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
[email protected]

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.

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
[email protected]

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.
[email protected]

Media Contact:
LaVoieHealthScience
Lisa DeScenza
[email protected]
+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. 

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.
[email protected]

Media Contact:
LaVoieHealthScience
Lisa DeScenza
[email protected]
+1 9783955970 

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: [email protected]

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: [email protected]

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.

image credit: This is Engineering, (Flickr)

Rare Metals Play a Strategic and Essential Role in Health

 

The COVID-19 pandemic has highlighted the fact that most countries do not have sufficient health sovereignty to face such a crisis. Shortages of masks, respirators, medicines and now vaccines were felt in many countries, even the most advanced. These problems show that our societies are dependent on certain countries for essential products.

But what about metals?

Our research team has been working for a few years on the interactions between earth sciences and social sciences, especially around the concept of social geology and the dynamics of resource-rich territories.

Strategic Metals

The notion of critical and strategic minerals goes back to the wars of the 19th century. At the end of the Second World War, the United States built up stocks of metals. However, the overabundance of metals at the end of the 20th century and globalization led western states to abandon their proactive policy in this field. Awareness of dependence on imported mineral resources did not return until the late 1990s, with the emergence of Asian economies and new monopolies.

The list of critical and strategic metals varies from country to country, ranging from a dozen for the French National Defense to the 35 metals listed in the decree of President Donald Trump in 2018.

Why do we have these lists of metals? They reflect the major issues of the past, those of the wars of the 20th century and the conflicts feared for the future. More generally, they mark the technological and social crises that have hit our societies during the past 50 years and which have led to what the German sociologist Ulrich Beck has called the risk society.

Each crisis has left in its wake new technological solutions, secure supply chains and an increased awareness of the dependence on various metals. Here are a few examples.

 

From Oil to Gold

In 1973, the oil crisis highlighted the energy fragility of most developed countries. Some countries turned to nuclear power, others to hydroelectricity. Uranium mines were put into production everywhere, from Saskatchewan to Niger. The price of ore soared in 1978 and production peaked in 1980.

The terrorist crisis of 2001 in turn accelerated the development of information technology in the defence industries and the consumption of high-tech metals increased accordingly. The price of tantalum reached its highest point in 2000 and world production peaked in 2004. This demand encouraged artisanal production in eastern Congo, which has been a centre of conflict for 20 years.

The nuclear crises following the 1986 Chernobyl and 2011 Fukushima accidents encouraged a shift to metal-intensive renewable energies, particularly wind power. The price of rare-earth elements exploded to a peak in 2010 and production doubled in the following decade.

Finally, in 2008, the financial crisis weakened global markets and led to a resumption of gold purchases, particularly by the Russian and Chinese central banks, which helped support the price of the precious metal.

It is therefore understandable that each crisis is accompanied by new needs in minerals and the need to secure these new metal sectors.

Metals and Health Issues

Metals have been used for human health for thousands of years. Ayurveda, a traditional medicine that has been practiced for 3,000 years in India, employs lead, mercury and arsenic to treat various ailments. Toxic in excessive quantities, these metals can, however, become indispensable in certain medicines and medical and orthopedic equipment.

Today, pharmacology uses more than a dozen metals or metalloids for various conditions: iron for anemia, bismuth, cobalt and nickel for gastric problems, lithium for depression, antimony for leishmaniasis, platinum or radioactive metals for cancer, arsenic for psoriasis. Gold can even help with the treatment of rheumatoid arthritis.

Metals are also widely used in prostheses: a mouth treated by a dental technician could contain up to 32 different metals! Medical imaging also uses many metals, from X-rays to nuclear medicine. Nuclear magnetic resonance (NMR) is based on rare-earth magnets, while 20 per cent of the world’s gadolinium is used for solutions that increase the contrast of NMR images.

 

 

Metals and the COVID-19 Crisis

And COVID-19? Metals are found in both the prevention and treatment of this new disease.

Copper has been a favorite for creating anti-microbial surfaces, which can reduce hospital outbreaks and kill viruses and bacteria in less than two hours. Zinc can boost the immune system and has already been used against viruses.

Thus, in addition to strategic metals at the heart of conflicts, there are
metals that are essential to health. The COVID-19 pandemic caused shortages of
hygiene and pharmaceutical products. Advanced medical equipment, full of
electronic components and therefore high-value metals, was sometimes lacking.

Most western countries depend on imported metals. It is therefore time to seriously discern what is really indispensable, what essential metals are in the health sector and how to guarantee their supply for use in the next health crises.

 

This article
was republished with permission from The
Conversation, a news site dedicated to sharing ideas
from academic experts.  Written by:

Michel Jébrak, Professeur émérite en ressources minérales, Université du Québec à Montréal (UQAM)

Jack-Pierre Piguet

Professeur, Laboratoire GeoRessources,
Université de Lorraine

Yann Gunzburger

Professeur des universités, laboratoire GeoRessources, Université de Lorraine

 

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