

"Dysregulated TFH cells are associated with the development and severity of several autoimmune diseases and T cell malignancies," King states. "Indeed, the central role of TFH cells in many diseases has made them a major target for therapeutic modulation. The study by Reighard et al. provides exciting proof-of-principle evidence for the use of CAR NK cells in TFH-driven diseases."

How do CAR NK cells work?

The lupus-driving cells that the team wanted to eliminate lack cell-surface targets unique enough to distinguish them from other, desirable cells. To achieve selective targeting, the team realized a cardinal feature of TFH cells that could be exploited by carefully engineering the biochemistry of the CAR molecule.

Specifically, TFH express much greater quantities of a surface receptor, programmed cell death protein 1 (PD-1), than other cells that also express this receptor. Since activation of a CAR expressing NK cell is dependent on the strength of interaction between the CAR and its target receptor, as well as the number of such interactions between an NK cell and a target, the team engineered a CAR with relatively weak binding to PD-1. As a result, only cells like TFH that exhibit high expression of PD-1 trigger activation of the CAR NK and are eliminated as a result, which cells with lower levels of PD-1, including regulatory T cell (Treg) and memory T cells, are spared.

These programmed killer cells show early signs of potential as a therapy for systemic lupus erythematosus (SLE), which affects 20-150 per 100,000 people in the U.S. In fact, lupus ranks in the five causes of death among African American and Hispanic women, aged 15-34.

In addition, aberrant TFH responses play roles in several other autoimmune diseases, including Sjgren syndrome, juvenile dermatomyositis, multiple sclerosis, type 1 diabetes, and rheumatoid arthritis.

Although the potential toxicity of selectively eliminating TFH remains unexplored, the preservation of naive and memory CD4 T cells as well as B cells and other types of immune cells suggests that the state of immunodeficiency induced by these CAR NK cells will be far less severe than other immunotherapeutic strategies applied to autoimmune disease (e.g., rituximab).

Discovery based on years of research

This advance in CAR technology build upon previous work by Waggoner and colleagues in 2015 and 2018 that revealed how NK cells play surprising regulatory roles in infection and autoimmune disease.

The conceptual connections between infections and autoimmune diseases were further strengthened by a discovery led by John Harley, MD, PhD, and colleagues at Cincinnati Children's. In a 2018 study in Nature Genetics, they revealed how the Epstein-Barr virus uses groups of transcription factors to alter human DNA in ways that can increase a person's risk of developing lupus, multiple sclerosis, type 1 diabetes, and other diseases.

What's Next?

More work is needed to determine how much benefit can be gained by disrupting the role of TFH cells in lupus and other conditions. Concerns to address also include how to prevent the killer cells from attacking non-targeted "good" cells, and how to efficiently deliver the therapeutic cells.

Researchers are working to develop "suicide switches" for CAR NK cells that would make them safer for clinical use, Waggoner says. But importantly, NK cells appear to pose lower toxicity risk than CAR T-cell therapies in multiple clinical trials in cancer patients. Given the contributions of T cells to disease pathogenesis in lupus and other autoimmune disease, therapeutic NK cells likely yield additional benefit in these contexts.

Although the present study was performed with a human NK-cell line approved for clinical use by the FDA, the team envisions flexibility in the clinical application of the new CAR to lupus. CAR engineering of patient cells or cells from unrelated donors, including cord blood or induced pluripotent stem cell-derived NK cells, have all demonstrated excellent safety profiles while maintaining desirable efficacy in clinical trials.

"The CAR can be introduced to various effector cells using mRNA transfection, transposons, or viral vectors, Waggoner says. "Freezers full of CAR-expressing induced pluripotent stem cell-derived NK cells would provide an off-the-shelf product that could be rapidly and repeatedly administered to numerous patients in order to quell harmful flares of disease activity and promote sustained disease remission.

"If successes continue, a clinical trial might be possible within the next few years," Waggoner says.

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SOURCE Cincinnati Children's Hospital Medical Center

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Novel CAR NK-cell technology could lead to new treatments for lupus, other incurable diseases - Stockhouse