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Here are the best ways to strengthen your immune system during the coronavirus pandemic – The Dallas Morning News

April 17th, 2020 2:42 am

Although there is no cure or specific treatment for COVID-19, there are some things you can do to strengthen your immune system against the coronavirus.

Here are scientifically supported ways to help fight off illness.

The amount of sleep youre getting each night can make a big difference in your bodys ability to fight infection, health experts say.

One 2015 study found that people who sleep less than six hours each night were more likely to catch a cold than those who slept seven or more.

The U.S. Centers for Disease Control and Prevention recommends that adults sleep at least seven hours each night. Going to bed and waking up at the same time each day, sleeping in rooms without electronics or screens, and avoiding large meals, caffeine and alcohol before bed are ways to improve your sleep.

Research shows that regular, moderate exercise can reduce inflammation and support your immune systems cells.

Health experts recommend moderate exercise at least 150 minutes each week, or about 20 minutes a day. You can also do 75 minutes of more intense exercise a week, or do a combination of both.

Moderate exercise includes brisk walking, biking, swimming or jogging, while more intense exercise includes running or other cardio.

Staying hydrated isnt directly connected to preventing disease, but it can help with your overall health.

Healthline says you should drink enough water each day to make your urine a pale yellow, while other health experts recommend drinking eight glasses of water a day, or about half a gallon.

In this age of uncertainty, lowering your stress level is easier said than done. But health experts say high stress levels have negative impacts on your bodys ability to fight off illness.

A series of studies in the 1990s led by Sheldon Cohen, a professor of psychology at Carnegie Mellon University, found that people who reported higher levels of stress were more susceptible to the common cold.

Cohen led another study published in 2012 that found psychological stress can cause the body to lose its ability to regulate its inflammatory response, which may promote the onset and progression of some diseases.

Health experts recommend stress management techniques such as avoiding social media, meditating, practicing controlled breathing, doing yoga, or other activities that help you feel relaxed.

No one food will prevent infection, but following basic dietary guidelines, like eating plenty of fruit, vegetables and protein is a good start.

There are several specific items you can add to your diet to strengthen your immune system and overall health.

Health experts recommend eating certain foods that are high in vitamin C, like red bell peppers, broccoli, strawberries, spinach and citrus fruits like oranges, lemons and grapefruit. Sunflower seeds and almonds are recommended because they are high in vitamin E, while other foods, like yogurt, garlic, poultry and chickpeas, have other health benefits.

Ginger, turmeric, green tea, papayas, kiwis, shellfish and mushrooms are also good items to add to your diet, health experts say.

Texans may be eager to take advantage of alcohol delivery and to-go cocktails since Gov. Greg Abbott waived regulations restricting restaurants from providing such services. But health experts say you should be careful about how much you drink if you want to put your body in a good position to fight off disease.

Research shows excess alcohol consumption can make your body more susceptible to respiratory illness, including pneumonia and other lung diseases. It can also decrease your body tissues ability to heal wounds. Health experts say this is true for chronic and binge drinkers.

While health experts say the occasional glass of wine at dinner wont hurt you, you should avoid overdoing it.

Health experts have differing opinions on the use of vitamins and other supplements. They can be pricey and they dont prevent anyone from catching a disease, no matter how much you take.

Health experts say other disease prevention methods, like frequent hand-washing, will help you more than any supplement will.

However, there is some evidence that regularly taking certain supplements can reduce the duration of certain illnesses.

One 2013 study found that regularly taking vitamin C reduced the duration of colds in adults by 8% and in children by 14%. A similar 2017 study found that the duration of colds among people taking more than 75 mg of zinc per day was 33% shorter than those who didnt take zinc.

An exception to the supplement rule that most health experts agree on is vitamin D, which helps your body fight off infection. You can get vitamin D naturally through certain foods, like salmon, or through exposing your body to sunlight. Some health experts recommend taking a vitamin D supplement during winter months, when sunlight is harder to come by.

If youre going to take supplements, its important not to take too many. Some health and wellness influencers and YouTubers have recommended taking extremely high doses of supplements in recent weeks in response to COVID-19. But health experts warn that can be dangerous. Taking high doses can cause dizziness, nausea and headaches and damage your organs in more serious cases.

Healthline recommends taking supplements that have been tested by a third party, such as United States Pharmacopeia, NSF International and ConsumerLab, because supplements arent regulated by the U.S. Food and Drug Administration.

Practicing habits to strengthen your health does not mean you should stop following other public health guidelines. You should still practice social distancing, avoid nonessential errands, wash your hands often, wear a face mask in public and follow stay-at-home orders, health experts say.

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Stem Cell Therapy Market to 2027 – Global Analysis and Forecasts by Type; Treatment; Application; End User, and Geography – Salamanca Press

April 16th, 2020 1:45 pm

NEW YORK, April 15, 2020 /PRNewswire/ -- The stem cell therapy market was valued at US$ 1,534.55 million in 2019 and is estimated to reach US$ 5,129.66 million by 2027; it is expected to grow at a CAGR of 16.7% from 2020 to 2027.

Read the full report: https://www.reportlinker.com/p05882135/?utm_source=PRN

The increasing awareness related to the stem cells therapy in effective disease management and growing demand for regenerative medicines are the key factor driving the stem cell therapy market. However, high cost related of the stem cell therapy limits the growth of the market.Stem cell research has been widely investigated globally for various medical applications, especially for the treatment of humans.This raises the importance of creating public awareness about stem cell research and its clinical potential.

The main role of stem cells is in the replacement of dying cells and reconstruction of damaged tissues. Based on the extensive stem cell research, many scientists have claimed that these cells could probably be used in the treatment of various diseases, including cancer and cardiovascular disease.There is a large number of potential treatment procedures that are undergoing clinical trials, and a notably few stem cell therapies have won FDA (i.e., US Food and Drug Administration) approval for clinical usage. For instance, in 2019, the FDA approved Fedratinib for the first-line treatment for myelofibrosis. Moreover, stem cell therapies are widely used in bone marrow transplantation, and these therapies have benefited thousands of people suffering from leukemia. Hematopoietic stem cells are used for treating more than 80 medical diseases, including immune system disorders, blood disorders, neurological disorders, metabolic disorders, genetic disorders, and several types of cancers, such as leukemia and lymphoma; this is also likely to boost the demand for this treatment procedure during the forecast period. Researchers are further investigating the use of stem cell therapies in the treatment of autoimmune disorders.

The global stem cell therapy market has been segmented on the basis of type, treatment, application type, and end user.Based on type, the market has been segmented into adult stem cell therapy, induced pluripotent stem cell therapy, embryonic stem cell therapy, and others.

The adult stem cell therapy held the largest share of the market in 2019; however, induced pluripotent stem cell therapy is estimated to register the highest CAGR in the market during the forecast period.Based on treatment, the stem cell therapy market has been segmented into allogeneic and autologous.

The allogeneic segment held a larger share of the market in 2019; however, the market for the autologous segment is expected to grow at a higher CAGR during the forecast period.Based on application type, the stem cell therapy market has been segmented into musculoskeletal, dermatology, cardiology, drug discovery and development, and other applications.

The musculoskeletal segment held the largest share of the stem cell therapy market in 2019, whereas the drug discovery and development segment is expected to report the highest CAGR during 20202027. Based on end user, the market has been segmented into academic and research institutes, and hospitals and specialty clinics. The academic & research institutes held the largest share of the market in 2019, and it is also expected to report the highest CAGR during the forecast period.Several essential secondary sources referred to for preparing this report are the FDA, World Health Organization (WHO), Organisation for Economic Co-operation and Development, National Institutes of Health, Spanish Agency for Medicines (AEMPS), Japanese Society for Regenerative Medicine, and Indian Council of Medical Research, among others.

Read the full report: https://www.reportlinker.com/p05882135/?utm_source=PRN

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Los Angeles Periodontists use blood-derived growth factors as an alternative to treating gum recession – PRNewswire

April 16th, 2020 1:45 pm

Gum recession puts patients at risk of developing decay, causes tooth sensitivity, and creates an unattractive smile. "Gum recession is most commonly caused by gum disease, which affects nearly 65 million Americans annually. Many patients avoid treatment because of the painful, invasive nature of a gum graft that typically uses gum tissue from the roof of the mouth, increasing post-operative pain and suffering. The RejuvaGum Lift offers patients a gentle yet effective alternative to gum grafting, with less recovery time and enhanced healing," says Dr. Alina Krivitsky.

The Brentwood periodontists utilize cutting-edge technology to offer their patients advanced periodontal care. "Several samples of a patient's blood are spun in a centrifuge to separate the platelets, white blood cells and fibrin. When applied directly to a wound, the proteins in the fibrin encourage faster healing by causing the wound to close more quickly, and increase blood flow to the site. The extra boost of stem cells and growth factors assist in soft tissue regeneration around the exposed roots, and by utilizing the patient's own immune system to heal, the risk of infection is almost none," says Dr. Aalam.

To learn more about the RejuvaGum Lift treatment for gum recession, please visit https://implantperiocenter.com/or contact them at 310-504-1845.

About the CENTER for Advanced Periodontal & Implant Therapy

At the CENTER for Advanced Periodontal & Implant Therapy, Dr. Aalam and Dr. Krivitsky utilize advanced technology coupled with cutting-edge techniques to provide minimally-invasive, comfortable and effective periodontal care. As the only dual-board certified practice in Brentwood, California, they are committed to providing restorative periodontal therapies to rejuvenate the aesthetics, health, and function of the gums and teeth, to help patients achieve a healthier smile.

Contact: Charlene Yashouafar, Marketing DirectorSocial Lighthouse[emailprotected](213) 403-1407

SOURCE The CENTER for Advanced Periodontal & Implant Therapy

WELCOME TO YOUR LOS ANGELES PERIODONTISTS

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Leading the Movement Towards Direct Cell Conversion: An Interview With Mogrify – Technology Networks

April 16th, 2020 1:45 pm

Biotech company Mogrify is deploying its proprietary direct cellular conversion technology to develop cell therapies in a variety of disease areas, including auto-immune, musculoskeletal, respiratory diseases and in cancer immunotherapy.The platform utilizes data from next-generation sequencing and cellular networks to identify transcription factors or small molecules required to directly convert a cell, addressing key challenges that are typically associated with the safety and efficacy of cell therapies.Technology Networks recently spoke with Joe Foster, COO, Mogrify, to learn more about the platform, the challenges encountered in developing cell therapies, and to gain Mogrify's insights on the future of this exciting research space.Molly Campbell (MC): What were some of the major highlights for Mogrify in 2019?Joe Foster (JF): In the past year, Mogrify has solidified its reputation as a pioneer in the expanding field of cell therapy. Using a systematic, data-driven approach, our innovative cell conversion platform addresses many of the challenges impeding systematic discovery, process development and the manufacturing processes.At an operational level, Mogrify has seen unprecedented growth in the last year, with emphasis on world-class science. We have established a leadership team with unparalleled track records, including the appointment of Dr Darrin M. Disley OBE, as CEO and Dr Jane Osbourn OBE, as Chair. Looking forward and with plans to boost our team to 70 individuals working across all disciplines, Mogrify has also moved operations to the new Bio-Innovation Centre in Cambridge, giving our team access to state-of-the-art facilities to continue their work in developing novel approaches to cell therapy.Mogrify received MSDs Innovation Award at the 15th Annual Scrip Awards, in acknowledgement of our potential to transform future cell therapies. Dr Jane Osbourn OBE was also the first female to win the Lifetime Achievement Award, recognizing her significant contributions to the biotech industry. Mogrifys significant fundraising success was also marked at the prestigious European Lifestars Awards, which celebrates excellence in the life science industry. Here, Mogrify was recognized as the Seed Stage Finance Raise of the Year.MC: In Mogrify's opinion, what key trends can we expect to see in the cell therapy space in 2020?JF: Many of the current approaches to cell therapy involve first converting cells back into a stem cell-like stateinduced pluripotent stem cellsbefore then converting them into the cell type required.Mogrify plans to lead the movement towards direct cell conversion, or transdifferentiation, where cells can be transformed from one cell type to another, without having to go through an intermediate pluripotent stage. Direct conversion of cells would enhance the speed of cell therapy development, as cells do not need to use traditional developmental pathways to reach a mature state.

Another bottleneck in the delivery of cell therapies is that most approaches rely on autologous transplants, which are carried out using patient-derived cells. Future innovations are moving towards using allogeneic therapies, where the cells used for therapy are derived from a healthy donor. Such advances are paving the way towards the development of universal donor cells, which would turn cell therapies into off-the-shelf treatments, enhancing the scale and accessibility of the treatments.

Finally, cell therapy methods are likely to move from ex vivo approaches (where cells are isolated from the patient, reprogrammed, and delivered back into the patient), to in vivo approaches, where cell therapies are delivered directly to the recipient, for example, through the use of small molecules present in a reprogramming cocktail or direct gene editing. In vivo technologies would, therefore, be able to reprogram cells directly in living humans, expanding the scope of cell therapy in a clinical setting. Overall, future cell therapies will have the capacity to be more effective, safer, and widely accessible.

MC: What are the key challenges that currently exist when developing and testing cell therapies? How does Mogrify hope to overcome such challenges?JF: The biggest challenges in producing cell therapies surround the efficacy, safety profile, and scalability of clinical treatment regimes. To make treatments safer, delivered cells must bypass the host immune system. This can be achieved with autologous therapy, but comes at the cost of scale and efficiency, as the patients cells need to be extracted, cultured, and reprogrammed before treatment can be delivered. Genetic engineering technologies (such as CRISPR/Cas9) that can be employed to remove the antigenic potential of allogeneic cell therapies (e.g. CAR-T) can be used in conjunction with such treatments, but this brings an additional layer of complication.Another difficulty comes from the technical challenges associated with generating, culturing, and expanding the required cells. In theory, any cell type can be derived from pluripotent cells. However, determining precisely how to generate any cell from pluripotent cells is conceptually and practically complex. Each cell type would require a distinct combination of transcription factors (or small molecules) and optimized culture conditions to ensure robust conversion into the desired phenotype. These technical challenges are associated with slow progress and poor efficiency in deriving reliable therapeutic cells.

Mogrify aims to tackle these hurdles with solutions involving big data, computational predictions, and bioinformatics. Mogrifys proprietary algorithm uses next generation sequencing data to predict the combination of transcription factors necessary to reliably convert any cell type into another cell type. Mogrifys technology provides a framework for direct cell conversion, and can also identify the best culture conditions to ensure that the cell populations remain stable and viable. This greatly improves cell therapy efficiency, as mature cells are created without the often arduous and imprecise process of differentiating cells from pluripotency.

Mogrifys technology is also compatible with in vivo cell therapies, as it can identify a combination of small molecules that will drive the necessary transcriptional networks to create the cells of choice. Therefore, Mogrifys technology can also be applied to overcome safety issues associated with allogeneic ex vivo approaches, and has the potential to greatly enhance the scale at which cell therapies can be delivered.MC: Are you able to tell us more about the latest developments in Mogrify's pipeline?JF: Currently, Mogrify is focused on applying the platform to musculoskeletal disorders, cancer immunotherapy, and auto-immune, ocular and respiratory diseases. Specifically, Mogrify is committed to identifying opportunities in regenerative medicine contexts, where direct cell conversion could have strong therapeutic potential.The current lead musculoskeletal program is in the development of chondrocytes for the treatment of cartilage defects and osteoarthritis. Mogrifys platform identified a cocktail of small molecules that successfully drives the conversion of fibroblast cells to chondrocytes, which has been proven to form functional hyaline cartilage in vitro. This can even be performed using an allogeneic approach without the need for gene editing (as the cartilage is immunopriviliged). Thus, it represents an opportunity for an off-the-shelf therapy that could be a relatively inexpensive and accessible treatment. At present, this treatment is in pre-clinical stages, and has a powerful potential for success in regenerative cartilage therapy. Similarly, an in vivo method of transdifferentiating osteoarthritic chondrocytes to healthy cells is being investigated in ongoing studies using a cocktail of small molecules.

Joe Foster, COO, Mogrify was speaking to Molly Campbell, Science Writer, Technology Networks.

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Community resilience is facing Its greatest threat, and colleges are helping | Opinion – pennlive.com

April 16th, 2020 1:45 pm

Throughout history, the nations colleges and universities have set the foundation for innovation and social change. Weve uncovered the secrets of DNA. Weve unleashed bioengineering. We have harnessed intellectual power to create new technologyoften through the partnerships between land grant colleges and local industries and agriculturebringing the latest science to where it was needed. And we have done it all while demanding intellectual rigor and a sharp focus on the common good for society.

At Boston University, the Center for Regenerative Medicine at BUs Medical Center, alerted by colleagues at the University of Washington in Seattle, coordinated with MITs Broad Institute as well as Harvard to produce a test for the virus with a turn around time of within 24 hours. More than 50 volunteered in this round the clock effort. Testing is now underway. Rutgers University has launched its own virus testing program. Its RUCDR Infinite Biologicsa part of the Universitys Human Genetics Institute of New Jerseyis now capable of testing tens of thousands.

Tiny Bay Mills Community College, a Michigan tribal college of fewer than 500 students, has used 3-D technology to design and now produce 1,000 face masks for first responders every week.

Institutions of higher education, large and small, can and do play a significant role in serving our country and our world at this critical moment in history. But our work starts at home. Whats required is a community approach, as local areas are impacted in distinct ways while this crisis unfolds.

I learned the power of community response to overwhelming challenges at the American University of Nigeria. I served there as president when Boko Haram began to surge near the campus and federal assistance was nowhere to be found. The university brought the community together and kept the terrorist group at bay and fed refugees.

Drawing on that experience, when I arrived at Dickinson three years ago, I immediately began to gather with community members to identify their most pressing issues and to connect them with college resources. What started out as a dozen people has now grown to more than 50 representing nearly every sectornonprofits, school districts, health care, government and business. We are meeting remotely in the age of COVID-19, but the relationships we have built have allowed us to respond quickly in a coordinated manner to the communitys growing needs.

Working with Carlisle Borough, the Chamber of Commerce and Community CARES partnered to convert the Stuart Community Center into a shelter for the homeless. UPMC Carlisle anticipated a potential need for housing and shelter for its exhausted medical workers; Dickinson stepped up and agreed to make space available in our vacated residence halls. Local businesses needed an online presence to offer goods and services, but lacked the know-how; Dickinson students are developing e-commerce websites for those businesses. Our organic farm is supplying much-needed fresh produce for the community.

Colleges areand should beat the epicenter of community responses to COVID. They can and should be the assembly point for community action. Its imperative that colleges start building or strengthening relationships with leaders in their communities now, to help in recovery and before the next crisis or disaster occurs.

When students return to class, they will return to communities that have changed in myriad ways. The old ideas, approaches and leadership simply wont do. Our students and young people are the ones we will need to help us with the necessary reconstruction. Those students will rely on the knowledge and problem-solving skills our institutions of higher learning should be providing.

In these difficult times, the country must demand much of its colleges and universities. Communities must know that we are in the trenches with you, and that we are all of us prepared to do more. When students return to our campuses we should work together to build a program of national service. This is how we will rebuild America and prepare the next generation for more unprecedented challenges.

Margee M. Ensign is president of Dickinson College, in Carlisle. Previously, Ensign served as president of the American University of Nigeria, where she developed aid and relief programs for hundreds of thousands of internally displaced people fleeing Boko Haram.

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ACRO Biomedical’s Proprietary Technology Leads the World with Patents from Taiwan, Japan, USA, and Korea – Yahoo Finance

April 16th, 2020 1:45 pm

TAIPEI, April 16, 2020 /PRNewswire/ -- ACRO Biomedical Co., Ltd., the first company in the world to utilize "supercritical CO2 extraction technology" on cleansing animal tissues and organs, is gradually showing impressive results on the global patent map. In 2019, ACRO acquired two patents from Japan. One for the decellularized cartilage graft, and another for the decellularized cornea. The great news continues with ACRO acquiring patents from the USA and Korea successively for the decellularized cornea in March 2020.

ACRO has acquired patents from Taiwan, the USA, Japan, and Korea for the preparation of acellular corneas by utilizing supercritical CO2 extraction technology. Patents from India, EU, Hong Kong, andmainland China are also on their way. The wish to benefit patients around the world with damaged cornea is very promising.

The CEO of ACRO Biomedical, DJ Hsieh, said that the traditional way to utilize supercritical CO2 extraction technology is to extract herbal medicine and essential oil. After many years of research and development, ACRO has successfully utilized the technology on cleansing animal tissues and organs including skin, bone, cartilage, cornea, blood vessel, nerve, heart, kidney, liver, pancreas, and brain. Many of the products have received approval from USFDA, Singapore, Vietnam, Philippines, and Taiwan FDA. Furthermore, ACRO has licensed out Collagen Ophthalmic Matrix to Oculus BioMed from Australia, and also signed an exclusive strategic partnership agreement with Marubeni Corporation from Japan, laying the foundation for the global market.

The advantages of ACRO's technology application are its high efficiency, low cost, time-saving, and when compared with other products of the same type that are decellularized with acid-base solutions or organic solvents, it greatly reduces the chance of allergy and immune rejection. It is a great help for the future development of the global regenerative medicine.

SOURCE ACRO Biomedical Co., Ltd.

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New England Journal of Medicine Publishes Pivotal Results Evaluating Sunovion’s SEP-363856 for the Treatment of Schizophrenia – PharmaLive

April 16th, 2020 1:45 pm

In this study, once-daily, flexible-dose (50-75 mg) treatment with SEP-363856 demonstrated a statistically significant and clinically meaningful improvement in the Positive and Negative Syndrome Scale (PANSS) total score compared to placebo after four weeks of treatment (-17.2 vs. -9.7, respectively; p=0.001). Patients treated with SEP-363856 also showed improvement in the overall severity of illness as assessed by the Clinical Global Impression Scale Severity (CGI-S) (p<0.001). In addition, improvement was observed in all major PANSS (positive, negative and general psychopathology) subscales (p<0.02). SEP-363856 was well tolerated throughout the study and the overall discontinuation rate was comparable for SEP-363856 and placebo.1

These data represent an exciting step forward in schizophrenia research. The steps that led to identifying this new mechanism of action, targeting TAAR1, were very novel and they reflected a courageous and innovative approach by Sunovion to identifying new ways to treat schizophrenia, said John Krystal, M.D., Chair of Psychiatry and Co-Director, Yale Center for Clinical Investigation at Yale School of Medicine and co-author of the NEJM publication. For the last 60 years, antipsychotics that bind to dopamine receptors have been the standard of care, despite their side effect profile. It is my hope that these results for SEP-363856 support a new schizophrenia treatment for people who have been diagnosed with this serious mental health condition. SEP-363856 could have a big impact on people with schizophrenia, their families, and on the public health burden posed by schizophrenia.

SEP-363856 is a novel trace amine-associated receptor 1 (TAAR1) agonist with serotonin 1A (5-HT1A) agonist activity that is being evaluated in patients with schizophrenia. SEP-363856 does not bind to dopamine 2 (D2) or serotonin 2A (5-HT2A) receptors, which are thought to mediate the effects of currently available atypical antipsychotic medicines. SEP-363856 is being studied in the DIAMOND (Developing Innovative Approaches for Mental Disorders) Phase 3 global development program for schizophrenia with additional indications under consideration. The U.S. FDA granted Breakthrough Therapy Designation for SEP-363856 for the treatment of schizophrenia in May 2019.

Publication of these findings in the New England Journal of Medicine demonstrates the potential of SEP-363856 to be the first TAAR1 agonist for the treatment of schizophrenia, said Kenneth Koblan, PhD, Chief Scientific Officer of Sunovion. This innovative approach to the treatment of schizophrenia may provide a completely new option for the 23 million people worldwide who live with this serious mental health condition. Sunovion is committed to developing new treatment options for these patients and continuing to study SEP-363856 to further evaluate its clinical benefit in schizophrenia and other neuropsychiatric conditions.

As noted in the NEJM publication, in the six-month, open-label extension study, SEP-363856 demonstrated continued improvement across efficacy measures, including the PANSS total score, the CGI-S score, and the Brief Negative Symptom Scale (BNSS) total score and appeared to be safe and well-tolerated.

About SEP-363856 SEP-363856 is a TAAR1 agonist with 5-HT1A agonist activity that is under investigation for the treatment of schizophrenia and other psychiatric conditions. Sunovion discovered SEP-363856 in collaboration with PsychoGenics based in part on a mechanism-independent approach using the in vivo phenotypic SmartCube platform and associated artificial intelligence algorithms. SEP-363856 is being studied in a global Phase 3 development program for schizophrenia (DIAMOND) with additional indications under consideration. The U.S. FDA granted Breakthrough Therapy Designation for SEP-363856 for schizophrenia in May 2019.

About Schizophrenia Schizophrenia is a chronic, serious and often severely disabling brain disorder that affects more than 23 million people worldwide2 and approximately one in 100 adults (about 2.4 million people) in the United States.3 It is characterized by positive symptoms, such as hallucinations, delusions and disorganized thinking as well as negative symptoms, such as lack of emotion, social withdrawal, lack of spontaneity and cognitive impairment that includes problems with memory, attention and the ability to plan, organize and make decisions.2

About Sunovion Pharmaceuticals Inc. (Sunovion) Sunovion is a global biopharmaceutical company focused on the innovative application of science and medicine to help people with serious medical conditions. Sunovions vision is to lead the way to a healthier world. The companys spirit of innovation is driven by the conviction that scientific excellence paired with meaningful advocacy and relevant education can improve lives. With patients at the center of everything it does, Sunovion has charted new paths to life-transforming treatments that reflect ongoing investments in research and development and an unwavering commitment to support people with psychiatric, neurological and respiratory conditions.

Headquartered in Marlborough, Mass., Sunovion is an indirect, wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Sunovion Pharmaceuticals Europe Ltd., based in London, England, and Sunovion Pharmaceuticals Canada Inc., based in Mississauga, Ontario, are wholly-owned direct subsidiaries of Sunovion Pharmaceuticals Inc. Additional information can be found on the companys websites: http://www.sunovion.com, http://www.sunovion.eu and http://www.sunovion.ca. Connect with Sunovion on Twitter, LinkedIn, Facebook and YouTube.

About Sumitomo Dainippon Pharma Co., Ltd. Sumitomo Dainippon Pharma is among the top-10 listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the U.S., China, and the European Union. Sumitomo Dainippon Pharma aims to create innovative pharmaceutical products in the Psychiatry & Neurology area, the Oncology area and Regenerative medicine/Cell therapy field, which have been designated as the focus therapeutic areas. Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more than 6,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at https://www.ds-pharma.com.

SUNOVION is a registered trademark of Sumitomo Dainippon Pharma Co., Ltd.

Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Dainippon Pharma Co., Ltd. 2020 Sunovion Pharmaceuticals Inc. All rights reserved.

For a copy of this release, visit Sunovions website at http://www.sunovion.com

References

1 Koblan, K., Kent, J., Hopkins, S., Krystal, J., Cheng, H., Goldman, R., Loebel, A., A non-D2 Binding Drug for the Treatment of Schizophrenia. New England Journal of Medicine. April 16, 2020, Vol. 382, Issue 16, p. 1497-1506. Available online: https://www.nejm.org/doi/full/10.1056/NEJMoa1911772. Accessed April 2020. 2 World Health Organization. Mental Disorders. [Internet]. Available from:https://www.who.int/news-room/fact-sheets/detail/mental-disorders. Accessed September 2018. 3 National Institute of Mental Health. Schizophrenia. [Internet]. Available from: https://www.nimh.nih.gov/health/topics/schizophrenia/index.shtml. Accessed September 2018.

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Global Regenerative Medicine Market : Industry Analysis and Forecast (2019-2026): By Type, Application and Region. – Publicist360

April 16th, 2020 1:45 pm

Global Regenerative Medicine Marketwas valued US$ XX Bn in 2018 and is expected to reach US$ XX Bn by 2026, at a XX %CAGR of around 24.3% during a forecast period.

Regenerative medicine is an interdisciplinary field of medicine that is used for developing methods to grow, replace or repair diseased or damaged cells, organs, and tissues. Regenerative medicine contains the generation and use of therapeutic stem cells, tissue engineering and the production of artificial organs.

The report covers all the trends and technologies playing a major role in the growth of the regenerative medicine market over the forecast period. It highlights the drivers, restraints, and opportunities expected to influence market growth during 2019-2026.

Global Regenerative Medicine Market

Regenerative medicines are expected to have a major impact on healthcare to treat specific indications and chronic conditions. Therefore, a high prevalence of cancer, neurodegenerative, orthopedic, and other ageing-associated disorders coupled with increasing worldwide geriatric population is driving the market growth. Additionally, increasing prevalence of inheritable genetic diseases is anticipated to fuel the demand in the field of the biotechnology field. However, high treatment costs, operative inefficiency, stringent government regulations, and lack of awareness will restrict the global market for regenerative medicine.

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The report on global regenerative medicine market covers segments such as type, application and region. Based on application, oncology segment is estimated to witness the fastest XX% CAGR over the forecast period. Many government organizations, as well as private companies, have made high investments in cancer research and development of regenerative & advanced cell therapies. Global efforts to reduce the cancer burden is expected to support the lucrative growth of the oncology segment.North America is the dominating region in the market for regenerative medicine. The major factors promoting regenerative medicine market growth in this region are growing awareness for the use of these medicines to treat various diseases and rising funding line for developing the product line by the private and government organizations.

However, the APAC is considered to grow at a faster rate during the forecast period because of the increasing focus on research and development on regenerative medicine, various government have taken initiative to treat many diseases with the help of regenerative medicines. The report gives a recent development in the market for regenerative medicine like in 2018, Novartis AG received EU approval for one-time gene therapy Luxturna, which has been developed to restore visualization in people with rare and genetically-associated retinal disease. Additionally, in 2017, Integra LifeSciences launched its product, Integra Dermal Regeneration Template Single Layer Thin for dermal repair faults reconstruction in a one-step procedure.

The objective of the report is to present a comprehensive assessment of the market and contains thoughtful insights, facts, historical data, industry-validated market data and projections with a suitable set of assumptions and methodology. The report also helps in understanding Global Regenerative Medicine Market dynamics, structure by identifying and analyzing the market segments and project the global market size. Further, the report also focuses on the competitive analysis of key players by product, price, financial position, product portfolio, growth strategies, and regional presence. The report also provides PEST analysis, PORTERs analysis, and SWOT analysis to address the question of shareholders to prioritizing the efforts and investment shortly to the emerging segment in the Global Regenerative Medicine Market.Scope of the Global Regenerative Medicine Market

DO INQUIRY BEFORE PURCHASING REPORT HERE:https://www.maximizemarketresearch.com/inquiry-before-buying/35229/

Global Regenerative Medicine Market, By Type

Cell-Based Immunotherapy & Cell Therapy Productso Allogeneic Productso Autologous Products Tissue-Engineered Products Gene Therapy ProductsGlobal Regenerative Medicine Market, By Application

Musculoskeletal Disorders Wound Care Oncology Ocular Disorders Diabetes OtherGlobal Regenerative Medicine Market, By Region

North America Europe Asia Pacific Middle East & Africa South AmericaKey Players operating in the Global Regenerative Medicine Market

Integra LifeSciences Corporation Astellas Pharma Inc. Ocata Therapeutics, Inc. Corline Biomedical AB Cook Biotech, Inc. Bayer BV BlueRock Therapeutics AstraZeneca MedImmune F. Hoffmann-La Roche Ltd Pfizer Inc. Merck & Co., Inc. Sigma-Aldrich Co. LLC Abbott St. Jude Medical, Inc. Vericel Corporation Novartis AG Alcon GlaxoSmithKline plc. Baxter. Synovis Micro Companies Alliance Inc Amgen Inc. Eli Lilly and Company Bristol-Myers Squibb Company iPierian, Inc Nuvasive, Inc. Organogenesis, Inc. NuTech MiMedx Group, Inc. Stability, LLC. Takara Bio Inc. Caladrius Biosciences, Inc. U.S. Stem Cell, Inc. Cesca Therapeutics Osiris Therapeutics, Inc

MAJOR TOC OF THE REPORT

Chapter One: Regenerative Medicine Market Overview

Chapter Two: Manufacturers Profiles

Chapter Three: Global Regenerative Medicine Market Competition, by Players

Chapter Four: Global Regenerative Medicine Market Size by Regions

Chapter Five: North America Regenerative Medicine Revenue by Countries

Chapter Six: Europe Regenerative Medicine Revenue by Countries

Chapter Seven: Asia-Pacific Regenerative Medicine Revenue by Countries

Chapter Eight: South America Regenerative Medicine Revenue by Countries

Chapter Nine: Middle East and Africa Revenue Regenerative Medicine by Countries

Chapter Ten: Global Regenerative Medicine Market Segment by Type

Chapter Eleven: Global Regenerative Medicine Market Segment by Application

Chapter Twelve: Global Regenerative Medicine Market Size Forecast (2019-2026)

Browse Full Report with Facts and Figures of Regenerative Medicine Market Report at:https://www.maximizemarketresearch.com/market-report/global-regenerative-medicine-market/35229/

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Global Regenerative Medicine Market : Industry Analysis and Forecast (2019-2026): By Type, Application and Region. - Publicist360

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Hot Stock in the Spotlight:: China Regenerative Medicine International Limited (HKSE:8158) – Investor Welcome

April 16th, 2020 1:45 pm

China Regenerative Medicine International Limited (HKSE:8158) STOCK IN FOCUS:

Overbought and Oversold levels

The stock has RSI reading of 53.08. RSI gives an indication of the impending reversals or reaction in price of a security. RSI moves in the range of 0 and 100. So an RSI of 0 means that the stock price has fallen in all of the 14 trading days. Similarly, an RSI of 100 means that the stock price has risen in all of the 14 trading days. In technical analysis, an RSI of above 70 is considered an overbought area while an RSI of less than 30 is considered as an oversold area. RSI can be used as a leading indicator as it normally tops and bottoms ahead of the market, thereby indicating an imminent correction in the price of a security. It is pertinent to note that the levels of 70 and 30 needs to be adjusted according to the inherent volatility of the security in question.

If you are considering getting into the day trading or stock market, its a legitimate and profitable method for making a living. Every good investor knows that in order to make money on any investment, you must first understand all aspects of it, so lets look at daily change, stock price movement in some particular time frame, volatility update, performance indicators and technical analysis and analyst rating. Picking a stock is very difficult job. There are many factors to consider before choosing a right stock to invest in it. If picking stock was easy, everyone would be rich right? This piece of financial article provides a short snap of China Regenerative Medicine International Limited regarding latest trading session and presents some other indicators that can help you to support yours research about China Regenerative Medicine International Limited.

China Regenerative Medicine International Limited (HKSE:8158) stock Trading Summary:

China Regenerative Medicine International Limited (HKSE:8158) stock changed position at +1.92%% to closing price of HKD$0.265 in recent trading session. The last closing price represents the price at which the last trade occurred. The last price is also the price on which most charts are based; the chart updates with each change of the last price. The stock registered Last trading volume of 426750 shares. Daily volume is the number of shares that are traded during one trading day. High volume is an indication that a stock is actively traded, and low volume is an indication that a stock is less actively traded. Some stocks tend always to have high volume, as they are popular among day traders and investors alike. Other stocks tend always to have low volume, and arent of particular interest to short-term traders. The stock average trading capacity stands with 1.648M shares and relative volume is now at 0.26 .

China Regenerative Medicine International Limited (HKSE:8158) Stock Price Movement in past 50 Days period and 52-Week period

China Regenerative Medicine International Limited stock demonstrated 12-month low at HKD$0-39.62% and unveiled a 12-month high of HKD$1+239.62%. Prices of commodities, securities and stocks fluctuate frequently, recording highest and lowest figures at different points of time in the market. A figure recorded as the highest/lowest price of the security, bond or stock over the period of past 52 weeks is generally referred to as its 52-week high/ low. It is an important parameter for investors (as they compare the current trading price of the stocks and bonds to the highest/lowest prices they have reached in the past 52 weeks) in making investment decisions. It also plays an important role in determination of the predicted future prices of the stock.

China Regenerative Medicine International Limited (HKSE:8158) Stock Past Performance

China Regenerative Medicine International Limited stock revealed 0.06% return for the recent month and disclosed 0.1522% return in 3-month period. The stock grabbed -0.9732% return over five years and -0.47% return in yearly time period. Past performance shows you the funds track record, but do remember that past performance is not an indication of future performance. Read the historical performance of the stock critically and make sure to take into account both long- and short-term performance. Past performance is just one piece of the puzzle when evaluating investments. Understanding how performance fits in with your overall investing strategy and what else should be considered can keep you from developing tunnel vision.

Volatility in Focus:

The stock unfolded Volatility or average true range percent (ATRP 14) at 0.0507%. Volatility is a rate at which the price of a security increases or decreases for a given set of returns. Average true range percent (ATRP) measures volatility on a relative level. This is opposed to the ATR, which measures volatility on an absolute level. ATRP allows securities to be compared whereas ATR does not. That means lower-priced stocks wont necessarily have lower ATR values than higher priced stocks.

Beta factor is now at 0.86. BETA indicates whether a stock is more or less volatile than the market as a whole. A stock that has a beta score higher than 1 means that volatility is high, while less than 1 means that volatility is low.

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Hot Stock in the Spotlight:: China Regenerative Medicine International Limited (HKSE:8158) - Investor Welcome

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COLUMN Worried about your immune system? Try these 5 natural remedies – Body aches fever chills and nasal congestion common symptoms of the flu can…

April 16th, 2020 1:45 pm

San Diego Community News Group

Complications arising from these illnesses can become serious, says Dr. Suhyun An (drsuhyunan.com), an expert on regenerative medicine and co-author of Demystifying Stem Cells: A Real-Life Approach To Regenerative Medicine.

An says there are ways to prevent the symptoms from reaching that serious point. To feel better and get back on your feet, she recommends numerous natural cold and flu remedies to alleviate your symptoms:

Vitamin C. Some studies indicate that vitamin C can shorten the lifespan of a cold and boost your immune system. The best way to get it is through your diet; the fresher the food, the better, An says. Oranges, limes, lemons, grapefruits, leafy greens, and bell peppers are all good sources of vitamin C. Be careful with supplements because they can lead to upset stomach and kidney stones.

Honey. Honey has natural antiviral and antimicrobial properties. Drinking honey in tea with lemon can ease sore throat pain, An says. Research suggests that honey is an effective cough suppressant, too. Honey often contains Clostridium bacteria, so never give honey to a child younger than 1-year-old because infants immune systems arent able to fight them off.

Chicken soup. This popular cold and flu remedy helps because hot liquids reduce mucus buildup and keep you hydrated. Chicken soup, in particular, has anti-inflammatory properties, which help reduce a colds unpleasant side effects, An says. Keep some in the freezer or even canned for flu season. Its quick to prepare that way and soothing to eat.

Aromas. When you have congestion from the flu, applying camphor or menthol salve around your nose can help break up mucus, An says. Aromatherapy oils, such as peppermint and eucalyptus, can have a similar effect. Also, vapor rub can reduce cold symptoms, especially in children older than 2 years. It helps open air passages to combat congestion, reduce coughing, and improve sleep. Its a good alternative to over-the-counter cold medicines in young children because of unwanted side effects.

Probiotics. These are friendly bacteria and yeast found in the body, some foods, and supplements. They can help keep your gut and immune system healthy, and they may reduce your chance of getting sick with an upper respiratory infection, An says. For a delicious and nutritious source of helpful bacteria, include probiotic yogurt in your diet.

Colds and the flu are threats to us every year, but they dont have to get us down for long, An says. Natural home remedies can reduce symptoms so you can be more comfortable and get the rest you need to get better faster.

Dr. Suhyun An is the clinic director at Campbell Medical Group in Houston and an expert on regenerative medicine.

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COLUMN Worried about your immune system? Try these 5 natural remedies - Body aches fever chills and nasal congestion common symptoms of the flu can...

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Stem Cell Therapy Clinic Still Evaluating Patients But with Precautions During Covid Closures – Press Release – Digital Journal

April 16th, 2020 1:43 pm

Denver Regenerative Medicine | Stem Cell Therapy, HRT, Testosterone Clinic, which is based in Denver, Colorado, has announced that they continue to evaluate patients but with the necessary precautions during the Covid closures. They realized that there could be people with back pain who cant wait for the quarantine to be over. For those who are looking for pain relief during this time, they can still schedule an appointment for back pain, and the clinic can still offer procedures as they are necessary medical care.

Dr. Joel Cherdack of Denver Regenerative Medicine says, If you feel that your back pain cant wait until the quarantine is over, dont hesitate to contact us. Well be taking all of the necessary precautions to avoid the spread of the virus but well be ready to serve your needs.

He continues, There are many advantages to stem cell therapy at our Denver Regenerative medicine clinic over surgery including faster recovery, less pain, lower cost, decreased or eliminated need to immobilize with a sling or cast and other benefits as well. Before any procedure takes place, we will meet with you for an initial consultation to evaluate your injuries and determine the best stem cell injection options for you.

Stem cells are extracted from the body of the patient and may be used to treat pain through the regeneration of damaged tissue. These cells are self-renewing and can grow into any kind of cell required by the body. Because stem cells from the patient are used to establish a customized treatment plan, there is less risk of the body rejecting the cells and can enhance the bodys own natural rejuvenating abilities.

The stem cell therapy procedure has three basic steps. First, the stem cells are extracted from bone marrow, body fat, or other tissue. Second, the stem cells are conditioned to maximize their healing capability. And third, the stem cells are injected into the area where they can have their maximum effect. Denver Regenerative Medicine utilizes stem cell therapy for the treatment of the deterioration of the joints of the elbows, knees, hips, and shoulders and to enhance the healing of soft tissues. Those who would like to know more about stem cell therapy and the clinic may want to follow the Denver Regenerative Medicine Facebook page.

Meanwhile, hormone replacement therapy (HRT) is offered for hormone imbalance problems. For men, HRT may be able to combat a number of symptoms, such as reduced interest in sex, erectile dysfunction, lower muscle mass and increased body fat, fatigue, loss of body and facial hair, and depression and cognitive issues. For women, HRT may be able to deal with a number of issues, such as thinning hair; irregular menstrual cycles; painful or unusually heavy periods; weight gain; increased growth of hair on the face, chest, neck, or back; hot flashes; and vaginal dryness.

Also available is the REjuvenate Therapy (for Men & Women), which is a combination of stem cell therapy and hormone replacement therapy. The combination results in a synergy between the two treatments to fight the illnesses caused by hormone imbalance, which could be the result of toxins, stress, and other natural factors.

Denver Regenerative Medicine also offers the unique AcCELLerate Stem Cell regeneration system. It combines the patients own stem cells and platelet rich plasma (PRP) for a combination of activated stem cells and platelets. This combination allows all of the growth factors from the PRP to immediately activate the stem cells. Patients who received this combination of stem cells and activated platelets noticed results about 30 percent faster compared to those who only received stem cells. Furthermore, the improvement was sustained over a longer period for the patients who received the AcCELLerate Stem Cell therapy.

Those who are interested in stem cell therapy and the other therapies available at Denver Regenerative Medicine | Stem Cell Therapy, HRT, Testosterone Clinic may want to check out their website at https://denverregenerativemedicine.com/, or contact them on the telephone, or through email. They are open from 10:00 am to 6:00 pm on Mondays, and from 8:00 am to 6:00 pm, from Tuesday to Thursday.

###

For more information about Denver Regenerative Medicine | Stem Cell Therapy, HRT, Testosterone Clinic, contact the company here:

Denver Regenerative Medicine | Stem Cell Therapy, HRT, Testosterone ClinicDr. Joel Cherdack(720) 583-1648info@denverregenerativemedicine.comDenver Regenerative Medicine | Stem Cell Therapy, HRT, Testosterone Clinic2149 S Holly St #200Denver, CO 80222

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Stem Cell Therapy Clinic Still Evaluating Patients But with Precautions During Covid Closures - Press Release - Digital Journal

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Vanda Pharmaceuticals Announces Initiation of "CALYPSO" to Study the Role of Genetic Variation in COVID-19 Infections in Collaboration With…

April 16th, 2020 1:42 pm

WASHINGTON, April 15, 2020 /PRNewswire/ --Vanda Pharmaceuticals, Inc.(Vanda) (Nasdaq: VNDA) today announced the initiation of the CALYPSO program to study the role that human genetic variations play in SARS-CoV-2 ("COVID-19") infection and disease progression. As a part of the CALYPSO program, Vanda will collaborate with University of Washington School of Medicine and its Virology Lab on a pharmacogenetics study in patients with COVID-19. The study will focus on the sequencing of the genome of individual patients, as well as the COVID-19 virus, and the identification of genetic factors that correlate with disease progression and outcomes.

In support of this study, Vanda and UW Medicine plan to collect Whole-Genome Sequencing ("WGS") data from over 1,000 patients with COVID-19 infection, and perform Viral Genome Sequencing, which should enable Vanda and the UW Medicine Virology Lab to explore host susceptibility, associations of WGS with clinical outcomes and severity of disease, as well as host-virus interactions. The study is scheduled to begin enrollment in the coming weeks and will be open to patients in hospitals and clinics around the United States.

"We look forward to the advancement of our program and the opportunity to work with and leverage the expertise of UW Medicine to expand our understanding of the COVID-19 infection mechanism," said Mihael H. Polymeropoulos, M.D., President and Chief Executive Officer of Vanda.

"The study has the potential to provide new insights into virushost interactions that could lead to more effective public health strategies and the design and development of vaccines and therapeutics," said Sandra P. Smieszek, Ph.D., Head of Genetics at Vanda. "With the vast amount of data we expect to collect, the team will aim to discern the factors associated with severity and other critical, clinical characteristics of the infected individuals."

"By leveraging our sequencing expertise and capabilities in collaboration with Vanda, we will be able to provide the necessary insight for potentially life-saving solutions for patients," said Alex Greninger M.D., Ph.D., M.S., M.Phil., Assistant Professor, Laboratory Medicine, Assistant Director, Virology Division at the University of Washington School of Medicine. "We believe this collaboration will help answer critical questions and hopefully outcomes in the fight against COVID-19."

"We are grateful to collaborate with Vanda as we try to find better ways to care for people currently suffering from COVID-19, and as we develop plans for the next phase of the national response," said Keith R. Jerome, M.D., Ph.D., Head of Virology Division at the University of Washington School of Medicine. "The approach of combining host and viral genomics to identify the most promising treatments may serve as a model for future efforts around the world. This unique agreement positions UW Medicine and Vanda for potentially changing the course of the COVID-19 pandemic."

"This is the type of collaboration we need to bring solutions to patients suffering in this time of crisis," said Dr. Greninger. "We look forward to getting this important work underway."

About Vanda Pharmaceuticals Inc.

Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit http://www.vandapharma.com and follow us on Vanda's Twitter and LinkedIn.

About UW Virology

The UW Virology is one of nine divisions comprising the Department of Laboratory Medicine at the University of Washington School of Medicine. The UW Medicine Virology Clinical Laboratories perform diagnostic testing for a full range of human pathogens including respiratory viruses, herpes group viruses, HIV, hepatitis, and enteric viruses, and was one of the earliest providers of COVID-19 testing. The Division provides the highest quality patient care and serves as a model of excellence for clinical laboratories across the nation. Its UW Virology Lab is also recognized as a worldwide leader in virology research. UW Medicine Virology's research programs integrate the latest in computational, laboratory, and clinical research methods to advance the understanding of infectious diseases. Many past and current faculty members in the Virology Division have received prestigious awards recognizing their scientific achievements.

Vanda Contact:

AJ Jones IIChief Corporate Affairs and Communications OfficerVanda Pharmaceuticals Inc.202-734-3400

pr@vandapharma.com

UW Medicine Contact:

Susan GreggDirector, Media Relations206-616-6730

sghanson@uw.edu

CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS

Various statements in this release are "forward-looking statements" under the securities laws. These forward-looking statements include, without limitation, statements regarding the design, enrollment and anticipated findings of the CALYPSO program, the promotion of more effective public health strategies and the design and development of vaccines and therapeutics. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others: Vanda's ability to enroll patients for, and successfully conduct, the study described in this press release; the ability of Vanda, either alone or with its partners, to process the data collected and subsequently develop effective vaccines or therapeutics; the ability to obtain FDA approval of any such vaccines or therapeutics; and other factors that are set forth in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's annual report on Form 10-K for the fiscal year ended December 31, 2019, which is on file with the SEC and available on the SEC's website at http://www.sec.gov. Additional factors may be set forth in those sections of Vanda's annual report on Form 10-Q for the fiscal quarter ended March 31, 2020, to be filed with the SEC in the second quarter of 2020. In addition to the risks described above and in Vanda's annual report on Form 10-K and quarterly reports on Form 10-Q, other unknown or unpredictable factors also could affect Vanda's results. There can be no assurance that the actual results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved. All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this release is provided only as of the date of this release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

View original content:http://www.prnewswire.com/news-releases/vanda-pharmaceuticals-announces-initiation-of-calypso-to-study-the-role-of-genetic-variation-in-covid-19-infections-in-collaboration-with-university-of-washington-medicine-301041400.html

SOURCE Vanda Pharmaceuticals Inc.

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Vanda Pharmaceuticals Announces Initiation of "CALYPSO" to Study the Role of Genetic Variation in COVID-19 Infections in Collaboration With...

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Antibody testing: The promise and pitfalls of using them to reopen the US – PolitiFact

April 16th, 2020 1:42 pm

As Americans yearn for a future with work, shopping and outings with friends, one concept may become a crucial prerequisite: the widespread use of antibody tests.

Antibody tests, also known as serology tests, are designed to detect the presence of antibodies proteins that are key elements of the bodys immune response to germs. Antibodies would be present in people who battled the coronavirus and recovered, as well as in people who had been exposed but whose infection was so mild that they didnt notice they were sick.

If someone has antibodies from exposure to the coronavirus, that person should have immunity to the virus, at least for a period of time. (More on that in a bit.) That means they can go out into the wider community without fear of getting sick themselves. Antibody tests could also be helpful for making staffing decisions in medical units treating coronavirus patients.

Anthony Fauci, a top federal official in the fight against the coronavirus, has floated the idea of "immunity certificates" based on antibody testing. "As we get to the point of considering opening the country, it is very important to understand how much that virus has penetrated society," Fauci said on CNN.

Its also a key element of Democratic presidential candidate Joe Bidens plan for reopening the country. And New York Gov. Andrew Cuomo has gone so far as to develop and start implementing an antibody testing system for New York State. "We cannot restart life as we knew it without testing," Cuomo has tweeted.

PolitiFact interviewed several experts about the promise and potential pitfalls of antibody testing.

What has been done so far?

The Food and Drug Administration has already granted an "emergency use authorization" for one particular antibody test manufactured by a company called Cellex. The FDA also green-lighted other tests for the market without the usual review process, as long as they are labeled with disclaimers that the agency has not fully reviewed them.

That enabled more than 90 tests to go to market, some from academic organizations and some from medical companies, according to Politico. The CDC itself is working to produce one. Researchers at Stanford University have produced one test, while Mount Sinais Icahn School of Medicine has produced another.

The key to developing antibody tests is to have an appropriate coronavirus protein, "because thats what antibodies recognize," said Elizabeth McNally, director of the Center for Genetic Medicine at Northwestern Universitys Feinberg School of Medicine.

The tests work by having some viral protein adhered to a surface, McNally said. "A persons blood sample is mixed with a virus protein and is tested for whether there is an interaction between antibodies in the persons blood and the antibody on the surface."

The good news is that many of the tests are not overly complicated, often requiring blood from a self-administered finger prick. Some have a turnaround time as rapid as 10 to 15 minutes.

How accurate are these antibody tests?

Thats the bad news: The tests so far have not been especially accurate.

In mid April, the FDA said the National Cancer Institute would start reviewing tests for accuracy. This move was welcomed by medical experts.

The United Kingdom has already pulled some tests for inaccuracy. Many antibody tests now being rolled out "may not be as accurate as wed like," FDA commissioner Stephen Hahn has acknowledged. Scott Becker, CEO of the Association of Public Health Laboratories, went so far as to label many of the tests "crappy," CNN reported.

"There is very limited data, almost none peer-reviewed, evaluating how well these tests perform," said Elitza S. Theel, director of the infectious diseases serology laboratory at the Mayo Clinic. "So its critical that laboratories carefully perform validation and verification studies to ensure that the test they are offering for clinical testing is accurate."

A key metric will be a tests "sensitivity," which refers to the percentage of positive tests that reflect genuine infections. "Anything less than 99% would mean too many cases in the population are wrongly identified, throwing off population estimates," said Theo Vos, a professor at the University of Washingtons Institute for Health Metrics and Evaluation.

Will antibodies actually confer immunity?

Scientists expect that a past infection will produce some immunity. But they arent entirely certain of it, and it remains unclear how long that immunity could last.

Generally speaking, the degree and duration of immunity from an infection varies depending on the germ in question. Immunity from common cold viruses last a few weeks; immunity from chickenpox can last decades. Many infectious diseases fall somewhere in between.

One hopeful sign is that an infection with the virus that causes SARS, which is similar to COVID-19, produces an antibody response for a year, maybe more. Thats not as long as some diseases, but it could buy time until a successful vaccine is produced, which experts say could happen within 12 to 18 months.

One unknown is whether that immune response from a past coronavirus infection is strong enough to actually preclude a new infection.

COVID-19 probably gives immunity to "most people, but we dont know for sure that is the case in every recovered COVID patient," said Angela Rasmussen, associate research scientist at the Center for Infection and Immunity at the Columbia University Mailman School of Public Health. "We dont know what levels of antibodies confer protection either, so we should not assume that just having antibodies guarantees that you have completely protective immunity. Theres still a lot more to learn."

What are some of the practical challenges of administering tests?

One practical concern is when to collect samples from individuals.

"We know it takes over a week in some cases to mount an immune response to the virus and to develop a detectable level of antibodies," Theel said. "The samples need to be collected at a certain time after symptom onset. Using samples collected too soon would lead to negative results simply because the patient hasnt developed an immune response to the virus yet."

By the same token, additional testing may be necessary to confirm that someone who is antibody-positive is no longer experiencing an active infection that can get others sick.

Another practical issue is where the test should be administered.

"We dont want to have people rushing to a doctors office or a hospital since that could actually worsen the spread of the virus," McNally said. "Some companies are producing small individual test kits which will produce a + or - result. Some of these tests will require a doctors order and some may become commercially available."

For instance, McNallys institution, Northwestern University, is developing a kit that is designed to be sent through the mail. Once returned via mail with a blood drop on specially treated paper, the tested individual can find out their result a few days later through a secure website.

What can antibody testing tell us about society at large, rather than just the individual?

Knowing how many people are immune will be a key element of the decision to reopen the economy. However, undertaking society-wide testing will require coordinated effort.

Already, some studies are under way. The World Health Organization is working on a study of a half-dozen nations, while one effort in the U.S. is already collecting blood samples in such cities as New York, Seattle and Minneapolis. Other studies are occurring in Michigan, Miami and Los Angeles.

One study completed in a hard-hit town in Germany recently found that 14% of those tested had antibodies to coronavirus.

McNally said research studies like these are important because they "allow us to be able to know how the population has developed immunity. We will want to know what percentage of the population has developed antibodies and how this differs across neighborhoods and areas. This is the type of information that will help to guide decisions about bringing people back to work and future safety issues."

What needs to be done to enable large-scale antibody testing?

Vos recommends focusing on a small number of the most promising tests, then scaling up production. The expected high demand for antibody tests should help push companies to do this quickly, he said. In the meantime, he said, poorly performing tests should be restricted and the FDA should accelerate its regulatory process.

"Things are happening quickly, but without strong oversight there will be a flood of undocumented tests in use, muddying the waters for anyone trying to make sense of what is going on in the community," Vos said.

Its also important to note that antibody tests are just one part of whats needed to restart the economy. Experts say it will also require a system of widely available diagnostic tests to determine if someone has an active coronavirus infection, along with "contact tracing," a method of identifying people who were in close proximity to other people who were infected, so that they can be tested and, if necessary, quarantined.

CDC director Robert R. Redfield told NBC News that large-scale antibody testing could fall into place "over the next several months."

McNally told PolitiFact that she expects antibody testing to be ramping up in May.

"We know most people take about four weeks to develop antibodies and immunity, so assuming exposure to the virus occurred in March or April, we really want testing working at scale in May," she said. "I think were on target for that."

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Antibody testing: The promise and pitfalls of using them to reopen the US - PolitiFact

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Axovant Announces Partnership with Invitae to Increase Access to Genetic Testing and Accelerate Diagnoses of GM1 and GM2 Gangliosidosis – Yahoo…

April 16th, 2020 1:42 pm

NEW YORK and BASEL, Switzerland, April 15, 2020 (GLOBE NEWSWIRE) -- Axovant Gene Therapies Ltd., a clinical-stage company developing innovative gene therapies for neurological diseases, today announced its collaboration with Invitae, a leading medical genetics company, in the Detect Lysosomal Storage Diseases (Detect) program to facilitate faster diagnoses for children with lysosomal storage disorders (LSDs), including GM1 gangliosidosis and GM2 gangliosidosis, also known as Tay-Sachs/Sandhoff disease. Invitae offers genetic testing and counseling at no charge to patients suspected of having an LSD.

Axovant is committed to developing novel gene therapies for those living with rapidly progressive neurodegenerative diseases. We are hopeful that our collaboration with Invitae will provide families with easier access to genetic testing and bring us one step closer to identifying patients who may benefit from potential therapies, said Parag Meswani, PharmD., Axovants SVP of Commercial Strategy & Operations. Our AXO-AAV-GM1 clinical program targeting GM1 gangliosidosis is currently enrolling at the National Institutes of Health, and we are seeking IND clearance for the AXO-AAV-GM2 clinical trial targeting Tay-Sachs and Sandhoff diseases. Early intervention is ideal with potentially disease-modifying genetic therapies, and our diagnostics partnership with Invitae should allow us to identify and enroll children at even earlier stages of disease progression.

LSDs are progressive, multi-system, inherited metabolic diseases associated with premature death, and genetic testing is a crucial first step to arriving at a diagnosis. LSDs are misdiagnosed or undiagnosed in the majority of patients. The Detect program includes a specific LSD testing panel of 53 genes designed to provide patients and families accurate information quickly to preserve valuable treatment time.

Genetic testing can expedite an accurate diagnosis, facilitate earlier interventions, allow genetic counseling of family members, and support clinical research for LSDs such as GM1 and GM2 gangliosidosis, said Robert Nussbaum, M.D., chief medical officer of Invitae. Were pleased Axovant has joined the Detect program to help offer no-charge, sponsored genetic testing for those patients suspected of having the disease.

Research has shown no-charge testing programs with large well-designed panels help increase utilization of genetic testing, which can shorten the time to diagnosis by as much as 2 years in some conditions. Accurate diagnoses enable clinicians to focus on providing disease-specific care sooner, helping reduce costs and improve outcomes.

Additional details, as well as terms and conditions of the program, can be found at https://www.invitae.com/en/detectLSDs/.

About Axovant Gene Therapies

Axovant Gene Therapies is a clinical-stage gene therapy company focused on developing a pipeline of innovative product candidates for debilitating neurodegenerative diseases. Our current pipeline of gene therapy candidates targets GM1 gangliosidosis, GM2 gangliosidosis (including Tay-Sachs disease and Sandhoff disease), and Parkinsons disease. Axovant is focused on accelerating product candidates into and through clinical trials with a team of experts in gene therapy development and through external partnerships with leading gene therapy organizations. For more information, visit http://www.axovant.com.

About Invitae

Invitae Corporation (NVTA) is a leading medical genetics company, whose mission is to bring comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Invitae's goal is to aggregate the world's genetic tests into a single service with higher quality, faster turnaround time, and lower prices. For more information, visit the company's website atinvitae.com.

Forward-Looking Statements

This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as "may," "might," "will," "would," "should," "expect," "believe," "estimate," and other similar expressions are intended to identify forward-looking statements. For example, all statements Axovant makes regarding costs associated with its operating activities are forward-looking. All forward-looking statements are based on estimates and assumptions by Axovants management that, although Axovant believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Axovant expected. Such risks and uncertainties include, among others, the initiation and conduct of preclinical studies and clinical trials; the availability of data from clinical trials; the expectations for regulatory submissions and approvals; the continued development of its gene therapy product candidates and platforms; Axovants scientific approach and general development progress; and the availability or commercial potential of Axovants product candidates. These statements are also subject to a number of material risks and uncertainties that are described in Axovants most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on February 10, 2020, as updated by its subsequent filings with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was made. Axovant undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

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Parag MeswaniAxovant Gene Therapies(212) 547-2523investors@axovant.commedia@axovant.com

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‘Smart toilet’ recognizes users and checks for signs of disease – Medical News Today

April 16th, 2020 1:42 pm

A team at Stanford Medicine has developed gadgets that can be fitted in an ordinary toilet to screen urine and feces and upload the encrypted health data. The technology may be particularly useful for monitoring individuals at high risk of developing particular illnesses.

Many people will be uncomfortable with the idea of cameras and sensors in their toilet. It may seem like an unthinkable intrusion into what is perhaps the most private of all activities.

But a team of developers at Stanford Medicine in Stanford, CA, believe the clinical benefits of their smart toilet could be far-reaching.

They are also confident that their toilet can safeguard the privacy of users.

Technologies that continually monitor a persons health play a growing role in healthcare.

Existing devices include smartwatches for collecting data, such as heart rate, and wearable blood pressure monitors. A skin patch is in development that tracks movement, heart rate, and breathing.

The thing about a smart toilet, though, is that unlike wearables, you cant take it off, says Prof. Sanjiv Gambhir, chair of radiology at Stanford Medicine. Everyone uses the bathroom theres really no avoiding it and that enhances its value as a disease-detecting device.

Prof. Gambhir believes the smart toilet may be particularly useful for monitoring people at high risk of conditions, such as prostate cancer, irritable bowel syndrome (IBS), and kidney failure, due to their genetic predispositions, for example.

His team developed a suite of gadgets that a person can fit in the bowl of an ordinary toilet. Its sort of like buying a bidet add-on that can be mounted right into your existing toilet, he says. And like a bidet, it has little extensions that carry out different purposes.

In a pilot study, 21 volunteers tested the device over several months.

The smart toilet is the perfect way to harness a source of data thats typically ignored and the user doesnt have to do anything differently.

Prof. Sanjiv Gambhir

A motion sensor activates the smart toilet to start capturing video data, which are then digitally analyzed.

One of the smart toilets algorithms can detect abnormal urine flow rate, stream time, and volume, which could be useful for flagging prostate problems in men, for example.

Another gauges the consistency of fecal matter from the images and classifies it according to the Bristol stool chart. This is a standardized system used by clinicians worldwide to diagnose problems such as constipation, gut inflammation, and a lack of dietary fiber.

The smart toilets software can also identify color changes in urine using urinalysis strips (dipstick tests). It can detect 10 different markers, including the number of white blood cells and the levels of specific proteins in the urine. These biomarkers can provide early warnings of diseases, such as kidney infections and bladder cancer.

According to an article describing the technology in Nature Biomedical Engineering, the toilets abilities are comparable to the performance of trained medical personnel.

Encrypted data from the toilet upload to a secure cloud server. In the future, this information could integrate with a healthcare providers record-keeping system for easy access by the individuals doctor.

The Stanford team envisages an app sending a text alert to the healthcare team if the device detects an urgent issue, such as blood in someones urine.

Identifying who is using the toilet will be critical in a household of several people.

The whole point is to provide precise, individualized health feedback, so we needed to make sure the toilet could discern between users, Prof. Gambhir said. To do so, we made a flush lever that reads fingerprints.

However, in case someone uses the toilet and another flushes it, or if the toilet has an auto-flush system, a camera captures what the article calls the distinctive features of their anoderm [skin tissue lining of the anus].

We know it seems weird, but as it turns out, your anal print is unique, says Prof. Gambhir.

The recognition system is fully automatic, which means that no human will see the scans.

Despite the teams best efforts to ensure user privacy and data confidentiality, the smart toilet may prove a hard sell.

A survey conducted by the researchers of 300 prospective users revealed that only 15% described themselves as very comfortable with the concept.

The researchers plans include recruiting more volunteers to test the toilet and individualizing the available tests. A patient with diabetes might want glucose levels in their urine checked, for example.

In addition to urine tests, the team would also like to build into their toilet the ability to carry out molecular analysis of stool samples.

Thats a bit trickier, but were working toward it, says Prof. Gambhir.

If successful, one advantage for the squeamish will be that they no longer have to collect their own stool samples and take them to a clinic for testing.

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Here’s What We Know about the Most Touted Drugs Tested for COVID-19 – Scientific American

April 16th, 2020 1:42 pm

As the COVID-19 pandemic continues to claim lives around the world, there are no specific treatments for the disease beyond supportive care. Several drugs already prescribed for other illnesses have shown promise against the novel coronavirus in preclinical studies. And they are now being tested in clinical trials or given to patients on a compassionate-use basis. But experts warn that these medications have yet to prove effective in treating COVID-19 patients.

As of this writing, the virus has infected more than two million people worldwide and caused more than 130,000 deaths. A vaccine and new treatments could take years to fully develop, but the World Health Organization recently launched a large international trial called Solidarity to test four existing therapies. They are the closely related malaria drugs chloroquine and hydroxychloroquine; the antiviral medication remdesivir (originally developed to treat Ebola); the antiviral combination of lopinavir and ritonavir (used for HIV); and those two HIV drugs plus the anti-inflammatory small protein interferon beta. A number of separate clinical trials of these medications and others are underway in several countries, including the U.S.

The U.S. Food and Drug Administration has approved remdesivir for treating COVID-19 patients under the compassionate-use protocol (a designation that gives patients with life-threatening illnesses access to an experimental drug). And the agency has granted an emergency use authorizationwhich allows for otherwise unapproved drugs or uses during an emergencyfor chloroquine and hydroxychloroquine.

None of these therapies are proven, says Stanley Perlman, a professor of microbiology and immunology at the University of Iowa. Only the results of randomized clinical trials can show whether they work, he adds.

Here is what scientists know so far about some of the most prominent drugs currently being tested as treatments for the potentially deadly infection.

President Donald Trump has repeatedly touted the malaria drugs chloroquine and hydroxychloroquine as a treatment for COVID-19despite a lack of clinical evidence that they work for the disease. The presidents comments set off a scramble among doctors and patients to obtain the drugswhich are frequently used to treat autoimmune diseases such as rheumatoid arthritis and lupusand there is now a shortage of them in the U.S. Also, these substances can be dangerous in healthy people: a man in Arizona died after ingesting a fish-tank cleaner containing a type of chloroquine that is not approved for human use. On March 28 the FDA issued an emergency authorization for administering chloroquine or hydroxychloroquine to COVID-19 patientsbut many experts say the widespread usage of these drugs is premature.

The clinical support is very, very minimal, says Maryam Keshtkar-Jahromi, an assistant professor of medicine at the Johns Hopkins University School of Medicine, who co-authored an article in the American Journal of Tropical Medicine and Hygiene calling for more randomized controlled trials of chloroquine and hydroxychloroquine. The drugs do not show strong evidence at this point, she adds.

A few preclinical studies have suggested these compounds could be effective at blocking infection with the novel coronavirus (officially called SARS-CoV-2), but there has been very little good evidence from clinical trials in patients with the illness it causes, COVID-19. A controversial small, nonrandomized trial of hydroxychloroquine combined with the antibiotic azithromycin in France suggested that COVID-19 patients given the treatment had less virus, compared with those who refused the drugs or those at another hospital who did not receive them. But experts have questioned the studys validity, and the society that publishes the journal in which it appeared has issued a statement of concern about the results, according to Retraction Watch. (Scientific American reached out to the papers authors for comment but did not hear back from them.) A preprint study in China also claimed to show that hydroxychloroquine benefitted COVID-19 patients, but it had significant methodology problems, Keshtkar-Jahromi says. The issues included confounding variables, such as the fact that all of the subjects received other antiviral and antibacterial treatments.

Some scientists say the preclinical evidence is strong enough to support chloroquines use, however. We know how it acts at the cellular level against the virus. We have preclinical proof, says Andrea Cortegiani, an intensivist and researcher in the departments of anesthesia and intensive care and of surgical, oncological and oral sciencesat the University of Palermo in Italy. Second, its a cheap drug, available all over world, adds Cortegiani, who is also a clinician at University Hospital Paolo Giaccone in Italy.

Chloroquine and hydroxychloroquine have been hypothesized to work against COVID-19 by changing the pH required for SARS-CoV-2 to replicate. Given their use in autoimmune disorders, these medications could also play a role in dampening the immune response to the viruswhich can be deadly in some patients.

But these drugs cardiac toxicity is a concern, Keshtkar-Jahromi says. There have been some reports of myocarditis, or inflamed heart tissue, in people with COVID-19 who have not taken chloroquine or hydroxychloroquine. If patients receiving one of these medications die of heart complicationsand are not in a clinical trialdoctors cannot know if the drug contributed to higher chance of death.*

A drug that modulates the immune response could also make someone more vulnerable to other viral or bacterial infections. Its a double-edged sword, says Sina Bavari, chief science officer and founder of Edge BioInnovation Consulting in Frederick, Md., who co-authored Keshtkar-Jahromis article in the American Journal of Tropical Medicine. Giving a drug to suppress the immune system has to be done with extreme care.

We are not saying, Dont [prescribe chloroquine], Bavari says. We are saying, More data is needed to better understand how the drug worksif it works.

This experimental antiviral drug was developed to treat Ebola, and it has been shown to be safe for use in humans. It is a broad-spectrum antiviral that blocks replication in several other coronaviruses, according to studies in mice and in cells grown in a lab. In addition to the WHO investigation, at least two trials in China and one in the U.S. are currently evaluating remdesivir in COVID-19 patients. Results for the Chinese trials are expected later this month.

As of this moment, we dont have data for remdesivir in human COVID-19 disease, says Barry Zingman, a professor of medicine at Albert Einstein College of Medicine and clinical director of infectious diseases at Montefiore Health Systems Moses Campus. The two related institutions, both located in New York City, recently joined a nationwide clinical trial of the drug. Our patients are randomized, so we dont know whos getting the drug or a placebo. [But] we have seen some patients do remarkably well, Zingman says. Trial results are on track for publication sometime in the next six to eight weeks, he adds.

As Scientific American reported previously, remdesivir works by inhibiting an enzyme called an RNA-dependent RNA polymerase, which many RNA virusesincluding SARS-CoV-2use to replicate their genetic material. Timothy Sheahan of the University of North Carolina at Chapel Hill and his colleagues have shown the drug is effective against the coronaviruses that cause severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), respectively, as well as some of the viruses behind the common cold. The team is currently in the process of testing the drugs efficacy against SARS-CoV-2. A recent study of compassionate use of remdesivir in 53 severe COVID-19 patients found that 63 percent of those taking the drug improved, but it was not a randomized controlled trial.

Remdesivir has some chance, Perlman says. If we can give [the drug] early in the disease course, it could work. To know for sure, scientists must await the results of the ongoing clinical trials.

One limitation with remdesivir is that it must be given intravenously, so patients can only get it in a hospital. Sheahan and his colleagues at Emory University have recently developed a related drug called EIDD-2801, which can be taken in pill form. Like remdesivir, the medication works as a nucleoside analogue, interfering with viral replication. It was effective at preventing SARS-Cov-2-infected lung cells from replicating in a lab dish and related viruses from doing so in mice.

The HIV drugs ritonavir and lopinavir (sold as a combination therapy by AbbVie under the brand name Kaletra) have been tested against COVID-19 in a few clinical trials. The initial data have not shown them to be effective, however. A study in the New England Journal of Medicine found they conferred no benefit beyond standard care.

The drug combination is what is known as a protease inhibitor, and it works by blocking an enzyme involved in viral replication. But its action is specific to HIV and so is unlikely to work for SARS-CoV-2, Perlman says. If you have the key to a car, and you try to put it in your car, the odds of it working are one in a million, he says. Kaletra [targets] a completely different lock than the one for COVID-19.

Nevertheless, the WHO trial includes a group of COVID-19 patients who will receive these drugs on their ownand another group that will receive them in combination with interferon beta, a small cell-signaling molecule used to treat multiple sclerosis. The molecule is a massive orchestrator of immune response, Perlman notes, so it must be used carefully. In mouse studies of the SARS and MERS coronaviruses, it halted the infections when administered early. When it was given later, he says, the mice died. Using a drug that activates the immune system could be helpful in the beginning of an infection, but giving it too late could be deadly.

Researchers are also considering a number of other therapies that tamp down the rampant immune response seen in severe COVID-19 cases. Such a flood of immune cells in the lungsknown as a cytokine stormcan lead to death. Many of the sickest patients have elevated levels of an inflammatory protein called interleukin-6 (IL-6). Research in China has suggested that Actemra (tocilizumab), an IL-6-blocking antibody drug made by Roche, shows promise against COVID-19. And Chinese authorities have recommended the drug in their treatment guidelines. Roche has since initiated a phase III randomized controlled clinical trial for the medication. In the U.S., Michelle Gongchief of the division of critical care at Montefiore and Albert Einstein and director of critical care research at Montefioreand her colleagues are among dozens of groups conducting a double-blind, placebo-controlled clinical trial of a related drug called sarilumab, which is already approved for treating rheumatoid arthritis. Sarilumab will only be given to the sickest individuals: to be part of the trial, patients must be hospitalized with COVID-19 and in severe or critical condition.

Another treatment approach involves injecting COVID-19 patients with blood plasma from people who have recovered from the illness. The FDA recently issued guidance on the investigational use of such convalescent plasma, which contains antibodies to the coronavirus, and clinical trials are underway.

Blood from disease survivors has been used as a treatment throughout historyfrom polio-infected horses in the 1930s to former Ebola patients in 2014. There is a long-lasting rationale for the use of convalescent plasma against any infectious disease, Cortegiani says. One problem, however, is that scientists do not know whether people develop strong immunity against SARS-CoV-2. And it is not easy to collect plasma containing enough antibodies, he adds. Another issue is the shortage of eligible donors. Some companies are looking into ways to produce these antibodies artificially. In the meantime, a number of hospitals are searching for volunteers to donate plasma.

None of the therapies described above have yet been proved to treat COVID-19. But some answers can be expected in the next few weeks and months as the results of clinical trials emerge. Until then, Cortegiani says, we cannot say, This drug is more promising than the other one. We can only say, There is a rationale for it.

Read more about the coronavirus outbreakhere.

*Editors Note (4/16/20): This paragraph was edited after posting to correct Maryam Keshtkar-Jahromis comments about her concerns with chloroquine and hydroxychloroquine.

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Looking to the Future of Cell and Gene Therapies – Technology Networks

April 16th, 2020 1:42 pm

At the front lineof advances in personalized medicine are cell and gene therapies. These are two overlapping fields of medical research whereby the overall aim is to treat the underlying causes of both genetic and acquired diseases.

Is the promise of personalized medicine on the edge of being delivered? Decades of research and advances in genomics, cell biology, cancer and analytical technologies have permitted exciting progress in the cell and gene therapy space recently. Technology Networks recently spoke with three of the leaders in this space, Allogene Therapeutics, bluebird bioInc. andMogrify to gain their insights on the next developments in cell and gene therapy.

Joe Foster, COO, Mogrify.

"We are on the cusp of new breakthroughs in this field and that evolution of engineered cell therapy has the potential to expand beyond cancer. Engineering, synthetic biology and gene editing has opened the door beyond allogeneic cell therapy. There is a bright future with transformative technologies that may hold the key to addressing solid tumors."

David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder, Allogene Therapeutics.

"Although gene therapies are still a nascent technology, they present a new paradigm for healthcare, offering a one-time treatment that can address the underlying genetic cause of certain severe genetic diseases and cancer. We anticipate that the three techniques being studied for gene therapy gene editing, gene addition and gene-based immunotherapy will become more distinct and that the entire treatment journey will become more efficient."

Martin Butzal, Head of Medical Europe, bluebird bio.

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Where Did This Coronavirus Originate? Virus Hunters Find Genetic Clues In Bats – NPR

April 16th, 2020 1:42 pm

Cave nectar bat (Eonycteris spelaea) from Singapore. Justin Ng/Linfa Wang hide caption

Cave nectar bat (Eonycteris spelaea) from Singapore.

Updated at 11 a.m. ET

Dr. Linfa Wang, a virologist at the Duke-National University of Singapore, has been working around the clock to help Singapore fight this coronavirus. He hasn't hugged his daughter in over two months.

"We're in a war zone right now. Everything comes to me very fast," Wang said in an interview with NPR's Short Wave podcast. He's given over 100 interviews since January, when international reports first surfaced of a new coronavirus.

Since then, scientists have learned a great deal about the coronavirus, now called SARS-CoV-2. And one of the mysteries they're still trying to untangle is where the virus came from in the first place. Scientific evidence overwhelmingly points to wildlife, and to bats as the most likely origin.

Wang is an expert in emerging zoonotic diseases, or diseases hosted in animals that spread to humans. The CDC estimates that six out of ten infectious diseases in people come from animals. Among them are Lyme disease, Rabies, West Nile, and diseases caused by coronaviruses, including this coronavirus and the SARS virus.

The 2003 outbreak of SARS was eventually traced to horseshoe bats in a cave in the Yunnan province of China, confirmed by a 2017 paper published in the journal Nature. It was a detective hunt that took over a decade, sampling the feces, urine, or blood of thousands of horseshoe bats across the country and seeing if those samples are a genetic match to the virus.

The work of virus hunting of tracking an outbreak to its origin point can take years. Wang stresses that pinpointing the true origin of this coronavirus will take time as well. "Of course, the technology and everything is much more advanced 17 years later [since the 2003 SARS outbreak]. But, for us to try to solve everything in two to three months is just not feasible."

'This is a product of nature'

In early January 2020, Chinese scientists sequenced the entire genome for SARS-CoV-2 and published it online. Researchers at the Wuhan Institute of Virology in China compared its genome to a library of known viruses and found a 96% match with coronavirus samples taken from horseshoe bats from Yunnan.

"But that 4% difference is actually a pretty wide distance in evolutionary time. It could even be decades," says Dr. Robert F. Garry, professor of microbiology and immunology at Tulane University School of Medicine.

That extra 4% suggests the SARS-CoV-2 may not have evolved from bats alone, but may include viral material from another animal. In that case, the virus would have continued to evolve through natural selection in that animal. Moreover, that other animal may have acted as an "intermediate host," ultimately transmitting the virus to humans.

With this coronavirus, scientists aren't fully clear on whether an intermediate host was involved nor the chain of cross-species transmission to humans. Studies have found a genetic similarity between this coronavirus and coronaviruses found in pangolins, also called scaly anteaters, which are vulnerable to illegal wildlife trade.

Given that some China's earliest COVID-19 patients were connected to the Hunan Seafood Wholesale Market in Wuhan, it is likely the seafood market played a role in amplifying the virus. However, there is not enough evidence to prove that is where the virus transmitted from animals to humans. There is also evidence emerging that among the first 41 patients hospitalized in China, 13 had no connection to this particular marketplace. The path of the pathogen is still unknown.

As for clues the virus holds about its animal origins, Robert Garry and fellow researchers have hypothesized that SARS-CoV-2 could be a blend of viruses from bats and another animal.

"The receptor binding domain actually shares a lot of sequence similarity to a virus that's found in the pangolin" Garry said, referring to the receptor-binding mechanism that allows the virus to form a strong attachment to human cells. "So, those sequences probably did arise from a virus like the pangolin coronavirus, or maybe some other coronavirus that can circulate in pangolins or some other animals." Further genetic analysis is needed to figure this out.

In studying the genome, Garry also confirms the virus came from wildlife. "This is a product of nature. It's not a virus that has arisen in a laboratory by any scientist, purposely manipulating something that has then been released to the public," he said.

'It's A Billion Dollar Question'

So, why are bats such good hosts for viruses?

"I used to say it's a million dollar question. Now I say it's a billion dollar question," said Wang, speaking to NPR's Short Wave podcast on Tuesday.

Bats are critically important for pollinating flowers and dispersing seeds. They catch bugs, the same ones that bite us and eat some of our crops. But bats also harbor some of the toughest known zoonotic diseases.

The Rabies virus, the Marburg virus, the Hendra and Nipah viruses all find a natural reservoir in bats, meaning those viruses live in bats without harming them. The Ebola outbreak in West Africa was traced to a bat colony. The SARS virus originates in bats, along with other coronaviruses. And now, SARS-CoV-2 is linked to bats too.

Wang believes bats' high tolerance for viruses may have to do with the fact that they are the only mammal that's adapted for flight.

"During flight, their body temperature goes all the way to 42 degrees (or 108 degrees Fahrenheit). And their heartbeat goes up to 1000 beats per minute," Wang said.

Flying several hours a day, bats burn a great deal of energy. This creates toxic free radicals that damage their cells, but Wang's research has shown that bats have also evolved abilities to repair and minimize that cellular damage. Those same defensive abilities may help them not only tolerate flight, but also to fight infectious diseases in a way that human bodies cannot.

"Our hypothesis is that bats have evolved a different mechanism to get the balance right for defensive tolerance. And that favors the virus to live peacefully with bats," said Wang.

Peter Daszak, President of the U.S.-based non-profit Ecohealth Alliance, says that even if bats are the origin, they are not to blame for the pandemic.

"It's not bats. It's us. It's what we do to bats that drives this pandemic risk," Daszak said. His research demonstrates how interactions between wildlife and livestock, food and agriculture practices, as well as humans close proximity to animals in densely populated areas, create the conditions for viral outbreaks.

"One of the positive things about finding out that we're actually behind these pandemics is that it gives us the power to do something about it. We don't need to get rid of bats. We don't need to do anything with bats. We've just got to leave them alone. Let them get on, doing the good they do, flitting around at night and we will not catch their viruses," Daszak said.

Given that infectious and zoonotic diseases have been on the rise for decades, Wang is frustrated by the fact that countries around the world failed to understand the impact this novel coronavirus outbreak would have.

"I'm so angry right now. This COVID-19 outbreak, before January 20th, you could say it's China's fault. The Chinese government. But after January 20th, the rest of the world is still not taking it seriously. Our political system, our diplomatic system, our international relationship system is just not ready," Wang said.

January 20th is when Chinese health officials confirmed the new coronavirus could be transmitted between humans and the World Health Organization kicked into high gear to evaluate the global risk. There were more than 200 cases then. Now, the confirmed case count is nearing 2 million worldwide.

Email the show at shortwave@npr.org.

This episode was produced by Brit Hanson, edited by Viet Le, and fact-checked by Emily Vaughn.

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International Pompe Day highlighting those who live with rare genetic condition – KMBC Kansas City

April 16th, 2020 1:42 pm

Mary Joyce of Overland Park, Kansas, lives each day as if it is a gift because, in her mind, it absolutely is. She lives with the rare Pompe disease, a degenerative muscle disease, which took her sisters life in 2013. My sister passed away only at 53," Joyce said. "I call myself in the bonus years at age 58!April 15 is International Pompe Day. Its a day to highlight the people who live with the genetic condition and to bring attention to it. Joyce said its hard to explain what Pompe has done to her. It looks like youre healthy from the outside, but its all inside," she said. "My muscles are like rubber bands -- like noodles inside. Her sister Shirley was older than her by three years, and was diagnosed first. Joyce said, When she first started having symptoms, and falling inside her house, she would call me and me and the boys would go over and help her. Years after her symptoms started, a doctor in St. Louis diagnosed Shirley. A few years later, Shirley diagnosed her sister. She said, 'You have the waddle!' Joyce said. Shirley noticed the way Marys hips moved when she walked, and urged her to get tested.The test came back positive for Pompe. Both women qualified for a clinical trial for a medication to treat Pompe. Once the double-blind study was completed and a year had passed, the sisters were told Joyce had received the medication. Shirley had not. "I felt so bad that she did not get the drug," Joyce said. "That just broke my heart. I thought why did I get it? I didn't deserve it. She was having symptoms. I was just barely starting."When asked what she misses most about her sister, Joyce answered, Everything.Joyce is now a grandmother of two, and is watching her sisters grandchildren grow. She gets enzyme replacement therapy every-other week. And she dreams, "that no one will have to endure this. That itll be somehow wiped out -- that there will be a medicine to get those newborns right away before any damage is done to the sweet babies, and that they have a wonderful, normal life.

Mary Joyce of Overland Park, Kansas, lives each day as if it is a gift because, in her mind, it absolutely is.

She lives with the rare Pompe disease, a degenerative muscle disease, which took her sisters life in 2013.

My sister passed away only at 53," Joyce said. "I call myself in the bonus years at age 58!

April 15 is International Pompe Day. Its a day to highlight the people who live with the genetic condition and to bring attention to it.

Joyce said its hard to explain what Pompe has done to her.

It looks like youre healthy from the outside, but its all inside," she said. "My muscles are like rubber bands -- like noodles inside.

Her sister Shirley was older than her by three years, and was diagnosed first.

Joyce said, When she first started having symptoms, and falling inside her house, she would call me and me and the boys would go over and help her.

Years after her symptoms started, a doctor in St. Louis diagnosed Shirley. A few years later, Shirley diagnosed her sister.

She said, 'You have the waddle!' Joyce said.

Shirley noticed the way Marys hips moved when she walked, and urged her to get tested.

The test came back positive for Pompe.

Both women qualified for a clinical trial for a medication to treat Pompe. Once the double-blind study was completed and a year had passed, the sisters were told Joyce had received the medication. Shirley had not.

"I felt so bad that she did not get the drug," Joyce said. "That just broke my heart. I thought why did I get it? I didn't deserve it. She was having symptoms. I was just barely starting."

When asked what she misses most about her sister, Joyce answered, Everything.

Joyce is now a grandmother of two, and is watching her sisters grandchildren grow.

She gets enzyme replacement therapy every-other week. And she dreams, "that no one will have to endure this. That itll be somehow wiped out -- that there will be a medicine to get those newborns right away before any damage is done to the sweet babies, and that they have a wonderful, normal life.

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When Damaged, the Adult Brain Repairs Itself by Going Back to the Beginning – UC San Diego Health

April 16th, 2020 1:42 pm

When adult brain cells are injured, they revert to an embryonic state, according to new findings published in the April 15, 2020 issue of Nature by researchers at University of California San Diego School of Medicine, with colleagues elsewhere. The scientists report that in their newly adopted immature state, the cells become capable of re-growing new connections that, under the right conditions, can help to restore lost function.

Repairing damage to the brain and spinal cord may be medical sciences most daunting challenge. Until relatively recently, it seemed an impossible task. The new study lays out a transcriptional roadmap of regeneration in the adult brain.

A cross-section of a rat brain depicts cells (in blue) expressing normal levels of the Huntingtin gene while cells (in red) have had the gene knocked out. The latter cells, without the Huntingtin gene, displayed less regeneration.

Using the incredible tools of modern neuroscience, molecular genetics, virology and computational power, we were able for the first time to identify how the entire set of genes in an adult brain cell resets itself in order to regenerate. This gives us fundamental insight into how, at a transcriptional level, regeneration happens, said senior author Mark Tuszynski, MD, PhD, professor of neuroscience and director of the Translational Neuroscience Institute at UC San Diego School of Medicine.

Using a mouse model, Tuszynski and colleagues discovered that after injury, mature neurons in adult brains revert back to an embryonic state. Who would have thought, said Tuszynski. Only 20 years ago, we were thinking of the adult brain as static, terminally differentiated, fully established and immutable.

But work by Fred Rusty Gage, PhD, president and a professor at the Salk Institute for Biological Studies and an adjunct professor at UC San Diego, and others found that new brain cells are continually produced in the hippocampus and subventricular zone, replenishing these brain regions throughout life.

Our work further radicalizes this concept, Tuszynski said. The brains ability to repair or replace itself is not limited to just two areas. Instead, when an adult brain cell of the cortex is injured, it reverts (at a transcriptional level) to an embryonic cortical neuron. And in this reverted, far less mature state, it can now regrow axons if it is provided an environment to grow into. In my view, this is the most notable feature of the study and is downright shocking.

To provide an encouraging environment for regrowth, Tuszynski and colleagues investigated how damaged neurons respond after a spinal cord injury. In recent years, researchers have significantly advanced the possibility of using grafted neural stem cells to spur spinal cord injury repairs and restore lost function, essentially by inducing neurons to extend axons through and across an injury site, reconnecting severed nerves.

Last year, for example, a multi-disciplinary team led by Kobi Koffler, PhD, assistant professor of neuroscience, Tuszynski, and Shaochen Chen, PhD, professor of nanoengineering and a faculty member in the Institute of Engineering in Medicine at UC San Diego, described using 3D printed implants to promote nerve cell growth in spinal cord injuries in rats, restoring connections and lost functions.

The latest study produced a second surprise: In promoting neuronal growth and repair, one of the essential genetic pathways involves the gene Huntingtin (HTT), which, when mutated, causes Huntingtons disease, a devastating disorder characterized by the progressive breakdown of nerve cells in the brain.

Tuszynskis team found that the regenerative transcriptome the collection of messenger RNA molecules used by corticospinal neurons is sustained by the HTT gene. In mice genetically engineered to lack the HTT gene, spinal cord injuries showed significantly less neuronal sprouting and regeneration.

While a lot of work has been done on trying to understand why Huntingtin mutations cause disease, far less is understood about the normal role of Huntingtin, Tuszynski said. Our work shows that Huntingtin is essential for promoting repair of brain neurons. Thus, mutations in this gene would be predicted to result in a loss of the adult neuron to repair itself. This, in turn, might result in the slow neuronal degeneration that results in Huntingtons disease.

Co-authors include: Gunnar Poplawski, Erna Van Nierkerk, Neil Mehta, Philip Canete, Richard Lie, Jessica Meves and Binhai Zheng, all at UC San Diego; Riki Kawaguchi and Giovanni Coppola, UCLA; Paul Lu, UC San Diego and Veterans Administration Medical Center, San Diego; and Ioannis Dragatsis, University of Tennesee.

Funding for this research came, in part, from the Dr. Miriam and Sheldon G. Adelson Medical Research Foundation, the Veterans Administration (Gordon Mansfield Consortium for Spinal Cord Regeneration), the National Institutes of Health (NS09881, EB014986), the Gerbic Family Foundation and the NINDS Informatics Center for Neurogenetics and Neurogenomics (NS062691).

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When Damaged, the Adult Brain Repairs Itself by Going Back to the Beginning - UC San Diego Health

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