Ceapro Inc. Receives Approval from Health Canada to Commence Human Clinical Study Assessing Beta Glucan as a Cholesterol-Lowering Agent
– Ceapro is Pioneering approach with a natural product as add-on therapy to a prescription product
– First of the clinical studies being conducted as part of collaboration with the Montreal Heart Institute led by MHI’s Montreal Health Innovations Coordinating Center (MHICC)
EDMONTON, Alberta, Oct. 09, 2018 (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 it has received approval from Health Canada to initiate its comparison study evaluating high-medium molecular weight beta glucan as an add-on therapy to statins in subjects with hyperlipidemia.
The study will be conducted with the Montreal Heart Institute (MHI) as part of the long-term collaboration announced earlier this year. As announced, this agreement will consist of multiple projects, the first of which is this clinical study assessing Ceapro’s beta glucan as a cholesterol-lowering agent.
“Given the well-known health claims of beta glucan and the increased awareness of the link between diet and health, we believe this study will offer insight into a new potentially beneficial approach for patients to lower plasma cholesterol”, commented Dr. Jean-Claude Tardif, Director of the Montreal Heart Institute Research Center and Principal Investigator for this clinical trial.
The 280-patient study will be a multicenter, randomized, double-blind, parallel group, placebo-controlled study to compare the efficacy and safety of high-medium molecular weight beta glucan as add-on therapy to statins in subjects with hyperlipidemia (LDL-C level >130 mg/d L (3.37 mmol/L). The 18-24-month study will enroll approximately 280 subjects who cannot tolerate high doses of current treatments. Patients enrolled will be randomized to receive either placebo, low, medium or high doses of beta glucan (500 mg tablet) as add-on therapy to atorvastatin 10 mg - 20 mg or an equivalent statin for a 12-week treatment period. The primary efficacy endpoint of the study will be the change over 12 weeks in LDL-cholesterol.
“The commencement of this study represents a noteworthy milestone in the development of our beta glucan program and could be the most significant transformational step we have taken to date in executing on our strategy to transition Ceapro’s business model towards becoming a biopharmaceutical company with the potential to provide an innovative product in a multi-billion dollar and growing market. On the technical side, we are pleased with the final formulation of beta glucan powder, which has been produced in house using our disruptive PGX technology and additionally with the final tablet developed with Montreal-based specialty pharmaceutical companies, Corealis and Halo Pharma, who respectively completed the pharmaceutical development and the production of clinical lots for the trial. We are extremely grateful to be working with the expert team led by Dr. Tardif at MHI and MHICC, who shares a synergistic goal in Ceapro’s contemplated sector of activities in inflammation-based diseases, metabolic syndrome and other lifestyle diseases,” added Gilles Gagnon, M.Sc., MBA, President and CEO of Ceapro.
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 Communications, LLC
Investor Relations and Corporate Communications Advisor
T (US): +1 (833) 475-8247
Gilles R. Gagnon, M.Sc., MBA
President & CEO
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Released October 9, 2018