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The iMUSE yoghurt & lemon flavoured drink contains lactococcus lactis strain plasma which the firm claims to have immune functionality to fight infectious disease in the country.

The drink contains 100 billion lactococcus lactis plasma, which is a lactic acid bacteria and an ingredient used exclusively by the Kirin Group.

According to Interfood Shareholding Company (Kirin Holdings subsidiary), general manager of marketing, Takeshi Fukushima: The Health and well-being trend is emerging in Vietnam. More people are taking up supplements.

The firm said while Vietnamese were highly health-conscious and spending more money on nutritional healthcare products, it said the spread of infectious diseases like dengue fever and hepatitis in the country was becoming a problem.

Hence, the yoghurt & lemon flavoured drink could propose new health value of drinking soft drinks to manage ones health in an effort to help the country solve the social problem, Kirin said.

Fukushima said the drink was able to enhance the anti-viral immune system and maintain overall health.

Its other benefits include reducing the risks of cold and flu symptoms, enhance health of skin from the inside, and reduce symptoms of fatigue in physical activity.

The Kirin Group is currently conducting research especially in the area of infectious diseases, to help those vulnerable, and contribute to achieving the United Nations Sustainable Development Goals (SDGs).

Fukushima told NutraIngredients-Asia, the first month of sales in Vietnam achieved 250% versus target.

It retails for 13,000VND (US$0.50) per 280ml at supermarkets, convenience stores, school cafeterias, and school stores in Vietnam.

Kirin Group had only promoted the iMUSE brand containing lactococcus lactis strain plasma mainly in Japan.

The drink is the first product sold overseas under the iMUSE brand.

This move is part of Kirins business strategy to expand the iMUSE brand in South East Asia.

Vietnam was selected for its population of 94 million, and 7.1% annual real-term growth in gross domestic product (GDP).

Original post:
Kirin's functional food brand expands to Vietnam with immunity-boosting probiotic drink - BeverageDaily.com

In a new study, scientists observed several simultaneous reactions in mice given a common chemotherapy drug: Their gut bacteria and tissue changed, their blood and brains showed signs of inflammation, and their behaviors suggested they were fatigued and cognitively impaired.

The research is the first to show these combined events in the context of chemotherapy, and opens the door to the possibility that regulating gut bacteria could not only calm chemo side effects like nausea and diarrhea, but also potentially lessen the memory and concentration problems many cancer survivors report.

More research is needed to further understand how the chemo-modified gut influences the brain in a way that can have an impact on behavior. The same lab at The Ohio State University is continuing mouse studies to test the relationship and running a parallel clinical trial in breast cancer patients.

This is the first time anyone has even looked to see if theres a link between the gut symptoms and the brain symptoms associated with chemotherapy, said lead author Leah Pyter, assistant professor ofpsychiatry and behavioral healthand an investigator in theInstitute for Behavioral Medicine Researchat Ohio State. There have been studies in humans that indicate that chemo alters microbes in the gut, and our study in mice had similar results.

We were able to see that there are brain changes at the same time as the gut changes. We also looked at inflammation, and yes, there are all these changes happening at the same time. So there are correlations, and now were looking into causality.

The study is published today (Nov. 11) in the journal Scientific Reports.

For this study, female mice received six injections of the chemotherapy drug paclitaxel and a control group of mice received placebo injections. Compared to the controls, the treated mice lost weight and showed signs of fatigue, and their performance on tests suggested they had memory loss.

The treated animals guts, blood and brains were also affected in ways not seen in the control mice. The mix of bacteria in the gut microbiome changed, and the tissue lining the colon became abnormally extended. Specific proteins were present in circulating blood and the brain along with activated immune cells in the brain all indicating the immune system was busy producing a total-body inflammatory response.

The sequence of events suggested all these physiological changes were related: The gut was showing signs of permeability, meaning bits of bacteria could slip out of tight junctions in the intestine, an event that triggers an immune system attack. When the brain detects through the blood and neural signals that the bodys immune system is activated, the brain responds in kind with its own inflammation. And brain inflammation is the culprit behind the mental fog symptoms known as chemo brain.

Pyters team tested all the data for associations and found the strongest correlations between changes in the gut microbes and in the colon lining and the activation of immune cells called microglia in the brain.

Every time chemo reduced bacteria in the gut, that reduction was correlated with these cells in the brain, said Pyter, also a member of theCancer Control Research Program at Ohio States Comprehensive Cancer Center.

This suggests chemotherapy is affecting the microbes in the gut and affecting the lining of the gut, and both of those changes cause inflammation in the periphery, which creates signals that promote inflammation in the brain, she said. Thats how we get the brain involvement through the immune system. And inflammation in the brain leads to sickness behaviors like fatigue and weight loss, as well as cognitive impairment.

Confirmation of these connections could lead to interventions for cancer patients either dietary strategies such as probiotics or prebiotics or possibly fecal transplantation to promote bacteria and conditions in the gut that protect the brain from inflammation, which should reduce chemo brain symptoms.

This is just the first step of trying to broach the concept to see if these harsh gut effects of chemo have anything to do with chemo brain. It looks like it has potential, Pyter said.

This work was supported by The Ohio State University Wexner Medical Center and grants from the National Institutes of Health.

Kelley Jordan and Browning Haynes of Ohio State and Brett Loman and Michael Bailey of Nationwide Childrens Hospital were study co-authors.

Read more here:
The gut may be the ticket to reducing chemo's side effects - The Ohio State University News

SAN DIEGO and PENNINGTON, N.J., Nov. 12, 2019 /PRNewswire/ --OncoSec Medical Incorporated ("OncoSec") (Nasdaq:ONCS), a company developing late-stage intratumoral cancer immunotherapies, today announced outcomes from a safety and biomarker analysis on its lead product candidate, TAVO, at theSociety for Immunotherapy of Cancer(SITC) 34th Annual Meeting. Outcomes demonstrated treatment-related changes in key immune biomarkers coinciding with clinical outcomes across both KEYNOTE-695 and KEYNOTE-890 trials of TAVO in combination with KEYTRUDA (pembrolizumab).

In the poster, which was presented on November 9, 2019, investigators noted that following TAVO administration, increased tumor infiltrating CD8+ T-cells were consistent with tumor shrinkage in anti-PD-1 antibody refractory melanoma and chemotherapy refractory metastatic triple negative breast cancer (mTNBC). The interim analysis also highlighted the systemic immune effects of TAVO, including increases in the frequencies of circulating memory T cells and reduced frequencies of circulating immuno-suppressive PMN-MDSC cells in predominately responding patients across both indications. Additionally, a broad safety analysis of over 200 patients treated with TAVO in multiple cancer indications across several clinical trials including TAVO as a monotherapy as well as in combination with KEYTRUDA was reported. There were no Grade 4 or 5 treatment-related adverse events reported and only 7.9% of patients experienced Grade 3 treatment-related adverse events across all TAVO studies, underscoring a predictable and consistently well-tolerated safety profile.

OncoSec is currently evaluating TAVO in combination with KEYTRUDA in a pivotal trial for Stage III/VI anti-PD1 checkpoint resistant metastatic melanoma and a phase 2 trial for late stage chemo-refractory metastatic TNBC, both KEYNOTE-designated studies. The immune data presented at SITC represented those patients for whom pre- and post-treatment blood and tumor samples were obtained in these ongoing KEYNOTE studies.

"The data presented at SITC were consistent with earlier published data showing that the well-established indicators of immune response are present in the blood and tumor tissue post-treatment and that the presence of these immune signatures continues to be associated with clinical response," said Daniel J. O'Connor, CEO of OncoSec. "Further, with more than 200 TAVO-treated patients, we clearly see that these powerful clinical responses are delivered with an excellent safety profile as both a monotherapy and importantly, in combination with anti-PD-1 therapy."

About OncoSec Medical IncorporatedOncoSec is a clinical-stage biotechnology company focused on developing cytokine-based intratumoral immunotherapies to stimulate the body's immune system to target and attack cancer. OncoSec has built a deep and diverse clinical pipeline utilizing its primary technology, TAVO(tavokinogene telseplasmid) as a potential treatment for multiple cancer indications either as a monotherapy or in combination with leading checkpoint inhibitors; with the latter potentially enabling OncoSec to address a great unmet medical need in oncology: anti-PD-1 non- responders. In addition to TAVO, OncoSec is identifying and developing new DNA-encoded therapeutic candidates and tumor indications for use with its new Visceral Lesion Applicator (VLA), to target deep visceral lesions, such as liver, lung or pancreatic lesions. For more information, please visitwww.oncosec.com.

TAVOis a registered trademark of OncoSec Medical Incorporated.

KEYTRUDAis a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Forward Looking StatementsSome of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The factors that could cause our actual results to differ materially include: the status, progress and results of our clinical programs; our ability to obtain regulatory approvals for, and the level of market opportunity for our product candidates; our business plans, strategies and objectives, including plans to pursue collaboration, licensing or other similar arrangements or transactions; expectations regarding our liquidity and performance, including expense levels, sources of capital and ability to maintain operations as a going concern; the competitive landscape of our industry; and general market, economic and political conditions; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not intend to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

Company Contact:Gem HopkinsHead of Corporate Communications858-210-7334ghopkins@Oncosec.com

View original content to download multimedia:http://www.prnewswire.com/news-releases/oncosec-presents-immunological-data-associated-with-positive-tumor-response-from-tavo-keynote-studies-evaluating-patients-with-advanced-solid-tumors-at-the-society-for-immunotherapy-of-cancer-sitc-34th-annual-meeting-300956116.html

SOURCE OncoSec Medical Incorporated

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OncoSec Presents Immunological Data Associated with Positive Tumor Response from TAVO(TM) KEYNOTE Studies Evaluating Patients with Advanced Solid...

A nurse prepares a vaccine against Ebola in Goma on August 7, 2019. (Photo by AUGUSTIN WAMENYA/AFP ... [+] via Getty Images)

Its official. We now have a real Ebola vaccine. Not a kind-of-almost-sort-of-there vaccine. Not an experimental-use vaccine. Not a vaccine just for macaques. No, this is a vaccine that the European Commission has just approved for use in humans, the first of its kind.

According to todays announcement, the European Commission has granted Merck Sharp and Dohme B.V. marketing authorization in Europe for their Ebola vaccine, named Ervebo. The approval came not too long after the European Medicines Agency (EMA) had recommended approval in mid-October.

This is big. Actually, its big times big plus big. Having a vaccine to protect against the Ebola virus is a game changer. The Ebola virus, in technical terms, really sucks. It is a nasty virus that can cause a severe and deadly hemorrhagic fever. Fever means fever as in body temperature rising. And hemorrhagic means bleeding as in blood leaking out of blood vessels inside your body, in your skin, and potentially in your eyes, nose, ears, mouth, and rectum.

05 September 2019, Congo, Goma: Signposts on the premises of the UN peace mission "Monusco" point ... [+] out symptoms, danger of infection and course of disease of Ebola. (Photo by Kay Nietfeld/picture alliance via Getty Images)

How can the virus wreak such havoc? The virus is a sneaker sucker. It first targets cells that serve as your immune systems first line of defense. This is a bit like the Oceans 11 crew taking out the surveillance system first when trying to rob Terry Benedicts casino. As a result, your immune system cannot even recognize that something is amiss. Eventually, macrophages, which are your bodys cookie monster-like protectors, gobble up the viruses. This then triggers your macrophages to do the wrong thing. Your macrophages release proteins that initiate a cascade of events that cause the formation of small blood clots, inflammation, and leaks in your blood vessels throughout your body. This leads to the unhappy combination of you losing blood and blood flow to your organs being blocked, which starves your organs of oxygen. This process is what ends up killing up to 90% of those infected by the virus, according to the World Health Organization (WHO) Africa Region Office.

If this sounds horrible, it is. Ebola infections can be costly too. As our PHICOR teams study published in the Journal of Pathogens and Global Health showed, the cost of each case can range from several hundred dollars (if you fully recover) to close to $20K if you dont survive.

Here is the Ebola virus under a microscope. (Photo: Getty Images)

Thats why you never want to get infected by the Ebola virus. You can catch the virus from contacting the body fluids of an infected person, fruit bat, or non-human primate such as an ape or monkey. As the Centers for Disease Control and Prevention (CDC) explains, until now, the only thing that you could do to prevent an Ebola infection was to avoid the virus. That may be relatively easy in the U.S. where the Ebola virus so far has been exceedingly rare. However, that aint so easy in the middle of an outbreak such as the one that rocked West Africa from 2014 to 2016.

The Ebola vaccine works by exposing you to a form of the virus that cant cause an infection. This then prompts your immune system to in effect say, hmm, what is this? Oh, this doesnt look good. We should get prepared for when this virus returns. Think of Terry Benedict being shown the Oceans 11 crew and their plans before they even attempt the heist and how that would help the casino shore up defenses.

Health officials have been using the vaccine on an experimental basis to try to control Ebola outbreaks that have been going on in the Democratic Republic of the Congo (DRC). As described in this PBS Newshour segment, the war-torn DRC hasnt been the easiest place to test the vaccine:

Nevertheless, researchers managed to test the efficacy of the vaccine in the country. As the WHO reported in April, this vaccine had an estimated protective efficacy of 97.5% in field studies there. That would mean if a hundred people vaccinated were exposed to the virus, less than three would end up getting infected. Thats a remarkably high efficacy. After all, nothing in life is 100%. However, keep in mind that the efficacy of a vaccine also depends on how many people around you are vaccinated as weve seen with the measles vaccine as I have explained for Forbes previously.

Ebola and the Ebola vaccine didnt always get the attention that its getting today. In fact, as chronicled in the scientific journal CMAJ, the history of the Ebola vaccine reads sort of like an ugly duckling, Shes All That movie story line. It wasnt until the year 2001 that the Public Health Agency of Canadas National Microbiology Laboratory began in earnest attempts to develop an Ebola vaccine. Back then Ebola researchers struggled to secure funding because Ebola wasnt exactly a household name and working on the virus wasnt considered cool or sexy by the public and thus policy makers.

Despite these hurdles, the researchers at the Canadian laboratory persisted and by 2005 managed to develop a vaccine had perfect efficacy in protecting macaques, based on a study published in Nature Medicine. This was good news, for macaques. While these results were promising, much more work was necessary to proving that a vaccine could work in humans and be appropriately safe. Although the Canadian government had patented the vaccine, at the time, the future of the vaccine remained uncertain. It wasnt as if pharmaceutical companies were lining up to further develop the vaccine.

Everything changed in 2014 when the West Africa Ebola outbreak made international news. Suddenly, people in other continents began wondering and worrying about this deadly disease that could cause bleeding eyeballs. There were concerns about Ebola spreading to the U.S. and Europe. People who previously had never heard of Ebola were clamoring, do something, do something! Seemingly overnight, the previous wallflower Ebola vaccine had become the prom king or queen or at least someone invited to the prom. Merck then entered the picture to subsequently take the Canadian vaccine to the finish line and approval.

Having a major regulatory body like the European Commission approve the vaccine is a major step towards other regulatory bodies around the world following suit. The U.S. Food and Drug Administration (FDA) is currently reviewing Mercks application for approval. So stay tuned for news from the FDA by the first quarter of 2020 about possible approval in the United States.

The Ebola vaccine approval is a major public health success. As history has shown, the advent of a vaccine can dramatically dampen the spread of an infectious disease, in many cases taking it from a clear and present danger to something that people dont have to worry about on a regular basis. Just look at what happened to measles after the measles vaccine was introduced. Actually, just look at what happened to measles at least until 2000, before some people thought that it would be good idea to tell people to stop getting vaccinated.

Ervebo wont be a blockbuster money maker for Merck. Vaccines typically are far from the most profitable products for pharmaceutical companies, and the Ebola virus is far from common in higher income countries. Thus, the global health community will need to find ways to support and fund use of this vaccine. Alas, the Ebola vaccine will continue to face this and other obstacles after approval such as finding ways to get people vaccinated. Nevertheless, this approval news is still a big times big to the biggeth power step forward.

Read the original:
The Ebola Vaccine Is Now Officially Here With Approval In Europe - Forbes

Wei Jian Gohs startup Craft Health makes personalized medicine and nutrition possible. The startup is one Im very envious of as Ive had a lot of ideas in this area for years. Ideas are nothing however and the Singapore based Craft Health team is executing on a series of innovations that could make personalized nutrition and medicine more accessible and widespread. Craft Health is taking a very straightforward and logical idea to market: one pill does not fit all. If were both adults and we take a painkiller we may each take one, as prescribed. But I may be twice as heavy as you or my body could have a completely different in many different ways. Craft Health wants to enable the customization of pills and doses to the individual. Whats more the company wants to make their custom 3D printed pills commonplace. On top of that, the team have spotted a huge application which no one is working on in 3D printing: 3D printed nutrition and supplements. Craft Health is a very exciting startup to me that could really unlock many exciting outcomes for people in all sorts of scenarios. I love that it was started by pharmacists to enable them to better help patients. Im very bullish on the Singaporean startup so we interviewed Wei Jian Goh who is a co-founder and the CEO of the startup.

What is Craft Health?

Craft Health is a personalized nutrition and medicines platform, leveraging onto 3D printing technologies. Our vision is to simplify the process of pill taking for consumers or patients.

Where do you hope to be in five years?

We aim to be at the forefront of the intersection for 3D printing technologies and formulations, supplying the Craft Health solutions to both nutraceuticals and pharmaceutical industries.

CraftHealths CO-Founders, both Pharmacists, Wei Jiang Goh and Seng Han Lim.

What do you do?

Using 3D printing, we are able to print different shapes, layers or geometries to provide accurate dosing of active ingredients such as nutraceuticals or active pharmaceutical ingredients. We also compartmentalize individual active ingredients to reduce the risk of cross contamination or interactions. .

At the same time, we are also formulation scientists and have formulated different bases for various controlled release profiles.

These include immediate release (active ingredients are released within 10 minutes of consumption), sustained release (active ingredients are slowly released between 4-6 hours after consumption), amongst others.

We are also developing our very own 3D printer, using the paste extrusion technique where no heat nor UV curing is used. We are looking at how we can automate the 3D printing process in a scalable manner.

In short, we are able to personalize the nutrition or medicines to the consumer/patient.

How does it work?

Craft Health uses a proprietary blend of generally regarded as safe (GRAS) materials that are already found in the pills that are commercially available. We take the non-active ingredients of these pills and change their ratio in order to achieve different formulations of controlled release. For example, we have formulations for immediate release (release of active ingredients within 10 minutes after consumptions) and sustained release (release of active ingredients slowly over a period of 4 -6 hours). The active ingredient is blended into our proprietary formulations.

The active ingredients and our proprietary formulation for the selected release profile are blended and formed into a paste. The semi-solid paste is then extruded into the shape of a pill using a 3D printer. We are able to print multiple active ingredients, each with their selected release profiles, within the same pill in this way.

What would determine the individual supplements?

The individual supplements would be determined by the individual, on the basis of what they want (self-selection) and what they need (depending on their response for nutritional questionnaires and even nutrigenomics)

Would it depend on me, or me at one point, my blood work?

This would depend largely on the extent of personalization you require, from filling up a simple questionnaire to nutrigenomics.

Who are your customers?

Craft Health is targeting nutraceuticals and pharmaceutical companies to

1. License our technologies and 3D printed formulation solutions

2. Supply our 3D printed pills through the Craft Health Platform

What benefits would they have?

Nutraceuticals: Increase the product range to consumers, especially discerning consumers who are increasingly concerned about what supplements they take. Supplements can be in various combinations personalized to the individual, and also release profiles.

Pharmaceuticals: Rapid prototyping for reformulation exercise to extend existing patent life spans of therapeutics, or a low volume, high mix approach to clinical trials where small volumes batches and dosing can be titrated quickly, depending on the trial results.

Why did you start this company?

Craft Health is founded by two Singaporean pharmacists, who went on to pursue our PhDs in 3D printing and formulation work.

When we were practising as pharmacists, we saw many instances where patients go home with bags of medicines, typically from common conditions such as hypertension, diabetes and high cholesterol. This is further exacerbated by complicated dosing regimens such as before/after food requirements. We thought that there should be a better solution to this, something that can simplify the process of medicine taking and this, was the inspiration for Craft Health.

Who has funded you?

Craft Health has recently closed their seed fund raising round led by Mistletoe Singapore, and participated by National University of Singapore (NUS) Graduate Research Innovation Programme (GRIP) and one angel, NUS Adjunct Associate Professor Neo Kok Beng.

What does it feel like to be the first company in 3D printed nutrition?

We believe we are the first company in 3D printed nutrition in South East Asia. It is a humbling experience as we learn about the various nuances of consumer preferences in this region.

Do you think that 3D printed nutrition is for everyone? or just a select group of athletes?

We believe the early adopters will be those that require highly specialized nutrition. These include athletes where age, gender, sports type and even the stage of training matters. Eventually we see 3D printed nutrition for everyone, whether for maintaining good health or to optimize their performance.

When do you hope to launch a customer?

We are an early stage start up, having incorporated in May 2019. Currently we are in the research and development phase, where we are expanding our database of various formulations, developing our in-house 3D printer and also actively looking for collaborations and partnerships. Our target launch for our initial pilot for 3D printed supplements would be late 2020.

What magical sauce do you have that would stop me from copying you?

We believe we are one of the few companies that are developing the complete supply chain for 3D printed healthcare: From developing our very own 3D printers specializing in 3D printing nutraceuticals and pharmaceuticals, to developing our proprietary database of various formulations for controlled release of different active ingredients, whether supplements or pharmaceuticals. Therefore, we are able to offer a one stop solution for 3D printed healthcare.

Discuss this article and more on the 3DPrintBoard or comment below to tell us what you think.

See the article here:
Interview with Wei Jian Goh of Craft Health on Personalized Medicine and Nutrition - 3DPrint.com

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NEC and VAXIMM announce collaboration to advance personalized neoantigen cancer vaccines - Pharmaceutical Business Review

PARSIPPANY, NJ, Nov. 12, 2019 (GLOBE NEWSWIRE) -- Interpace (IDXG) announced today that it will report its third quarter 2019 financial results on Wednesday, November 13, 2019 at 4:30 p.m. ET. Interpace will host a conference call and webcast to discuss the Companys financial results and provide a general business update.

All listeners should confirm they are dialing in for the Interpace conference call with the operator who will promptly place them into the call. A webcast replay will be available on the companys website (www.interpacediagnostics.com) approximately two hours following completion of the call and will be archived on the companys website for 90 days.

About Interpace, Inc.

Interpace is a leader in enabling personalized medicine, offering specialized services along the therapeutic value chain from early diagnosis and prognostic planning to targeted therapeutic applications.

Interpaces Diagnostic Business is a fully integrated commercial and bioinformatics business unit that provides clinically useful molecular diagnostic tests, bioinformatics and pathology services for evaluating risk of cancer by leveraging the latest technology in personalized medicine for improved patient diagnosis and management. Interpace has four commercialized molecular tests and one test in a clinical evaluation process (CEP): PancraGEN for the diagnosis and prognosis of pancreatic cancer from pancreatic cysts; ThyGeNEXT for the diagnosis of thyroid cancer from thyroid nodules utilizing a next generation sequencing assay; ThyraMIR for the diagnosis of thyroid cancer from thyroid nodules utilizing a proprietary gene expression assay; and RespriDXthat differentiates lung cancer of primary vs. metastatic origin. In addition, BarreGEN for Barretts Esophagus, is currently in a clinical evaluation program whereby we gather information from physicians using BarreGEN to assist us in positioning the product for full launch, partnering and potentially supporting reimbursement with payers.

Interpaces Biopharma Business is a market leader in providing pharmacogenomics testing, genotyping, and biorepository services to the pharmaceutical and biotech industries. The Biopharma Business also advances personalized medicine by partnering with pharmaceutical, academic, and technology leaders to effectively integrate pharmacogenomics into their drug development and clinical trial programs with the goals of delivering safer, more effective drugs to market more quickly, and improving patient care.

For more information, please visit Interpaces website at http://www.interpacediagnostics.com.

Forward-looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, relating to the Company's future financial and operating performance. The Company has attempted to identify forward looking statements by terminology including "believes," "estimates," "anticipates," "expects," "plans," "projects," "intends," "potential," "may," "could," "might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company's control. These statements also involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from those expressed or implied by any forward-looking statement. Additionally, all forward-looking statements are subject to the Risk Factors detailed from time to time in the Company's most recent Annual Report on Form 10-K and Quarterly Reports on Form 10Q. Because of these and other risks, uncertainties and assumptions, undue reliance should not be placed on these forward-looking statements. In addition, these statements speak only as of the date of this press release and, except as may be required by law, the Company undertakes no obligation to revise or update publicly any forward-looking statements for any reason.

CONTACTS:Investor Relations - Edison GroupJoseph Green(646) 653-7030jgreen@edisongroup.com

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Interpace to Host Conference Call and Webcast to Discuss Third Quarter 2019 Financial Results on Wednesday, November 13, 2019 - GlobeNewswire

In the fall of 2017, Brandi Bryant had a nagging cough. It seemed mild enough that it would go away on its own, but she began to worry when she also started experiencing shortness of breath.

It was a tiny bit annoying, Bryant, 41, of Atlanta, told TODAY. Nothing that really bothered me or a cough so bad like bronchitis.

Bryant suspected she had developed asthma. But, the doctors thought it might be pulmonary fibrosis, a lung disease that causes scarring, which makes it difficult to breath. She tried to research it, but her symptoms didnt seem to fit.

Dr. Google said it was cancer," she said. "But, it didnt make any sense for me."

I was exercising OK, I was able to do everything, like running after my children, Bryant added. Even the pulmonologist said in the first appointment, This isnt cancer ... Its got to be something else.

Her doctors kept searching. They ordered a CT scan and followed up with a bronchoscopy to look directly into her airways. By this point, Bryant wondered if she had a disease like tuberculosis or even worse.

When she returned to look at the results, she sensed the doctor seemed sober. That's when she was told she had stage 3B lung cancer.

Bryant was stunned by the news, in part because she never smoked. She calls herself the judgiest of judges when it comes to smokers.

Trending stories,celebrity news and all the best of TODAY.

I run away when I see people smoking ... I didnt understand why you cant stop smoking, she said. "To have a cancer that we have been told that its only cause is smoking, I was blown away. I was completely devastated.

She started chemotherapy and radiation, but after her fourth round of chemotherapy she developed fluid around her heart and lungs. When doctors drained the fluid, they found it had cancer in it, too, and Bryant now had stage 4 cancer. Genomic testing revealed that it was anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer. People under 55 who never smoked are most likely to have this form of cancer, according to the Lung Cancer Foundation of America.

Going from stage 3, hoping for a cure, to stage 4 and you are incurable until you die ... It was overwhelming, she said. It was really, really tough.

Looking back, Bryant had thought her symptoms seemed mild, but her ex-husband mentioned months before her diagnosis that she coughed throughout the night. It hadnt been disrupting her sleep or how she felt, so she thought it was something small and never sought help for it.

I was so busy and taking care of the family. It didnt bother me, Bryant explained. It was not a priority. It is what we as women do.

Breaking the news about the cancer to her four children Amelie, 17, Karsyn, 11, Gabrielle, 9, and Ken, 5 was tough.

The hardest things, of course, was telling them, she said. The first thing my second daughter asked me was, Are you going to die? The hardest thing was me saying that I cant promise her. I dont know.

For a year and a half, Bryant has been on a therapy that targets the ALK mutation and has shrunk her tumors, meaning that, for now, there's no detectable cancer in her body.

The focus of lung cancer treatments is to stop it from spreading, according to Dr. D. Ross Camidge, director of thoracic oncology and the Joyce Zeff Chair in Lung Cancer Research at the University of Colorado Cancer Center, who did not treat Bryant.

"If the cancer has spread to other organs ... control, not cure, is the goal, he told TODAY via email. For some subtypes of lung cancer, like ALK, that control can be measured in years.

Expanded treatment options like genomic testing and targeted therapy are giving lung cancer patients better chances, Camidge added.

"Lung cancer is not one disease anymore, he said. Dividing it into different [types], based on the cancers genes, has been the key to the success of personalized medicine. Long-term control is much easier when you are individualizing treatment approaches to each patient.

For Bryant, she knows that the effects of her therapy are likely to last about three years and that treatment options are limited beyond this step. She hopes that sharing her story will help increase resources to investigate all lung cancers.

I am hoping we can do some more research and have more than one option available, she said.

Throughout her treatment, Bryant has continued to work and enjoy time with her family. She adopted a dog and took her children to Paris.

Im definitely more of a live-in-the-moment person, I realize that life is fragile for all of us," she said. "We just dont realize until it touches you in some way, where there is some kind of tragedy or you have a diagnosis that is life limiting."

Even though her future remains unclear, she stays positive and is making memories: The biggest thing I have done is I am present with my children."

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Nonsmoking mom thought she had asthma, it was lung cancer - TODAY

A novel method to improve outcomes of surgery to treat epilepsy has now received approval for clinical testing in 13 French hospitals. The approach could provide a better therapeutic perspective against the drug-resistant form of the disease, which constitutes one-third of all cases, and is a development by Human Brain Project scientist Viktor Jirsa and an interdisciplinary team of collaborators.

To help clinicians plan surgery strategies, the scientists created personalized brain models of patients and simulate the spread of abnormal activity during epileptic seizures. The method represents the first example of a personalized brain modeling approach entering the clinic and will now be assessed over four years in a cohort of 356 patients under strict requirements.

How do we currently treat epilepsy?

Epilepsy is a wide-spread neurological disorder that affects around 50 million people worldwide. In many cases, the seizures that mark the disease can be controlled by drugs, but close to a third of all patients are drug-resistant. For them, the only remaining option is surgical removal of the epileptogenic zone, the area from which the seizure activity first emerges and then spreads. During surgery preparation it is critical to localize this area as precisely as possible in the brain, but very challenging with current methods. As a result, surgery outcomes are difficult to predict, with success rates of only around 60%.

This low success rate has largely stayed the same for the last 30 years. We hope our approach can finally improve the odds for patients, says Jirsa. In the Human Brain Project, Jirsa is the Deputy Leader of the research area of Theoretical Neuroscience.

The Human Brain Project and The Virtual Brain

Over the last five years and in large part within the framework of the Human Brain Project, Jirsa and his team worked on an approach that could bring a change. The team has adapted the open network simulator The Virtual Brain towards applications in epilepsy. This work has laid foundations for the project EPINOV, short for Improving EPilepsy surgery management and progNOsis using Virtual brain technology, a consortium coordinated by Fabrice Bartolomei (Hpital de la Timone) that brings together theorists like Jirsa, clinical neuroscientists, in particular from Marseille and Lyon, and the industry partner Dassault Systmes.

After two pilot studies showed promising results for the approach, the EPINOV-consortium has received approval from the French regulatory authority to put their approach to the test in a full-scale multi-centric trial with almost 400 prospective patients.

It represents the worlds first clinical trial ongoing using full brain network modeling, says Jirsa. When the authorization came in, it was like a huge pressure was relieved from me after all this hard work. Then followed last preparations to assure that all steps in the workflow of virtualization and evaluation of the patient brains are in order during the four-year period of the trial.

Bartolomei explains "This type of epilepsy affects millions of patients worldwide. The personalized modeling of epilepsy networks in drug-resistant patients is an innovative and scientifically validated approach, which proposes to enrich the interpretation of neurophysiological and neuroimaging tests, and thus to improve the surgical prognosis of epilepsy in an individualized way".

Jirsa and his close collaborators, Randy McIntosh at Baycrest Center Toronto and Petra Ritter at Charit Berlin, started building The Virtual Brain as an open-source brain network simulation engine from 2010 on, using neuronal population models and structural information from neuroimaging.

In the Human Brain Project environment, the conditions were perfect to go the decisive steps further towards applying it in a clinical context. The science underlying this trial is almost entirely a result of our work in the HBP, Jirsa says.

Simulating epilepsy

First, a personalized brain model is created from data on the individually measured anatomy, structural connectivity and brain dynamics for each patient. Through a series of steps, it is turned into a dynamic model, on which the seizure propagation can be simulated. High-Performance Computing enables the personalization of the brain network models through the application of machine learning.

The resulting brain avatar is customized to the individual patient and allows testing and estimating during surgery preparation. In a small cohort of retrospective surgery patients we were able to demonstrate that the predictions of the patients brain model correlate well with positive surgery outcome, Jirsa explains, and other labs have confirmed our results independently.

In half of the cases, the surgeons will have information from the epilepsy-model in their staff meetings, where therapeutic interventions are planned. It's a blind random design, half of these patients will be operated taking our model predictions into account, the other half will not. After four years, the statistics will show us hopefully to what degree the model predictions changed the surgery practice, results, and outcome, Jirsa says.

Within the EPINOV consortium, the industrial partner Dassault Systmes will develop a virtual brain-based simulation software prototype that could subsequently be provided to clinics worldwide. Headquartered in France, Dassault Systmes is a multinational software company focused on 11 industries including life sciences and the development of patient-centric modeling and simulation experiences.

There is a very big responsibility, Jirsa emphasizes and at the same time its very exciting that we have this chance to improve clinical practice and ultimately patients lives. And if the approach succeeds, it would also be the first modelling-based example of personalized medicine that makes the jump from research to clinical practice so the outcome will certainly be a signal to the field.

Katrin Amunts, Scientific Research Director of the Human Brain Project, highlights the significance of the move into the clinic: This breakthrough by Viktor Jirsa and his colleagues is a fantastic example of a new type of technology-enabled computational neuro-medicine. It is one of our central aims to catalyze developments like this that make concrete contributions in the fight against brain diseases to benefit patients.

Philippe Ryvlin, who leads the Medical Informatics Platform in HBP and the epilepsy surgery section of the European Reference Network EpiCARE emphasizes that this clinical trial, which will be the largest randomized study ever performed in epilepsy surgery, demonstrates that simulation of the human brain, as developed in HBP, has now reached a stage where it can be readily applied to address unmet medical needs.

Virtual Brain Researchers are also continuing their activities on clinical modeling for stroke and Alzheimers in collaboration with experts that the HBP brings together. For Jirsa seeing his work as a theoretical scientist gain this potential impact has been the result of a unique convergence: That we have come to this point was made possible by clinical expertise and our activities on The Virtual Brain and the Human Brain Project all coming together right place, right time, right people."

Reference

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

Originally posted here:
Simulation-based Method To Target Epilepsy Goes to Clinical Trials - Technology Networks

The biggest difficulty when treating cancer in the brain is the blood-brain barrier, a group of blood vessels that filter what enters and leaves the brain.

When cancer cells enter the brain, the blood-brain barrier becomes a blood-tumor barrier, which creates another obstacle for effectively getting cancer drugs to the brain.

A team at Purdue has developed an extensive identification of the blood-brain and blood-tumor barriers that interfere in brain metastases of lung cancer, which will provide a guide for developing treatments. The research was published in Oncotarget, a bio-medical journal that primarily publishes research on oncology.

Tiffany Lyle, an assistant professor in the College of Veterinary Science, led the team of scientists. Her work is centered on the pathology of the blood-brain barrier.

Brain metastases occur most frequently in patients diagnosed with breast and lung cancer and melanoma, Lyle said in a Purdue press release. She went on to explain that the metastases have a high survival rate, mainly because the blood-barrier makes it extremely difficult to get medication into the brain tissue.

Brain metastases, also known as secondary brain tumors, develop when cancer cells spread from their point of origin and into the brain. This is occurs in between 10% and 30% of adult cancer cases, according to the Mayo Clinic.

The researchers analyzed blood-brain and blood-tumor barriers in animal models using non-small-cell cancer cells, which make up the majority of lung cancers, and immunofluorescent imaging. They confirmed their results by studying blood-tumor barriers of brain metastases in brain tissue from cadavers.

We wanted to see what changes in the blood-brain barrier were occurring rapidly and which ones were sustained over time, Lyle said. Identifying those changes and pinpointing when they occur during the transition will be critical to developing treatment plant and being able to identify where, and when, cancer cells need to be targeted.

Lyle added that until the teams discovery, the blood-tumor barrier had not been properly identified in lung cancer.

During their analysis, the team observed that one of the changes in the blood-brain barrier to the blood-tumor barrier occurred in the astrocytes, one of the largest cells in the brain that serve a variety of functions. Lyle commented that this discovery alone will serve a key role in the development of future cancer treatment in the brain, as it shows the scientists where and when the brain prevents drugs from entering.

A goal of our research is to meaningfully contribute to the evolving field of personalized medicine and provide patients who have received a devastating diagnosis a sense of home for treatment possibilities, Lyle said.

More here:
Purdue researchers develop map to make getting cancer drugs to the brain easier - Purdue Exponent

NEW YORK, Nov. 11, 2019 /PRNewswire/ --Cohen Veterans Bioscience (CVB), a nonprofit research organization dedicated to fast-tracking personalized diagnostics and therapeutics for brain health, today announced its strategic collaboration with Parexel Biotech, a new division of Parexel, for CVB's adaptive platform trial evaluating pharmacotherapeutics to treat posttraumatic stress disorder (PTSD).

Parexel Biotech will provide clinical trial implementation services over a multi-year period beginning in October 2019. "We are delighted to be part of this important adaptive platform trial exploring a precision medicine approach for the treatment of PTSD," says Parexel CEO Jamie Macdonald. "We look forward to partnering with CVB on this innovative trial design in the brain disorders arena and to contributing to this important new therapy, which has significant potential to benefit patients."

In September 2018, CVB was granted a research award by Advanced Technology International (MTEC Consortium Manager) on behalf of the U.S. Army Medical Research Development Command (MRDC). The award is for a 3.5-year clinical trial to test the efficacy and safety of pharmaco-therapeutics for PTSD via a well-powered adaptive platform trial (APT). CVB will lead this program and serve as the Clinical Coordinating Center (CCC), establishing a clinical trial infrastructure operating within the trial's governance structure. A government Joint Steering Committee (JSC) is a part of the governance structure and includes representatives from the Veterans Health Administration (VA), the National Institute of Mental Health, National Institute of Alcohol Abuse and Alcoholism, the Food and Drug Administration (FDA), and the Defense Health Agency's Psychological Health Center of Excellence. For more information read the press release here.

This Phase 2 adaptive clinical trial is scheduled to start in the Fall of 2020 and during the period of performance, at least two active drugs (pending selection) will be evaluated. Biological measurements will be incorporated to support a precision medicine approach to PTSD treatment. A goal of this trial is to identify a drug to advance to Phase 3 testing starting in 2022, and ultimately lead to an additional FDA-approved drug for the treatment of PTSD.

Parexel Biotech is Parexel's dedicated division to support emerging biotech companies in reaching their drug development and commercialization goals quickly and cost-effectively, building on the Company's heritage of clinical, regulatory, commercial and technology expertise with enhanced strategic consulting and asset development capabilities.

"In our selection of Parexel Biotech to conduct this program, which has far-reaching implications for the field, we focused on their world-class reputation, proven track record of delivery and highly-flexible partnership approach," says Magali Haas, CEO & President of Cohen Veterans Bioscience.

About Posttraumatic Stress Disorder (PTSD) PTSD is a mental health condition that some people develop after experiencing or witnessing a violent or life-threatening event, such as combat, natural disaster, terrorist attack, or sexual assault. Symptoms of PTSD can include reliving the event or having flashbacks; avoiding situations that trigger the memories; losing interest in activities or feelings of fear, guilt, or shame; feeling anxious or always on alert for danger. PTSD affects about 8.6 million American adults each year and is the fifth most prevalent mental disorder in the United States. Overall prevalence rates among veterans of different conflicts range from 10-30% (OEF/OIF/OND/Gulf War/Vietnam).

The only approved medications for the treatment of PTSD are the selective serotonin reuptake inhibitors (SSRIs) sertraline (Zoloft) and paroxetine (Paxil) approved nearly 20 years ago.

The Department of Veteran Affairs (VA) 2017 Consensus Statement of the PTSD Psychopharmacology Working Group concluded that there is a deficient pipeline of new PTSD medications and an assessment of recent trial failures has generated concerns about how to best identify new targets for medication development and optimally design clinical studies. In a highly heterogeneous patient population such as PTSD, the availability of validated biomarkers or companion diagnostics would allow clinicians to predict the likelihood that a given patient would respond to a given therapeutic, enabling individualized medicine for these conditions. No biomarkers have been qualified nor cleared as companion diagnostics for PTSD by the FDA.

CVB will be spearheading the design and application of "Smart-" or "Adaptive-" clinical trials for PTSD. These studies include a prospectively planned opportunity for modification of one or more specified aspects of the study design based on data (usually interim data) collected from subjects in the study. To execute such a program, a centrally-managed platform clinical trial infrastructure will be established, potentially including academic, private, VA, and military research centers.

About Cohen Veterans BioscienceCohen Veterans Bioscience is a nonprofit 501(c)(3) research organization dedicated to fasttracking the development of diagnostic tests and personalized therapeutics for the millions of veterans and civilians who suffer the devastating effects of trauma-related and other brain disorders. We are creating a paradigm shift in how we approach and treat brain health by utilizing cutting-edge technologies to establish enabling platforms and implementing our end-to-end catalytic operating model in translational science, clinical programs, data science, and digital health to advance personalized and precision medicine. To support & learn more about our research efforts, visit http://www.cohenveteransbioscience.org.

About Parexel Parexel is focused on supporting the development of innovative new therapies to improve patient health. We do this through a suite of services that help life science, biopharmaceutical and biotech customers across the globe transform scientific discoveries into new treatments for patients. From clinical trials to regulatory and consulting services to commercial and market access, our therapeutic, technical and functional ability is underpinned by a deep conviction in what we do. For more information, visit our website and follow us on LinkedIn, Twitter and Instagram.

Parexel is a registered trademark of Parexel International Corporation. All other trademarks are the property of their respective owners.

Media Inquiries: Cohen Veterans Bioscience Nicole Harmon media@cohenbio.org

Parexel Wendy Ryan Tel.: +1 781-434-5104 Email: Wendy.Ryan@parexel.com

View original content to download multimedia:http://www.prnewswire.com/news-releases/cohen-veterans-bioscience-and-parexel-biotech-collaborate-on-landmark-adaptive-platform-trial-studying-posttraumatic-stress-disorder-ptsd-pharmacotherapeutics-300955790.html

SOURCE Cohen Veterans Bioscience

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Cohen Veterans Bioscience and Parexel Biotech Collaborate on Landmark Adaptive Platform Trial Studying Posttraumatic Stress Disorder (PTSD)...

Company News

Hrsholm, Denmark (12 November 2019) Oncology Venture A/S (OV or the Company) today announced an update on the progress of its ongoing U.S. Phase 2 clinical trial for its PARP inhibitor, 2X-121, for the treatment of ovarian cancer, sited at the Dana-Farber Cancer Institute (Boston, MA, U.S.A.).

The cancer drug 2X-121 (formerly E7449) is a small molecule, targeted inhibitor of Poly ADP-Ribose Polymerase (PARP), a key DNA damage repair enzyme active in cancer cells, which was originally developed by the pharmaceutical company Eisai. The company has recently announced this drug as one of its top priority programs.

2X-121 is currently being evaluated for the treatment of advanced ovarian cancer in a DRP-guided Phase 2 clinical trial at the Dana-Farber Cancer Institute (Boston, MA U.S.A.). Thus far, 8 patients are enrolled in the study, with ongoing enrollment towards a target of 30 patients. The Company is opening a second trial site, at Guys Hospital (London, UK) to accelerate patient accrual to the trial. Guys Hospital was the site of the prior Phase 1 study of 2X-121 under sponsorship by Eisai. Through use of DRP patient selection, OV aims to provide a superior clinical benefit, to ovarian cancer patients receiving 2X-121, as compared to other approved PARP inhibitors. The global PARP inhibitor market is projected to reach USD 9 billion by 2027 in ovarian cancer.

Steve R. Carchedi, CEO of Oncology Venture, commented We are excited to announce the ongoing progress of our key Phase 2 clinical trial for 2X-121 at one of the worlds leading cancer and personalized medicine centers. The approval and use of PARP inhibitors for the treatment of a variety of cancers is an exciting area that is rapidly expanding, and we are confident our Phase 2 study will prove the merits of our drug, together with its DRP companion diagnostic, as we advance towards approval and commercialization of this priority asset in our pipeline.

For further information, please contact:

About Oncology Venture A/SOncology Venture A/S is engaged in the clinical development towards commercialization of anti-cancer drugs in a precision medicine approach utilizing a proprietary Drug Response Predictor (DRP) platform technology to significantly increase the probability of success in clinical trials and the improvement of patient outcomes. DRP is a best-in-class predictive biomarker (companion diagnostic) technology that has proven its ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients in nearly 40 clinical studies that were examined, and is currently demonstrating promising prospective results in an ongoing phase 2 study of LiPlaCis for metastatic breast cancer. DRP enables the selection and treatment of highly likely responder patients to a given cancer drug, thus substantially increasing the likelihood of clinical trial success and improved patient outcomes, as compared with traditional pharmaceutical development. DRP enables selection of a more well-defined patient group, leading to decreased risks and costs while the development process becomes more efficient, and patient outcomes become improved.

The current OV product portfolio includes seven cancer drugs: 2X-121 -- a PARP inhibitor in an ongoing Phase 2 for ovarian cancer; Dovitinib -- a post Phase 3 product, being prepared for a US NDA approval filing in renal cell carcinoma (RCC); IXEMPRA (Ixabepilone) an approved and marketed (U.S.) microtubule inhibitor being advanced for Phase 2 development (in EU) for treatment of breast cancer; LiPlaCis -- a liposomal formulation of cisplatin in an ongoing Phase 2 trial for breast cancer 2X-111 a targeted, liposomal formulation of doxorubicin staged for Phase 2 development for the treatment of brain metastases of breast cancer; Irofulven a DNA damaging agent in an ongoing Phase 2 trial in prostate cancer; and APO010 - an immuno-oncology product staged for Phase 2 development for the treatment of multiple myeloma. The Companys current priority program focus is for advancement of 2X-121, IXEMPRA, and Dovitinib.

Learn more at oncologyventure.com

Follow us on social media:Facebook:https://www.facebook.com/oncologyventure/LinkedIn:https://www.linkedin.com/company/oncology-venture/Twitter:https://twitter.com/OncologyVenture

Forward-looking statementsThis announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of OVs control and which could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning OVs plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. OV undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law.

Certified Adviser: Svensk Kapitalmarknadsgranskning AB, Email: ca@skmg.se. Tel: +46 11 32 30 732

This information is information that Oncology Venture A/S is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication on November 12, 2019.

Original post:
Oncology Venture advancing towards next milestone in its clinical development of 2X-121. - GlobeNewswire

Google is involved with one of the U.S.s major healthcare systems on a venture to collect and crunch the comprehensive personal-health information of millions of people within 21 states. The project between Google and Ascension (the countrys second-largest hospital system) announced the data collection is for the improvement of medical services. The collaboration, code-named Project Nightingale, began in secret last year, according to the reports.

The Catholic, non-profit has more than 34,000 providers and operates in 20 states and District of Columbia with 150 hospitals running all over these states. Under the agreement, Ascension patients data is eventually uploaded to Googles cloud computing platform. The publication adds that as many as 150 Google staff may have had access to the data and that some could have downloaded it.

The collaboration will give Google access to datasets that could help it tune its potentially beneficial artificial intelligence (AI) tools. Ascension said in a statement the agreement would also explore artificial intelligence and machine learning applications to help improve clinical effectiveness, along with patient safety. Many called for an instant change to privacy laws after Google Ascension partnership, the healthcare business it has combined with, boasted that the venture is completely legal.

Dr. Robert Epstein, an author, medical researcher and former editor-in-chief at Psychology Today, summed up the mood when he tweeted: You cant make this s*** up. #BeAfraid. At the time of the acquisition, many of the companys 28million users announced they were throwing their devices away for fear of Google getting its hands on potentially sensitive medical information. The company formerly had hyped smaller healthcare clients, such as the Colorado Center for Personalized Medicine.

The Google Cloud CEO, Thomas Kurian, has made it a main concern in his first year on the job to relentlessly chase business from leaders in six industries, including healthcare. Google recently announced plans to buy Fitbit Inc. for $2.1bn, aiming to enter the wearables market and invest in digital health.

Link:
Google and Ascension Partners on 'Project Nightingale' to Collect Healthcare Data in US - News Obtain

Predictive Analytics and Comparative Effectiveness (PACE) Center, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts (D.M.K., J.K.P., J.B.W.)

Erasmus Medical Center, Rotterdam, the Netherlands, and Predictive Analytics and Comparative Effectiveness (PACE) Center, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts (D.V.)

Boston University, Boston, Massachusetts (R.D.)

Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, California (S.G., J.P.I.)

University of Michigan, Ann Arbor, Michigan (R.H.)

Duke Clinical Research Institute, Duke University, Durham, North Carolina (B.P., M.P.)

Virginia Polytechnic Institute and State University, Blacksburg, Virginia (S.M.)

Center for Clinical Evidence Synthesis, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts (G.R.)

Schools of Medicine and Public Health, Yale University, New Haven, Connecticut (J.S.R.)

Center for Cardiovascular Health Services Research, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, and Tufts Clinical and Translational Science Institute, Boston, Massachusetts (H.P.S.)

Center on Aging and Health, Johns Hopkins University, Baltimore, Maryland (R.V.)

Memorial Sloan Kettering Cancer Center, New York, New York (A.V.)

Leiden University Medical Center, Leiden, the Netherlands (E.W.S.)

Disclaimer: The views, statements, and opinions presented in this work are solely the responsibility of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI), its Board of Governors, or its Methodology Committee.

Acknowledgment: The authors thank Mark Adkins, Teddy Balan, and Dan Sjoberg for excellent technical support in analyses included in the figures and supporting appendix tables. They also thank the Annals of Internal Medicine editors and reviewers, whose thoughtful feedback greatly improved this work. They thank Jennifer Lutz and Christine Lundquist for assistance with copyediting and creating exhibits.

Financial Support: Development of the PATH Statement was supported through contract SA.Tufts.PARC.OSCO.2018.01.25 from the PCORI Predictive Analytics Resource Center. This work was also informed by a 2018 conference (Evidence and the Individual Patient: Understanding Heterogeneous Treatment Effects for Patient-Centered Care) convened by the National Academy of Medicine and funded through a PCORI Eugene Washington Engagement Award (1900-TMC).

Disclosures: Dr. Kent reports grants from PCORI during the conduct of the study. Dr. Hayward reports grants from the National Institute of Diabetes and Digestive and Kidney Diseases and the Veterans Affairs Health Services Research and Development Service during the conduct of the study. Dr. Pencina reports grants from PCORI (Tufts Subaward) during the conduct of the study; grants from Sanofi/Regeneron, Amgen, and Bristol-Myers Squibb outside the submitted work; and personal fees from Boehringer Ingelheim and Merck outside the submitted work. Dr. Ross reports personal fees from PCORI during the conduct of the study and grants from the U.S. Food and Drug Administration, Medtronic, Johnson & Johnson, the Centers for Medicare & Medicaid Services, Blue Cross Blue Shield Association, the Agency for Healthcare Research and Quality, the National Institutes of Health (National Heart, Lung, and Blood Institute), and Laura and John Arnold Foundation outside the submitted work. Dr. Varadhan reports personal fees from Tufts University during the conduct of the study. Dr. Vickers reports grants from the National Institutes of Health during the conduct of the study. Dr. Wong reports grants from PCORI during the conduct of the study. Dr. Steyerberg reports royalties from Springer for his book Clinical Prediction Models. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at http://www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M18-3667.

Corresponding Author: David M. Kent, MD, MS, Predictive Analytics and Comparative Effectiveness (PACE) Center, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, 800 Washington Street, Box 63, Boston, MA 02111; e-mail, dkent1@tuftsmedicalcenter.org.

Current Author Addresses: Drs. Kent, Paulus, Raman, and Selker: Predictive Analytics and Comparative Effectiveness (PACE) Center, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, 800 Washington Street, Box 63, Boston, MA 02111.

Dr. van Klaveren: Erasmus University Medical Center, Doctor Molewaterplein 40, 3015 GD Rotterdam, the Netherlands.

Dr. D'Agostino: Boston University Mathematics and Statistics Department, 111 Cummington Street, Boston, MA 02215.

Dr. Goodman: Stanford University School of Medicine, 150 Governor's Lane, Room T265, Stanford, CA 94305.

Dr. Hayward: VA Ann Arbor Health Services Research and Development, 2800 Plymouth Road, Building 14, G100-36, Ann Arbor, MI 48109.

Dr. Ioannidis: Stanford Prevention Research Center, 1265 Welch Road, Stanford, CA 94305.

Ms. Patrick-Lake: Evidation Health, 167 2nd Avenue, San Mateo, CA 94401.

Dr. Morton: Virginia Tech, North End Center Suite 4300, 300 Turner Street NW, Blacksburg, VA 24061.

Dr. Pencina: Duke Clinical Research Institute, 200 Trent Street, Durham, NC 27710.

Dr. Ross: Yale University School of Medicine, PO Box 208093, New Haven, CT 06520.

Dr. Varadhan: Johns Hopkins University, Division of Biostatistics and Bioinformatics, 550 North Broadway, Suite 1103-A, Baltimore, MD 21205.

Dr. Vickers: Memorial Sloan Kettering Cancer Center, 485 Lexington Avenue, 2nd Floor, New York, NY 10017.

Dr. Wong: Tufts Medical Center, 800 Washington Street #302, Boston, MA 02111.

Dr. Steyerberg: Erasmus University Medical Center, PO Box 2040, 3055 PC Rotterdam, the Netherlands.

Author Contributions: Conception and design: D.M. Kent, J.K. Paulus, R. Hayward, J.P.A. Ioannidis, J.S. Ross, A. Vickers, J.B. Wong, E.W. Steyerberg.

Analysis and interpretation of the data: D.M. Kent, J.K. Paulus, R. D'Agostino, R. Hayward, J.P.A. Ioannidis, J.B. Wong, E.W. Steyerberg.

Drafting of the article: D.M. Kent, J.K. Paulus, R. D'Agostino, A. Vickers, J.B. Wong.

Critical revision of the article for important intellectual content: D.M. Kent, J.K. Paulus, D. van Klaveren, R. D'Agostino, R. Hayward, J.P.A. Ioannidis, S. Morton, M. Pencina, G. Raman, J.S. Ross, R. Varadhan, A. Vickers, J.B. Wong, E.W. Steyerberg.

Final approval of the article: D.M. Kent, J.K. Paulus, D. van Klaveren, R. D'Agostino, S. Goodman, R. Hayward, J.P.A. Ioannidis, B. Patrick-Lake, S. Morton, M. Pencina, G. Raman, J.S. Ross, H.P. Selker, R. Varadhan, A. Vickers, J.B. Wong, E.W. Steyerberg.

Provision of study materials or patients: D.M. Kent, J.B. Wong.

Statistical expertise: D.M. Kent, D. van Klaveren, R. D'Agostino, R. Hayward, J.P.A. Ioannidis, S. Morton, R. Varadhan, A. Vickers, J.B. Wong, E.W. Steyerberg.

Obtaining of funding: D.M. Kent, J.K. Paulus, J.B. Wong.

Administrative, technical, or logistic support: D.M. Kent, J.K. Paulus, G. Raman, H.P. Selker, J.B. Wong.

Collection and assembly of data: D.M. Kent, J.K. Paulus, G. Raman, J.B. Wong.

Read the original:
The PATH Statement - Annals of Internal Medicine

Since 2006, when Shinya Yamanaka, now the director of the Center for iPS Cell Research and Application at Kyoto University, discovered a method that could guide fully differentiated cells back to their pluripotent state, scientists have been using his recipe to produce induced pluripotent stem cells. The protocol relies on overexpressing the so-called Yamanaka factors, which are four transcription factors: Oct4, Sox2, Klf4, and cMyc (OSKM). While the technique reliably creates iPS cells, it can cause unintended effects, some of which can lead to cells to become cancerous. So researchers have worked to adjust the cocktail and understand the function of each factor.

No one had succeeded in creating iPS cells without forcing the overexpression of Oct4. It was thought that this was the most crucial factor of the four. At least until now.

If this works in adult human cells, it will be a huge advantage for the clinical applications of iPS cells.

Shinya Yamanaka, Kyoto University

Four years ago, Sergiy Velychko, a graduate student at the Max Planck Institute for Molecular Biomedicine in Hans Schlers lab, and his team were studying the role of Oct4 in creating iPS cells from mouse embryonic fibroblasts. He used vectors to introduce various mutations of the gene coding for Oct4 to the cells he was studying, along with a negative controlone that didnt deliver any Oct4. He was shocked to discover that even using his negative control, he was able to generate iPS cells.

Velychkos experiment was suggesting that it is possible to develop iPS cells with only SKM.

We just wanted to publish this observation, Velychko tells The Scientist, but he knew hed need to replicate it first because reviewers wouldnt believe it.

He and his colleagues, including Guangming Wu, a senior scientist in the lab, repeated the experiment several times, engineering vectors with different combinations of the four factors. SKMthe combination that didnt include Oct4was able to induce pluripotency in the cells with about 30 percent of the efficiency of OSKM, but the cells were of higher quality, meaning that the researchers didnt see evidence of common off-target epigenetic effects. They reported their results yesterday (November 7) in Cell Stem Cell.

Efficiency is not important. Efficiency means how many colonies do you get, explains Yossi Buganim, a stem cell researcher at the Hebrew University of Jerusalem, who was not involved in the study. If the colony is of low quality, the chances that eventually the differentiated cells will become cancerous is very high.

Finally, the team employed the ultimate test, the tetraploid complementation assay, in which iPS cells are aggregated with early embryos that otherwise would not have been able to form a fully functional embryo on their own. These embryos grew into mouse pups, meaning that the iPS cells the team created were capable of maturing into every type of cell in the animal.

Whats more is they found that the SKM iPS cells could develop into normal mouse pups 20 times more often than the OSKM iPS cells, suggesting that the pluripotency of iPS cells can be greatly improved by omitting Oct4 from the reprogramming factor cocktail.

The results will need to be verified in human cells, Buganim cautions. His team has developed methods for creating iPSCs that worked well in mouse cells only to be completely ineffective in humans.

Yamanaka himself was enthusiastic about the results, telling The Scientist in an email that his team would definitely try the method in other cell types, especially adult human blood cells and skin fibroblasts. If this works in adult human cells, it will be a huge advantage for the clinical applications of iPS cells.

S.Velychkoet al.,Excluding Oct4 from Yamanaka cocktail unleashes the developmental potential of iPSCs,Cell Stem Cell,doi:10.1016/j.stem.2019.10.002,2019.

Emma Yasinski is a Florida-based freelance reporter. Follow her on Twitter@EmmaYas24.

More:
Oct4, Considered Vital for Creating iPSCs, Actually Isnt Needed - The Scientist

HOUSTON, Nov. 12, 2019 /PRNewswire/ -- Marker Therapeutics, Inc.(Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today provided a corporate update and reported financial results for the third quarter ended September 30, 2019.

"We continue to make progress in advancing our next-generation T-cell based immunotherapies for the treatment of hematological malignancies and solid tumors," said Peter L. Hoang, President and CEO of Marker Therapeutics. "Our partner-sponsored MultiTAA T-cell therapy trials at the Baylor College of Medicine continue to show promising results. In addition, we continue to expand our team and build out our infrastructure to support future Marker-sponsored clinical trials. We expect the next 12 to 18 months to be an exciting and productive time for our Company."

Continued Mr. Hoang: "We recently filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for our MultiTAA T-cell therapy as part of a planned Marker Phase 2 study in post-allogeneic hematopoietic stem cell transplant patients with acute myeloid leukemia in both the adjuvant and active disease setting. The FDA reviewed our submission and requested additional information regarding certain quality and technical specifications for two reagents supplied by third party vendors that are used in our manufacturing process. Because the FDA requires these data in order to clear the IND, the Marker AML trial has been placed on clinical hold until our complete response to the technical questions is satisfactory to the FDA. While these reagents are not present in the final product, we worked with respective manufacturers of these reagents to satisfy the FDA's questions and subsequently submitted a complete response to the FDA in late October. We currently project to initiate our Phase 2 trial in 2020 and look forward to providing an update on our clinical path forward upon receiving the FDA's feedback."

PROGRAM UPDATES

Multi-Antigen Targeted (MultiTAA) T-Cell Therapies

Marker Submits Response to FDA Clinical Hold on AML Trial The Company worked with regulatory and quality groups at the respective manufacturers to address the FDA's request and submitted a complete response to the issues raised by the FDA on October 28, 2019. The FDA will respond within 30 daysafter receiving Marker's complete response, indicating whether the hold is lifted and, if not, specifying the reasons the clinical trial remains on hold.Marker expects to initiate its Phase 2 clinical trial of MultiTAA therapy for the treatment of post-transplant AML in 2020.

T Cell-Based Vaccines

Phase 2 Triple Negative Breast Cancer Trial ProgressingMarker continues to advance its T cell-based vaccine program in triple negative breast cancer. To date, results have shown:

Phase 2 Platinum-Sensitive Advanced Ovarian Cancer Trial Update Marker will be discontinuing the development of TPIV200 in patients with platinum-sensitive advanced ovarian cancer based on an unblinded review of interim results from its Phase 2 study conducted by an independent Data and Safety Monitoring Board (DSMB). Although the DSMB did not express any safety concerns with respect to TPIV200, Marker has elected to suspend the trial because it did not meet the threshold for probability of success based upon the Company's pre-specified criteria. Pending full review of the data, Marker anticipates closing the trial in the first quarter of 2020.

CORPORATE UPDATES

THIRD QUARTER 2019 FINANCIAL RESULTS

Net loss for the quarter ended September 30, 2019 was $5.5 million, compared to a net loss of $4.4 million for the quarter ended September 30, 2018.

Research and development expenses during the three months ended September 30, 2019 were $3.1 million, compared to $1.9 million during the three months ended September 30, 2018. The increase of $1.2 million was primarily attributable to increases in personnel-related expenses, relating to the build-up of Marker's internal infrastructure.

General and administrative expenses were $2.5 million during the three months ended September 30, 2019 as compared to $2.6 million during the three months ended September 30, 2018. The decrease was primarily attributable to $0.6 million of merger-related expenses incurred during the three months ended September 30, 2018, offset by increased expenses in headcount-related and legal and other professional expenses.

CASH POSITION AND GUIDANCE

At September 30, 2019, Marker had cash and cash equivalents of $48.5 million. The Company believes that its existing cash and cash equivalents will fund its current operations through at least the fourth quarter of 2020.

Conference Call and Webcast

The Company will host a webcast and conference call to discuss its third quarter 2019 financial results and provide an update on recent corporate activities today at 5:00 p.m. EST.

The webcast will be accessible in the Investors section of the Company's website at http://www.markertherapeutics.com. Individuals can participate in the conference call by dialing 877-407-8913 (domestic) or 201-689-8201 (international) and referring to the "Marker Therapeutics Third Quarter 2019 Earnings Call."

The archived webcast will be available for replay on the Marker website following the event.

About Marker Therapeutics, Inc.Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications. Marker's cell therapy technology is based on the selective expansion of non-engineered, tumor-specific T cells that recognize tumor associated antigens (i.e. tumor targets) and kill tumor cells expressing those targets. This population of T cells is designed to attack multiple tumor targets following infusion into patients and to activate the patient's immune system to produce broad spectrum anti-tumor activity. Because Marker does not genetically engineer its T cell therapies, we believe that our product candidates will be easier and less expensive to manufacture, with reduced toxicities, compared to current engineered CAR-T and TCR-based approaches, and may provide patients with meaningful clinical benefit. As a result, Marker believes its portfolio of T cell therapies has a compelling product profile, as compared to current gene-modified CAR-T and TCR-based therapies.

Marker is also advancing a number of innovative peptide and gene-based immuno-therapeutics for the treatment of metastatic solid tumors, including the Folate Receptor Alpha program (TPIV200) for breast cancer and the HER2/neu program (TPIV100/110) for breast cancer, currently in Phase 2 clinical trials.

To receive future press releases via email, please visit:https://www.markertherapeutics.com/email-alerts/

Forward-Looking Statement DisclaimerThis release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company's expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are "forward-looking statements." Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our research, development and regulatory activities and expectations relating to our non-engineered multi-tumor antigen specific T cell therapies; our TPIV200 and TPIV100/110 programs; the effectiveness of these programs or the possible range of application and potential curative effects and safety in the treatment of diseases; and, the timing and success of our clinical trials, as well as clinical trials conducted by our collaborators. Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stated in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the Company's most recent Form 10-K, 10-Q and other SEC filings which are available through EDGAR at http://www.sec.gov. The Company assumes no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Marker Therapeutics, Inc.

Condensed Consolidated Balance Sheets

(Unaudited)

September 30,

December 31,

2019

2018

ASSETS

Current assets:

Cash and cash equivalents

$ 48,477,670

$ 61,746,748

Prepaid expenses and deposits

1,906,062

141,717

Interest receivable

78,145

108,177

Total current assets

50,461,877

61,996,642

Non-current assets:

Property, plant and equipment, net

438,881

147,668

Right-of-use assets, net

501,714

-

Total non-current assets

940,595

147,668

Total assets

$ 51,402,472

$ 62,144,310

LIABILITIES AND STOCKHOLDERS' EQUITY

Current liabilities:

Accounts payable and accrued liabilities

$ 2,858,808

$ 2,754,572

Lease liability

199,266

-

Warrant liability

129,000

49,000

Total current liabilities

3,187,074

2,803,572

Non-current liabilities:

Lease liability, net of current portion

333,480

-

Total non-current liabilities

333,480

-

Total liabilities

3,520,554

2,803,572

Commitments and contingencies

-

-

Stockholders' equity:

Preferred stock - $0.001 par value, 5 million shares authorized and 0 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively

-

-

Common stock, $0.001 par value, 150 million shares authorized, 45.7 million and 45.4 million shares issued and outstanding as of September 30, 2019 and December 31, 2018, respectively

45,723

45,440

Additional paid-in capital

370,290,447

365,400,748

Accumulated deficit

(322,454,252)

(306,105,450)

Total stockholders' equity

47,881,918

See the article here:
Marker Therapeutics Reports Third Quarter 2019 Operating and Financial Results - P&T Community

Xing-Hua Xiao,* Qi-Yuan Huang,* Xian-Ling Qian,* Jing Duan, Xue-Qiao Jiao, Long-Yuan Wu, Qing-Yun Huang, Jun Li, Xing-Ning Lai, Yu-Bo Shi, Li-Xia Xiong

Department of Pathophysiology, Medical College, Nanchang University, Nanchang 330006, Peoples Republic of China

*These authors contributed equally to this work

Correspondence: Li-Xia XiongDepartment of Pathophysiology, Medical College, Nanchang University, 461 Bayi Road, Nanchang 330006, Peoples Republic of ChinaTel +86-791-8636-0556Email xionglixia@ncu.edu.cn

Purpose: Type 1 diabetes mellitus (T1DM) is characterized by irreversible islet cell destruction. Accumulative evidence indicated that Cdc42 and Wnt/-catenin signaling both play a critical role in the pathogenesis and development of T1DM. Further, bio-molecular mechanisms in adipose-derived mesenchymal stem cells (ADSCs)-derived insulin-producing cells (IPCs) remain largely unknown. Our aim was to investigate the underlying mechanism of Cdc42/Wnt/-catenin pathway in ADSC-derived IPCs, which may provide new insights into the therapeutic strategy for T1DM patients.Methods: ADSC induction was accomplished with DMSO under high-glucose condition. ML141 (Cdc42 inhibitor) and Wnt-3a (Wnt signaling activator) were administered to ADSCs from day 2 until the induction finished. Morphological changes were determined by an inverted microscope. Dithizone staining was employed to evaluate the induction of ADSC-derived IPCs. qPCR and Western blotting were employed to measure the mRNA and protein expression level of islet cell development-related genes and Wnt signaling-related genes. The proliferation ability of ADSC-derived IPCs was also detected with a cell counting kit (CCK) assay. The expression and secretion of Insulin were detected with immunofluorescence test and enzyme-linked immunosorbent assay (ELISA) respectively.Results: During induction, morphological characters of ADSCs changed into spindle and round shape, and formed islet-line cell clusters, with brown dithizonestained cytoplasm. Expression levels of islet cell development-related genes were up-regulated in ADSC-derived IPCs. Wnt-3a promoted Wnt signaling markers and islet cell development-related gene expression at mRNA and protein levels, while ML141 played a negative effect. Wnt-3a promoted ADSC-derived IPC proliferation and glucose-stimulated insulin secretion (GSIS), while ML141 played a negative effect.Conclusion: Our research demonstrated that DMSO and high-glucose condition can induce ADSCs into IPCs, and Wnt signaling promotes the induction. Cdc42 may promote IPC induction, IPC proliferation and insulin secretion via Wnt/-catenin pathway, meaning that Cdc42 may be regarded as a potential target in the treatment of T1DM.

Keywords: Cdc42, ML141, ADSCs, IPCs, Wnt signaling, insulin

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

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Cdc42 Promotes ADSC-Derived IPC Induction, Proliferation, And Insulin | DMSO - Dove Medical Press

VANCOUVER, Washington, Nov. 12, 2019 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today it has received approval from the Institutional Review Board (IRB) for leronlimab to be administered to patients with triple-negative breast cancer (TNBC) under a compassionate use, which is also known as expanded access program.

This program will allow TNBC patients who are not eligible under the ongoing Phase 1b/2 clinical trial to receive leronlimab (PRO 140). Under this protocol, patients with locally recurrent or metastatic triple-negative breast cancer who had progressed within six months or less on latest chemotherapy will receive leronlimab (PRO 140) combined with a treatment of physicians choice.

The compassionate use or expanded access program is a potential pathway for patients with an immediately life-threatening condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. An IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects pursuant to regulations of the U.S. Food and Drug Administration (FDA).

We are very pleased with the confidence demonstrated by the IRB to allow access to leronlimab for patients with triple-negative breast cancer. We are dedicated to advancing this therapeutic opportunity to many more patients in our ongoing trials, stated Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn.

Expanded access may be appropriate when all the following apply:

Investigational drugs, biologics or medical devices have not yet been approved or cleared by FDA and FDA has not found these products to be safe and effective for their specific use. Furthermore, the investigational medical product may, or may not, be effective in the treatment of the condition, and use of the product may cause unexpected serious side effects.

About Leronlimab (PRO 140)The U.S. Food and Drug Administration (FDA) has granted a "Fast Track" designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with highly active anti-retroviral therapy (HAART) for HIV-infected patients, and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including non-alcoholic steatohepatitis (NASH). Leronlimab has successfully completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab can significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 plays a vital role in tumor invasion and metastasis. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019. CytoDyn is conducting additional research with leronlimab in the setting of oncology and NASH with plans to conduct further clinical studies when appropriate.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be important in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD. Blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted "orphan drug" designation to leronlimab for the prevention of GvHD.

About CytoDynCytoDyn is a biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a crucial role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH. CytoDyn has completed a Phase 3 pivotal trial with leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients. CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in 2019 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication, which, if successful, could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, results from a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients. Some patients on leronlimab monotherapy have viral suppression for more than four years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and has received clearance to initiate a clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at http://www.cytodyn.com.

Forward-Looking StatementsThis press release contains certain forward-looking statements that involve risks, uncertainties, and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as "believes," "hopes," "intends," "estimates," "expects," "projects," "plans," "anticipates" and variations thereof, or the use of future tense, identify forward-looking statements but, their absence does not mean that a statement is not forward-looking. The Company's forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i)the sufficiency of the Companys cash position, (ii)the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv)the Companys ability to enter into partnership or licensing arrangements with third parties, (v)the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi)the Companys ability to achieve approval of a marketable product, (vii)the design, implementation and conduct of the Companys clinical trials, (viii)the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix)the market for, and marketability of, any product that is approved, (x)the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi)regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii)general economic and business conditions, (xiii)changes in foreign, political, and social conditions, and (xiv)various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form10-K, and any risk factors or cautionary statements included in any subsequent Form10-Q or Form8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CONTACTSInvestors: Nader Pourhassan, Ph.D.President & CEOnpourhassan@cytodyn.com

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CytoDyn Receives IRB Approval To Proceed With Compassionate Use Of Leronlimab For Patients With Triple-Negative Breast Cancer - GlobeNewswire

What is flow cytometry and how does it work?Flow cytometry(FCM) is a scientific technique used to measure the physical and biochemical characteristics of cells.1The sample is injected into the flow cytometer instrument, where it is typically focused to flow one cell at a time past light sources and detectors. Tens of thousands of cells can be examined in seconds to determine their morphology, granularity, scattering and transmission of light, or fluorescence of biomarkers, depending on the variation of FCM used.

The first conventional fluorescence-based flow cytometer was developed and commercialized in the late 60s/early 70s in Germany.2 Over the last five decades, FCM has developed rapidly in terms of the number of its applications and the quantity and dimensionality of the data it generates.1,3 Dr. Minh Doan, formerly of the Imaging Platform of the Broad Institute (USA) and now head of Bioimaging Analytics at GlaxoSmithKline in the USA, states, There have been significant advances in all three Vs of flow cytometry data: velocity (throughput/speed of data acquisition), volume (data content), and variety (sample types and signal acquisition technology).

Michael Parsons, manager of the Flow Cytometry Core of the Lunenfeld-Tanenbaum Research Institute in Toronto, Canada, agrees. The two biggest trends in flow cytometry are high content data and the merging of technologies from separate disciplines. For example, the last five years or so have seen the emergence of mass cytometry, which merges the disciplines of flow cytometry and mass spectrometry. In its latest iteration, an image cytometry module has been incorporated to generate unprecedented amounts of content (number of measured parameters) from relatively small amounts of patient tissue. Spectral flow cytometry has also established itself as an important emerging technology. Indeed, mass cytometry can now measure up to 50 features on a single cell simultaneously using antibodies tagged with rare earth metals,4 and imaging flow cytometry allows for 1000s of morphological features and multiple fluorescence markers to be analyzed per cell.3Flow cytometry, therefore, has inarguable potential as a clinical tool for disease diagnosis, prognosis, and therapeutic monitoring. However, some challenges remain in translating the full promise of FCM into clinical practice. Here, some of the current clinical applications of FCM will be discussed, as well as some of the compelling new applications being researched.

Similarly, FCM of liquid biopsies could be used to detect circulating tumor cells in the bloodstream.3 These cells are extremely rare, and with its high sensitivity, FCM is perfectly poised to make a significant impact in this area. This approach has potential for the clinical detection of early-stage cancer as well as the detection of circulating metastatic or drug-resistant cancer cells. For example, a study published earlier this year described label-free liquid biopsy with very high throughput (> 1 million cells/second) for drug-susceptibility testing during leukemia treatment.8

Prior to an organ transplant, FCM can be used to crossmatch the patient's serum with donor lymphocytes to detect antibodies that could result in organ rejection.1 Postoperatively, the analysis of various cell markers on the peripheral blood lymphocytes can indicate early transplant rejection, detect bone marrow toxicity arising from immunosuppressive therapies, and help differentiate infections from organ rejection. For blood transfusions, FCM can be used to detect contamination of blood with residual white blood cells, which can have adverse effects such as pulmonary edema.9Groups such as Dr. Roshini Abrahams at Nationwide Childrens Hospital in Ohio, USA, are using FCM to diagnose primary immunodeficiency disorders with the use of immunophenotyping and functional assays.10 These disorders are caused by genetic mutations that result in defects in the immune system, such as X-linked (Brutons) agammaglobulinemia and X-linked hyper-IgM syndrome. Over 300 of these disorders have been identified thus far, and the causative mutations lower immune defense against the attack of infections.

HIV is, of course, an example of a secondary (acquired) immunodeficiency disorder. FCM analysis of CD4 and other markers on lymphocytes in the peripheral blood is used to monitor the treatment of HIV patients, and a CD4 count <200 cells/mL together with a positive antibody test for HIV is used as a diagnostic for AIDS.1 Secondary immunodeficiencies can also be caused by e.g., substance abuse, malnutrition, other medical conditions, and certain medical treatments. FCM of a panel of markers can be used to confirm suspected cases.1In pregnancy, when a Rhesus blood group D-negative mother carries a D-positive fetus, fetal-maternal bleeding can sensitize the mother to the D-positive blood cells from the fetus and this can be fatal to subsequent D-positive newborns.11 FCM is used to measure the degree of fetal-maternal hemorrhage to determine the correct dose of prophylactics to be administered shortly after delivery.

In addition to oncology and immunology applications, FCM is also used to diagnose a variety of rare hematologic disorders12 as well as autoimmune/autoinflammatory disorders such as spondylarthritis (arthritis of the spine).13 Another area of research that is likely to give rise to increasing clinical applications in the future is that of platelet activity, which is important in many clinical conditions.1,14

Experts suggest that it may be possible to overcome this data analysis hurdle by applying machine learning approaches coupled with further standardization of FCM workflows.3,15 The most exciting applications of high content data revolve around the use of machine learning, in particular, deep learning, to extract relevant meaning from large data sets. Machine learning, coupled with big data, has the potential for driving diagnosis and treatment options tailored to the patients disease in a timely manner, says Dr. Parsons. In addition, Prof. Sadao Ota of RCAST at the University of Tokyo, Japan, points out, We still need to figure out how to design a workflow that convincingly validates diagnostic results, especially if the diagnosis employs the power of machine learning. Such developments are necessary before the rich information content of advanced FCM technology can be fully applied in the clinic.

In terms of other future advances in the field, Prof. Ota specifically makes mention of the potential of cell sorters combined with FCM.16 There are exciting and unique applications of sorters in fields such as cell therapy and regenerative medicine. Also, creating key applications of imaging cell sorters in pharmaceutical fields may accelerate global drug discovery. Dr. Doan concurs, Disease heterogeneity makes it hard to validate findings. Perhaps the use of flow cytometry with sorting capability can help such validation, where events-of-interest collected by flow cytometry can be validated with other downstream assays. Finally, as Dr. Doan notes, With multiple layers of data(types) incorporated altogether, there are now possibilities to do more with less, i.e., label-free sample measurement, which could lead to more direct, faster, and smarter diagnoses. Rare events (e.g., metastatic cancer cells) may soon be detected better than before.References1.Bakke A.C. Clinical Applications of Flow Cytometry. Laboratory Medicine. 2000; 31(2): 97104. doi: 10.1309/FC96-DDY4-2CRA-71FK.2.Herzenberg L.A., Parks D., Sahaf B., Perez O., Roederer M., Herzenberg L.A. The history and future of the fluorescence activated cell sorter and flow cytometry: a view from Stanford. Clinical Chemistry. 2002;48(10):181918273.Doan M., Vorobjev I., Rees P., Filby A., Wolkenhauer O., Goldfeld A.E., Lieberman J., Barteneva N., Carpenter A.E., Hennig H. Diagnostic potential of imaging flow cytometry. Trends in Biotechnology. 2018;36(7):649652. doi: 10.1016/j.tibtech.2017.12.008.4.Olsen L.R, Leipold M.D., Pedersen C.B., Maecker H.T. The anatomy of single cell mass cytometry data. Cytometry Part A. 2019;95(2):156172. doi: 10.1002/cyto.a.23621.5.Laerum O.D., Farsund T. Clinical application of flow cytometry: a review. Cytometry. 1981;2(1):113. doi: 10.1002/cyto.990020102.6.Li J., Wertheim G., Paessler M., Pillai V. Flow cytometry in pediatric hematopoietic malignancies. Clinics in Laboratory Medicine. 2017;37(4):879893. doi: 10.1016/j.cll.2017.07.009.7.Gupta S., Devidas M., Loh M.L., Raetz E.A., Chen S., Wang C., Brown P., Carroll A.J., Heerema N.A., Gastier-Foster J.M., Dunsmore K.P., Larsen E.C., Maloney K.W., Mattano L.A. Jr., Winter S.S., Winick N.J., Carroll W.L., Hunger S.P., Borowitz M.J., Wood B.L. Flow-cytometric vs. -morphologic assessment of remission in childhood acute lymphoblastic leukemia: a report from the Childrens Oncology Group (COG). Leukemia. 2018;32(6):13701379. doi: 10.1038/s41375-018-0039-7.8.Kobayashi H., Lei C., Wu Y., Huang C-J., Yasumoto A., Jona M., Li W., Wu Y., Yalikun Y., Jiang Y., Guo B., Sun C-W., Tanaka Y., Yamada M., Yatomi Y., Goda K. Intelligent whole-blood imaging flow cytometry for simple, rapid, and cost-effective drug-susceptibility testing of leukemia. Lab on a Chip. 2019;19(16):26882698. doi: 10.1039/c8lc01370e.9.Castegnaro S., Dragone P., Chieregato K., Alghisi A., Rodeghiero F., Astori G. Enumeration of residual white blood cells in leukoreduced blood products: Comparing flow cytometry with a portable microscopic cell counter. Transfusion and Apheresis Science. 2016;54(2):266270. doi: 10.1016/j.transci.2015.10.001.10.Abraham R.S., Aubert G. Flow cytometry, a versatile tool for diagnosis and monitoring of primary immunodeficiencies. Clinical and Vaccine Immunology. 2016;23(4):254271. doi: 10.1128/CVI.00001-16.11.Kim Y.A., Makar R.S. Detection of fetomaternal hemorrhage. American Journal of Hematology. 2012;87(4):417423. doi: 10.1002/ajh.22255.12.Bn M.C., Le Bris Y., Robillard N., Wuillme S., Fouassier M., Eveillard M. Flow cytometry in hematological nonmalignant disorders. International Journal of Laboratory Hematology. 2016;38(1):516. doi: 10.1111/ijlh.12438.13.Duan Z., Gui Y., Li C., Lin J., Gober H.J., Qin J., Li D., Wang L. The immune dysfunction in ankylosing spondylitis patients. Bioscience Trends. 2017;11(1):6976. doi: 10.5582/bst.2016.01171.14.Pasalic L. Assessment of platelet function in whole blood by flow cytometry. Methods in Molecular Biology. 2017;1646:349367. doi: 10.1007/978-1-4939-7196-1_27.15.Doan M., Carpenter A.E. Leveraging machine vision in cell-based diagnostics to do more with less. Nature Materials. 2019;18(5):414418. doi: 10.1038/s41563-019-0339-y.16.Ota S., Horisaki R., Kawamura Y., Ugawa M., Sato I., Hashimoto K., Kamesawa R., Setoyama K., Yamaguchi S., Fujiu K., Waki K., Noji H. Ghost cytometry. Science. 2018;360(6394):12461251. doi: 10.1126/science.aan0096.

Excerpt from:
The Value and Versatility of Clinical Flow Cytometry - Technology Networks

VANCOUVER, Washington, Nov. 11, 2019 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today encouraging initial results from the first patient in a Phase 1b/2 clinical trial with metastatic triple-negative breast cancer (mTNBC). Circulating tumor cells (CTC) in the patients blood decreased significantly after leronlimab therapy at both two-week and five-week time points. Furthermore, a reduction in CCR5 expression on presumed metastatic tumor cells was evident.

We are excited to be involved with CytoDyn in evaluating the efficacy of leronlimab in mTNBC," stated IncellDx CEO, Bruce Patterson, M.D. These results at both two-week and five-week time intervals post-leronlimab therapy indicate initial efficacy against this most aggressive tumor type. Moreover, the reduction of CCR5 expression on EMT cells may prove to be significant, as high CCR5 expression is believed to be crucial for metastases.

The treatment of mTNBC with leronlimab in this Phase 1b/2 trial is in addition to metastatic breast cancer (MBC) patients treated with leronlimab under an emergency use IND. Results from both of the ongoing trials in MBC will dictate the Companys regulatory pathway, including the potential to seek Breakthrough Therapy designation and accelerated approval with the U.S. FDA for the use of leronlimab in MBC. Leronlimab has been granted Fast Track designation for mTNBC by the FDA based on a greater than 98% reduction of metastatic tumor volume in a murine xenograft model.

Today marks yet another significant milestone in our Companys history, advancing CytoDyns clinical development in oncology. Although these are early results in our first patient, we are encouraged by the reduction in both CTC and tumor size. Our safety record with leronlimab, and preclinical results in multiple oncology trials in various cancer indications, solidifies our vision to explore oncology indications. We are optimistic about the opportunity to provide a potential new therapeutic option for the women that are diagnosed with invasive breast cancer each year in the United States. We wish to thank the women who have agreed to participate in our trials and will endeavor to provide each of them with clinical benefit," stated CytoDyn President and CEO, Nader Pourhassan, Ph.D.

About Leronlimab (PRO 140)The U.S. Food and Drug Administration (FDA) has granted a "Fast Track" designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with highly active antiretroviral therapy (HAART) for HIV-infected patients, and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including non-alcoholic steatohepatitis (NASH). Leronlimab has successfully completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab can significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 plays a vital role in tumor invasion and metastasis. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019. CytoDyn is conducting additional research with leronlimab in the setting of oncology and NASH with plans to conduct further clinical studies when appropriate.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be important in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD. Blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted "orphan drug" designation to leronlimab for the prevention of GvHD.

About CytoDynCytoDyn is a biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a crucial role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH. CytoDyn has completed a Phase 3 pivotal trial with leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients. CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in 2019 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication, which, if successful, could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs).Moreover, results from a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients. Some patients on leronlimab monotherapy have viral suppression for more than four years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and has received clearance to initiate a clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at http://www.cytodyn.com.

Forward-Looking StatementsThis press release contains certain forward-looking statements that involve risks, uncertainties, and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as "believes," "hopes," "intends," "estimates," "expects," "projects," "plans," "anticipates" and variations thereof, or the use of future tense, identify forward-looking statements but, their absence does not mean that a statement is not forward-looking. The Company's forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i)the sufficiency of the Companys cash position, (ii)the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv)the Companys ability to enter into partnership or licensing arrangements with third parties, (v)the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi)the Companys ability to achieve approval of a marketable product, (vii)the design, implementation and conduct of the Companys clinical trials, (viii)the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix)the market for, and marketability of, any product that is approved, (x)the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi)regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii)general economic and business conditions, (xiii)changes in foreign, political, and social conditions, and (xiv)various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form10-K, and any risk factors or cautionary statements included in any subsequent Form10-Q or Form8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CONTACTSInvestors: Nader Pourhassan, Ph.D.President & CEOnpourhassan@cytodyn.com

Link:
First Patient in CytoDyn's Triple-Negative Metastatic Breast Cancer Trial Shows Significant Reduction in Circulating Tumor Cells (CTC) and Reduced...