Cocrystal Pharma Announces the Passing of Chairman, CEO and Co-founder Dr. Gary Wilcox

 

BOTHELL, Wash., May 28, 2021 (GLOBE NEWSWIRE) — With great sadness, Cocrystal Pharma, Inc. (Nasdaq: COCP), (“Cocrystal” or the “Company”) announces that Gary Wilcox, Ph.D., Chairman, CEO and co-founder, suddenly passed away Wednesday, May 26 at the age of 74. The Board of Directors and staff of Cocrystal extend their deepest condolences to the Wilcox family and express their gratitude for Gary’s contributions to Cocrystal and to human health.

The Cocrystal Board of Directors has designated Sam Lee, Ph.D., President, and James Martin, CFO, to share the CEO responsibilities while seeking a successor for the position. Roger Kornberg, Ph.D., Cocrystal co-founder, Chief Scientist, Director and Chairman of the Scientific Advisory Board, has been named Chairman of the Board, and Steve Rubin, Director of Cocrystal and its predecessor company since 2008, has been named Vice Chairman. Cocrystal also announces the appointment of Richard C. Pfenniger, Jr. to the Board of Directors, maintaining membership at five. Mr. Pfenniger brings significant industry knowledge and corporate governance expertise, having served as chief executive officer, chief operating officer, general counsel, director and chairman at multiple healthcare companies.

“We are fortunate to have two highly qualified and dedicated executives in Sam and Jim to assume the CEO duties on an interim basis. Our Board has full confidence in a smooth transition and in their ability to advance our antiviral programs into clinical development,” said Dr. Kornberg. “We also welcome Richard to our Board. We will call upon his insights regarding many aspects of our business and to provide valuable operational, leadership and management advice to the Board in critical areas.

“The Cocrystal team is committed to carrying on Gary’s quest to address the growing global need for new antiviral treatments,” added Dr. Kornberg. “We will deeply miss Gary. He possessed a rare combination of scientific brilliance, business acumen and personal humility. He was an accomplished leader and earned respect throughout the biotechnology community, having achieved more in his 35 years in the industry than I can list. He brought an entrepreneurial spirit to Cocrystal that has been instrumental in deploying our novel replication technology to advance the discovery and development of antiviral candidates, and he sustained that spirit each and every day.”

Richard Pfenniger, Jr.

Mr. Pfenniger is a private investor who served as Interim CEO of Vein Clinics of America, Inc., a privately held company that specializes in the treatment of vein disease, from May 2014 to February 2015 and as Interim CEO of IntegraMed America, Inc., a privately held company that manages outpatient fertility medical centers, from January 2013 to June 2013. He served as Chief Executive Officer and President of Continucare Corporation, a provider of primary care physician and practice management services, from 2003 until 2011, and as Chairman of the Board of Directors of Continucare Corporation from 2002 until 2011. Previously, Mr. Pfenniger served as the Chief Executive Officer and Vice Chairman of Whitman Education Group, Inc. from 1997 through June 2003. Prior to joining Whitman, he served as the Chief Operating Officer of IVAX from 1994 to 1997, and, from 1989 to 1994, he served as the Senior Vice President-Legal Affairs and General Counsel of IVAX Corporation. Prior thereto he was engaged in the private practice of law.

Mr. Pfenniger currently serves as a director of OPKO Health (Nasdaq: OPK), a multinational biopharmaceutical and diagnostics company, GP Strategies Corporation (NYSE: GPX), a corporate education and training company, and Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company. He also serves as the Vice Chairman of the Board of Trustees and as a member of the Executive Committee of the Phillip and Patricia Frost Museum of Science in Miami.

About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of coronaviruses (including SARS-CoV-2), influenza viruses, hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100
jcain@lhai.com

Source: Cocrystal Pharma, Inc.

Noble Capital Markets Senior Research Analyst Joe Gomes sits down with Avivagen CEO Kym Anthony for this exclusive interview. Research, News, and Advanced Market Data on VIVXF View all C-Suite Interviews About Avivagen Avivagen is a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that, by safely supporting immune function, promote general health and performance. It is a public corporation traded on the TSX Venture Exchange under the symbol VIV and is headquartered in Ottawa, Canada, based in partnership facilities of the National Research Council of Canada. For more information, visit www.avivagen.com.

FWC Fish and Wildlife Research (Flickr)

Studying Many Genes in Many Animals is Key to Understanding How Humans Can Live Longer

 

Much of longevity and aging research focuses on studying extremely long-lived species, including bats, naked mole-rats and bowhead whales, to find genetic changes that contribute to long life.

However, such work has yielded highly species-specific genetic changes that are not generalizable to other species, including humans. As a graduate student, I have studied growing evidence, including recent work from my advisers’ labs, that supports the hypothesis that lifespan is a complex and highly context-dependent trait that calls for a shift in how biologists think about aging.

 

Old Age: The Human Problem

Aging is the process by which the likelihood of death increases the longer an organism is alive. In mammals, aging is hallmarked by several molecular changes, including the breakdown of DNA, a shortage of stem cells and malfunctioning proteins.

Numerous theories that exist to explain why aging happens fall into two categories. “Wear-and-tear” theories postulate that essential processes simply wear out over time. On the other hand, “programmed death” theories assert that specific genes or processes are designed to drive aging.

Traditional definitions and aging theories are human-centric, and when we examine aging from a cross-species perspective, it becomes clear that human aging is unique. In fact, among animals there is no typical way to age.

Humans show low mortality rates until a sharp spike in mortality at very old age, around 80 years. Most mammals have relatively less increase in mortality with age and more consistent mortality through their lifespans. Some mammals, such as the tundra vole and the yellow-bellied marmot, show virtually no increase in mortality with age. In other words, older individuals are equally as likely to die as younger individuals, possibly because aging does not impact survival.

Current aging theories fail to explain the full complexity of aging across all mammals, let alone the tree of life. Such diversity not only highlights the complexity of aging and longevity but also makes it difficult to apply knowledge gained about one species to increase lifespan in another.

 

 

 

 

An Overabundance of ‘Longevity Genes’

Studies of exceptionally long-lived species have produced a plethora of so-called longevity genes. One such gene, called the insulin-like growth factor 1, or IGF1, receptor gene, promotes cell growth. IGF1 was originally associated with long life in bats and also increases lifespan in worms and mice. However, IGF1 may have the opposite effect in humans, because too much IGF1 may increase age-related illnesses like diabetes and cancer.

Another potential longevity gene called the ERCC1 gene produces a protein that helps repair DNA. The bowhead whale, the longest-lived mammal at 211 years, has a mutation in the ERCC1 gene that may contribute to the species’ exceptionally long lifespan, but the mutation is not shared by other long-lived species. Elephants have 19 copies of the TP53 gene, an essential cancer prevention gene, but adding even one extra TP53 gene to mice accelerates aging because stem cells are slower to regenerate.

Longevity genes can be inconsistent even within a single species. Studies that hunt for genetic changes common in long-lived humans, and absent from humans who lived shorter lives, have not delivered a master longevity gene. The genes detected are largely inconsistent across studies and rely heavily on the subpopulation of humans sampled and the precise definition of “exceptionally long-lived.”

 

How do we
Find Longevity Genes?

My recent work underscores the argument that aging-researchers should not be looking for individual longevity genes. Instead, biologists should be seeking many genes with similar functions working together to control longevity. Further, an effective search should not just focus on a single species, but many, to avoid species-specific elements.

As part of a research study, I used genomes from 61 mammals to detect genes that evolved in tandem with the evolution of extreme lifespan, thereby uncovering longevity-related changes universal across all mammals. At the gene level, I found few longevity genes, which makes sense in light of previous work. There is probably no single gene in all mammals that regulates lifespan.

 

 

When I looked at the big picture, however, and considered groups of genes working together to perform a similar function, I found a strong association between longevity and pathways related to controlling cancer. Examples of such groups of genes are those involved in regulating the cell cycle and programmed cell death, and pathways for immune function and DNA repair. All of these functions have been previously implicated in lifespan regulation in a wide variety of studies.

 

A New Perspective on Aging and Longevity

Species-specific and human genome-wide association studies have limitations that may be enriched by a broader analyses, both in terms of the genomic elements studied and the species considered. Rather than searching for a single gene in a single species that drives increased lifespan, broadening the search to many genes across many species can bring new insights.

One modified genome-wide approach using information about functional relationships among genes found an association between the human IGF1 pathway and longevity scattered over nine genes, a key example of broadening the search for the genetics of lifespan beyond single genes.

Similarly, comparative studies like mine that interrogate genetic similarities and differences among long-lived species have repeatedly demonstrated the power to detect longevity-related genetic changes spread over many genes and shared across many species.

While there may not be a proverbial genetic “Fountain of Youth” – one single genetic change that magically allows us all to live longer – scientists like me are continually improving our strategies to study longevity so we can someday all have longer, healthier lives.

 

This article was republished with permission from The Conversation, a news site
dedicated to sharing ideas from academic experts.  Written by: Amanda Kowalczyk Ph.D.
Candidate in Computational and Systems Biology, University of Pittsburgh

 

Suggested Reading:

 

Learning to Speak the Language of Viruses	Cells that can be Produced From Stem Cells

Preventing the Immune System from Rejecting Gene Therapy	Healthcare Panel Discussion NobleCon (January 2021)

 

 

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Cocrystal Pharma Announces the Passing of Chairman, CEO and Co-founder Dr. Gary Wilcox

 

BOTHELL, Wash., May 28, 2021 (GLOBE NEWSWIRE) — With great sadness, Cocrystal Pharma, Inc. (Nasdaq: COCP), (“Cocrystal” or the “Company”) announces that Gary Wilcox, Ph.D., Chairman, CEO and co-founder, suddenly passed away Wednesday, May 26 at the age of 74. The Board of Directors and staff of Cocrystal extend their deepest condolences to the Wilcox family and express their gratitude for Gary’s contributions to Cocrystal and to human health.

The Cocrystal Board of Directors has designated Sam Lee, Ph.D., President, and James Martin, CFO, to share the CEO responsibilities while seeking a successor for the position. Roger Kornberg, Ph.D., Cocrystal co-founder, Chief Scientist, Director and Chairman of the Scientific Advisory Board, has been named Chairman of the Board, and Steve Rubin, Director of Cocrystal and its predecessor company since 2008, has been named Vice Chairman. Cocrystal also announces the appointment of Richard C. Pfenniger, Jr. to the Board of Directors, maintaining membership at five. Mr. Pfenniger brings significant industry knowledge and corporate governance expertise, having served as chief executive officer, chief operating officer, general counsel, director and chairman at multiple healthcare companies.

“We are fortunate to have two highly qualified and dedicated executives in Sam and Jim to assume the CEO duties on an interim basis. Our Board has full confidence in a smooth transition and in their ability to advance our antiviral programs into clinical development,” said Dr. Kornberg. “We also welcome Richard to our Board. We will call upon his insights regarding many aspects of our business and to provide valuable operational, leadership and management advice to the Board in critical areas.

“The Cocrystal team is committed to carrying on Gary’s quest to address the growing global need for new antiviral treatments,” added Dr. Kornberg. “We will deeply miss Gary. He possessed a rare combination of scientific brilliance, business acumen and personal humility. He was an accomplished leader and earned respect throughout the biotechnology community, having achieved more in his 35 years in the industry than I can list. He brought an entrepreneurial spirit to Cocrystal that has been instrumental in deploying our novel replication technology to advance the discovery and development of antiviral candidates, and he sustained that spirit each and every day.”

Richard Pfenniger, Jr.

Mr. Pfenniger is a private investor who served as Interim CEO of Vein Clinics of America, Inc., a privately held company that specializes in the treatment of vein disease, from May 2014 to February 2015 and as Interim CEO of IntegraMed America, Inc., a privately held company that manages outpatient fertility medical centers, from January 2013 to June 2013. He served as Chief Executive Officer and President of Continucare Corporation, a provider of primary care physician and practice management services, from 2003 until 2011, and as Chairman of the Board of Directors of Continucare Corporation from 2002 until 2011. Previously, Mr. Pfenniger served as the Chief Executive Officer and Vice Chairman of Whitman Education Group, Inc. from 1997 through June 2003. Prior to joining Whitman, he served as the Chief Operating Officer of IVAX from 1994 to 1997, and, from 1989 to 1994, he served as the Senior Vice President-Legal Affairs and General Counsel of IVAX Corporation. Prior thereto he was engaged in the private practice of law.

Mr. Pfenniger currently serves as a director of OPKO Health (Nasdaq: OPK), a multinational biopharmaceutical and diagnostics company, GP Strategies Corporation (NYSE: GPX), a corporate education and training company, and Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company. He also serves as the Vice Chairman of the Board of Trustees and as a member of the Executive Committee of the Phillip and Patricia Frost Museum of Science in Miami.

About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of coronaviruses (including SARS-CoV-2), influenza viruses, hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100
jcain@lhai.com

Source: Cocrystal Pharma, Inc.

Ocugen On Track to Submit Emergency Use Authorization Application to U.S. FDA for its COVID-19 Vaccine Candidate, COVAXIN™

 

• Active discussions with FDA related to COVAXIN initiated late last year
  
• Master file submitted to FDA on March 26, 2021; awaiting feedback from FDA
  

MALVERN, Pa., May 26, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (Nasdaq: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today confirmed its plan to submit its Emergency Use Authorization (EUA) application for COVAXIN to the U.S. Food & Drug Administration (FDA) in June.

“Since we have been in discussions with the FDA since late last year, we do not believe that the FDA’s recently revised guidance regarding EUAs raises any concerns about our ability to submit the EUA for COVAXIN as planned, which is currently in process and which we expect to submit to the FDA in June. We believe that the FDA’s new guidance confirms that Ocugen continues to meet all criteria for submission of an EUA. Once the EUA application has been submitted, Ocugen intends to commence pre-biologics license application (BLA) discussions with the FDA,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-founder of Ocugen.

“FDA’s guidance refers specifically to vaccines based on the spike protein. COVAXIN is a unique yet traditional vaccine using an inactivated version of the whole virus with a novel adjuvant that provides a broadly protective immune response beyond the spike protein, offering potential effectiveness against multiple existing and emerging variants and reducing the possibility of mutant virus escape,” said Dr. Bruce Forrest, Acting Chief Medical Officer and member of the vaccine scientific advisory board of Ocugen.

About COVAXIN

COVAXIN, India’s COVID-19 vaccine by Bharat Biotech, is developed in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform with an excellent safety track record of more than 300 million doses supplied. Based on a traditional vaccine platform that has a long-established safety profile, COVAXIN continues to show strong results in all the studies conducted to date including a vaccine efficacy rate of 78% overall efficacy and 100% in severe COVID-19 disease, including hospitalizations, in second interim results of Bharat Biotech’s Phase 3 clinical trial.

In addition to generating strong immune response against multiple antigens, COVAXIN has been shown to generate memory T cell responses, for its multiple epitopes, indicating longevity and a rapid antibody response to future infections. With published data demonstrating a safety profile superior to published safety data from separate studies for several other vaccines, COVAXIN is packaged in multi-dose vials that can be stored at 2-8^?C.

COVAXIN studies show potential effectiveness against three key variants of SARS-CoV-2. Scientists at the Indian Council of Medical Research (ICMR)-National Institute of Virology, using an in-vitro plaque reduction neutralization assay, have found that COVAXIN-vaccinated sera effectively neutralized the Brazil variant of SARS-CoV-2, B.1.128.2, the UK variant, B.1.1.7, as well as the Indian double mutant variant, B.1.617. These studies suggest that COVAXIN vaccination may be effective against multiple SARS-CoV-2 variants.

About Ocugen, Inc.

Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN™ vaccine candidate for COVID-19 in the U.S. market. For more information, please visit www.ocugen.com.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements include information about qualitative assessments of available data, potential benefits, expectations for clinical trials, and anticipated timing of clinical trial readouts and regulatory submissions. This information involves risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preliminary and interim data (including the Phase 3 interim data referred to in this press release), including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when data from Bharat Biotech’s clinical trials will be published in scientific journal publications and, if so, when and with what modifications; whether the U.S. Food and Drug Administration (FDA) will be satisfied with the design of and results from preclinical and clinical studies of COVAXIN, which have been conducted by Bharat Biotech in India; whether and when any biologics license and/or emergency use authorization applications may be filed in the United States for COVAXIN; whether and when any such applications may be approved by the FDA; decisions by the FDA impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of COVAXIN in the United States, including development of products or therapies by other companies. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

Ocugen Contact:
Ocugen, Inc.
Sanjay Subramanian
CFO and Head of Corp. Dev.
IR@Ocugen.com

Media Contact:
LaVoieHealthScience
Lisa DeScenza
ldescenza@lavoiehealthscience.com
+1 9783955970 

Ocugen On Track to Submit Emergency Use Authorization Application to U.S. FDA for its COVID-19 Vaccine Candidate, COVAXIN™

 

• Active discussions with FDA related to COVAXIN initiated late last year
  
• Master file submitted to FDA on March 26, 2021; awaiting feedback from FDA
  

MALVERN, Pa., May 26, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (Nasdaq: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today confirmed its plan to submit its Emergency Use Authorization (EUA) application for COVAXIN to the U.S. Food & Drug Administration (FDA) in June.

“Since we have been in discussions with the FDA since late last year, we do not believe that the FDA’s recently revised guidance regarding EUAs raises any concerns about our ability to submit the EUA for COVAXIN as planned, which is currently in process and which we expect to submit to the FDA in June. We believe that the FDA’s new guidance confirms that Ocugen continues to meet all criteria for submission of an EUA. Once the EUA application has been submitted, Ocugen intends to commence pre-biologics license application (BLA) discussions with the FDA,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-founder of Ocugen.

“FDA’s guidance refers specifically to vaccines based on the spike protein. COVAXIN is a unique yet traditional vaccine using an inactivated version of the whole virus with a novel adjuvant that provides a broadly protective immune response beyond the spike protein, offering potential effectiveness against multiple existing and emerging variants and reducing the possibility of mutant virus escape,” said Dr. Bruce Forrest, Acting Chief Medical Officer and member of the vaccine scientific advisory board of Ocugen.

About COVAXIN

COVAXIN, India’s COVID-19 vaccine by Bharat Biotech, is developed in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform with an excellent safety track record of more than 300 million doses supplied. Based on a traditional vaccine platform that has a long-established safety profile, COVAXIN continues to show strong results in all the studies conducted to date including a vaccine efficacy rate of 78% overall efficacy and 100% in severe COVID-19 disease, including hospitalizations, in second interim results of Bharat Biotech’s Phase 3 clinical trial.

In addition to generating strong immune response against multiple antigens, COVAXIN has been shown to generate memory T cell responses, for its multiple epitopes, indicating longevity and a rapid antibody response to future infections. With published data demonstrating a safety profile superior to published safety data from separate studies for several other vaccines, COVAXIN is packaged in multi-dose vials that can be stored at 2-8^?C.

COVAXIN studies show potential effectiveness against three key variants of SARS-CoV-2. Scientists at the Indian Council of Medical Research (ICMR)-National Institute of Virology, using an in-vitro plaque reduction neutralization assay, have found that COVAXIN-vaccinated sera effectively neutralized the Brazil variant of SARS-CoV-2, B.1.128.2, the UK variant, B.1.1.7, as well as the Indian double mutant variant, B.1.617. These studies suggest that COVAXIN vaccination may be effective against multiple SARS-CoV-2 variants.

About Ocugen, Inc.

Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN™ vaccine candidate for COVID-19 in the U.S. market. For more information, please visit www.ocugen.com.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements include information about qualitative assessments of available data, potential benefits, expectations for clinical trials, and anticipated timing of clinical trial readouts and regulatory submissions. This information involves risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preliminary and interim data (including the Phase 3 interim data referred to in this press release), including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when data from Bharat Biotech’s clinical trials will be published in scientific journal publications and, if so, when and with what modifications; whether the U.S. Food and Drug Administration (FDA) will be satisfied with the design of and results from preclinical and clinical studies of COVAXIN, which have been conducted by Bharat Biotech in India; whether and when any biologics license and/or emergency use authorization applications may be filed in the United States for COVAXIN; whether and when any such applications may be approved by the FDA; decisions by the FDA impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of COVAXIN in the United States, including development of products or therapies by other companies. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

Ocugen Contact:
Ocugen, Inc.
Sanjay Subramanian
CFO and Head of Corp. Dev.
IR@Ocugen.com

Media Contact:
LaVoieHealthScience
Lisa DeScenza
ldescenza@lavoiehealthscience.com
+1 9783955970 

Thursday, May 27, 2021

Cocrystal Pharma Inc. (COCP)
Transferring Coverage and Reiterating Rating

Cocrystal Pharma Inc is a clinical stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication machinery of influenza viruses, hepatitis C viruses, and noroviruses. The company employs structure-based technologies and Nobel Prize-winning expertise to create first-and best-in-class antiviral drugs. It is developing CC-31244, an investigational, oral, broad-spectrum replication inhibitor called a non-nucleoside inhibitor (NNI). CC-31244 is currently being evaluated in a Phase 2a study for the treatment of hepatitis C as part of a cocktail for ultra-short therapy of 4 to 6 weeks.

Robert LeBoyer, Senior Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

A portfolio of anti-viral products with novel mechanisms of action.  The company has six antiviral products in development for Hepatitis C, Influenza, COVID-19, and Norovirus that are in development both as cocktails or monotherapies. We are transferring coverage and reiterating our rating on Cocrystal Pharmaceuticals. Our price target remains.


Proprietary technology.  Its technology is based on Noble-prize-winning discoveries by Dr. Roger Kornberg, Chief Scientist and Chairman of its Scientific Advisory Board. It product pipeline has been developed using its proprietary structure-based design, based on X-ray crystallogrpahy and protein engineering …

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary.  Proper due diligence is required before making any investment decision. 

Ceapro Inc. Announces Completion of Patient Enrollment in Clinical Study Evaluating Beta Glucan as a Cholesterol-Lowering Agent

 

– Clinical study evaluating the well-known health claims of beta glucan and its potentially beneficial approach for patients to lower plasma cholesterol –

– Study conducted in collaboration with the Montreal Heart Institute and led by MHI’s Montreal Health Innovations Coordinating Center (MHICC) –

– Topline data readout expected Q4 2021 –

EDMONTON, Alberta, May 26, 2021 (GLOBE NEWSWIRE) —  Ceapro Inc. (TSX-V: CZO) (“Ceapro” or the “Company”), a growth-stage biotechnology company focused on the development and commercialization of active ingredients for healthcare and cosmetic industries, today announced the completion of patient enrollment in its comparison study evaluating high-medium molecular weight beta glucan as a stand-alone or add-on therapy to statins (the “BetAvena study”) in subjects with hyperlipidemia.

The study is being conducted with the Montreal Heart Institute (MHI), led by Dr. Jean-Claude Tardif, Director of the Montreal Heart Institute Research Center and Principal Investigator for this clinical trial as part of a long-term collaboration.

“We are incredibly pleased with the flawless execution of this important clinical study, despite challenges posed by the COVID-19 pandemic. We are extremely grateful to Dr. Jean-Claude Tardif and his expert team at the Montreal Heart Institute and their dedication to getting this study across the finish line and providing the opportunity to assess and validate the well-known health benefits of beta glucan per the highest clinical practice standards. The amended protocol that we were granted for the study expanded our target addressable patient population, which provided both scientific and clinical value and aided in successfully completing patient enrollment. This is a major milestone for our Company as we expand as a biopharmaceutical company and we look forward to reporting topline data in the fourth quarter of this year,” stated Gilles Gagnon, M.Sc., MBA, President and CEO.

“With patient enrollment now complete, our team is focused on advancing this potential alternative treatment forward and bring the study to successful completion. Pending statistical review, the BetAvena study may represent a significant shift for the patient community hoping to achieve hyperlipidemia control with nutraceuticals such as Ceapro’s CP105F. We are impressed by the engagement of our clinical sites and our patients who had to compose with very difficult COVID circumstances,” added Dr. Tardif.

This multicenter, randomized, double-blind, parallel group, placebo-controlled study is conducted to determine the efficacy and safety of high-medium molecular weight beta glucan in subjects with hyperlipidemia (LDL-C level >130 mg/d L (3.37 mmol/L). The 18 to 24-month study enrolled approximately 264 subjects who cannot tolerate high doses of current treatments. The Company received approval from Health Canada in February 2020 to expand the inclusion criteria of the study to allow evaluation of enrolled subjects with confirmed pathophysiological condition of hyperlipidemia who voluntarily request to be treated with beta glucan only, without regular dosing of statins. Enrolled patients were randomized to receive either placebo, low, medium or high doses of beta glucan (500 mg tablet) as add-on therapy, or not, to atorvastatin 10 mg – 20 mg or an equivalent statin for a 12-week treatment period. The primary efficacy endpoint of the study is the change over 12 weeks in LDL-cholesterol.

The Company anticipates the statistical analysis to be completed this fall and subsequently submitted to Heath Canada. The Company expects to report topline data from the study in the fourth quarter of 2021.

About Ceapro Inc.

Ceapro Inc. is a Canadian biotechnology company involved in the development of proprietary extraction technology and the application of this technology to the production of extracts and “active ingredients” from oats and other renewable plant resources. Ceapro adds further value to its extracts by supporting their use in cosmeceutical, nutraceutical, and therapeutics products for humans and animals. The Company has a broad range of expertise in natural product chemistry, microbiology, biochemistry, immunology and process engineering. These skills merge in the fields of active ingredients, biopharmaceuticals and drug-delivery solutions. For more information on Ceapro, please visit the Company’s website at www.ceapro.com.

For more information contact:

Jenene Thomas
JTC Team, LLC
Investor Relations and Corporate Communications Advisor
T (US): +1 (833) 475-8247
E: czo@jtcir.com

Issuer:
Gilles R. Gagnon, M.Sc., MBA
President & CEO
T: 780-421-4555

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release

Source: Ceapro Inc.

Ceapro Inc. Announces Completion of Patient Enrollment in Clinical Study Evaluating Beta Glucan as a Cholesterol-Lowering Agent

 

– Clinical study evaluating the well-known health claims of beta glucan and its potentially beneficial approach for patients to lower plasma cholesterol –

– Study conducted in collaboration with the Montreal Heart Institute and led by MHI’s Montreal Health Innovations Coordinating Center (MHICC) –

– Topline data readout expected Q4 2021 –

EDMONTON, Alberta, May 26, 2021 (GLOBE NEWSWIRE) —  Ceapro Inc. (TSX-V: CZO) (“Ceapro” or the “Company”), a growth-stage biotechnology company focused on the development and commercialization of active ingredients for healthcare and cosmetic industries, today announced the completion of patient enrollment in its comparison study evaluating high-medium molecular weight beta glucan as a stand-alone or add-on therapy to statins (the “BetAvena study”) in subjects with hyperlipidemia.

The study is being conducted with the Montreal Heart Institute (MHI), led by Dr. Jean-Claude Tardif, Director of the Montreal Heart Institute Research Center and Principal Investigator for this clinical trial as part of a long-term collaboration.

“We are incredibly pleased with the flawless execution of this important clinical study, despite challenges posed by the COVID-19 pandemic. We are extremely grateful to Dr. Jean-Claude Tardif and his expert team at the Montreal Heart Institute and their dedication to getting this study across the finish line and providing the opportunity to assess and validate the well-known health benefits of beta glucan per the highest clinical practice standards. The amended protocol that we were granted for the study expanded our target addressable patient population, which provided both scientific and clinical value and aided in successfully completing patient enrollment. This is a major milestone for our Company as we expand as a biopharmaceutical company and we look forward to reporting topline data in the fourth quarter of this year,” stated Gilles Gagnon, M.Sc., MBA, President and CEO.

“With patient enrollment now complete, our team is focused on advancing this potential alternative treatment forward and bring the study to successful completion. Pending statistical review, the BetAvena study may represent a significant shift for the patient community hoping to achieve hyperlipidemia control with nutraceuticals such as Ceapro’s CP105F. We are impressed by the engagement of our clinical sites and our patients who had to compose with very difficult COVID circumstances,” added Dr. Tardif.

This multicenter, randomized, double-blind, parallel group, placebo-controlled study is conducted to determine the efficacy and safety of high-medium molecular weight beta glucan in subjects with hyperlipidemia (LDL-C level >130 mg/d L (3.37 mmol/L). The 18 to 24-month study enrolled approximately 264 subjects who cannot tolerate high doses of current treatments. The Company received approval from Health Canada in February 2020 to expand the inclusion criteria of the study to allow evaluation of enrolled subjects with confirmed pathophysiological condition of hyperlipidemia who voluntarily request to be treated with beta glucan only, without regular dosing of statins. Enrolled patients were randomized to receive either placebo, low, medium or high doses of beta glucan (500 mg tablet) as add-on therapy, or not, to atorvastatin 10 mg – 20 mg or an equivalent statin for a 12-week treatment period. The primary efficacy endpoint of the study is the change over 12 weeks in LDL-cholesterol.

The Company anticipates the statistical analysis to be completed this fall and subsequently submitted to Heath Canada. The Company expects to report topline data from the study in the fourth quarter of 2021.

About Ceapro Inc.

Ceapro Inc. is a Canadian biotechnology company involved in the development of proprietary extraction technology and the application of this technology to the production of extracts and “active ingredients” from oats and other renewable plant resources. Ceapro adds further value to its extracts by supporting their use in cosmeceutical, nutraceutical, and therapeutics products for humans and animals. The Company has a broad range of expertise in natural product chemistry, microbiology, biochemistry, immunology and process engineering. These skills merge in the fields of active ingredients, biopharmaceuticals and drug-delivery solutions. For more information on Ceapro, please visit the Company’s website at www.ceapro.com.

For more information contact:

Jenene Thomas
JTC Team, LLC
Investor Relations and Corporate Communications Advisor
T (US): +1 (833) 475-8247
E: czo@jtcir.com

Issuer:
Gilles R. Gagnon, M.Sc., MBA
President & CEO
T: 780-421-4555

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release

Source: Ceapro Inc.