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:
JTC Team, LLC
Investor Relations and Corporate Communications Advisor
T (US): +1 (833) 475-8247
Gilles R. Gagnon, M.Sc., MBA
President & CEO
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
Released May 26, 2021