Ceapro Inc. Announces Approval from Health Canada for Protocol Expansion of Current Clinical Study Assessing Beta Glucan as a Cholesterol-Lowering Agent
– Ongoing clinical study evaluating the well-known health claims of beta glucan and its potentially beneficial approach for patients to lower plasma cholesterol –
– Amendment to existing protocol approved to add subjects voluntarily limiting treatment to beta glucan only –
– Protocol expansion expected to accelerate patient enrollment and expand target addressable patient population –
– Patient enrollment expected to be completed by January 2021 –
EDMONTON, Alberta, Feb. 05, 2020 (GLOBE NEWSWIRE) -- Ceapro Inc. (TSX-V: CZO; OTCQX: CRPOF) (“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 expand the inclusion criteria of its comparison study evaluating high-medium molecular weight beta glucan as an add-on therapy to statins in subjects with hyperlipidemia. While the total number of patients will remain the same, this expansion will 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.
“The protocol expansion of this important clinical study represents what we believe is a game-changing opportunity to validate the well-known health benefits of beta glucan. The use of oat beta glucan as a potential lipid lowering agent is met with marked interest in the patient population. Adjusting the inclusion criteria of the study has both scientific and clinical value. We are very pleased with the decision of Health Canada to allow this patient-driven addition to the protocol and we are extremely grateful to be working with the expert team led by Dr. Jean-Claude Tardif at the Montreal Heart Institute who worked closely with Health Authorities in making this significant change accepted,” commented Gilles Gagnon, M.Sc., MBA, President and CEO of Ceapro. “We remain focused on the successful execution of our transition towards becoming a biopharmaceutical company and look forward to advancing the development of this pioneering program.”
“Beta glucan is a promising approach as an additional potential therapy to help lower plasma cholesterol in patients with hyperlipidemia. We are very pleased to be adding an extension to this study to evaluate the potential of beta glucan as a stand-alone treatment and look forward to seeing the full potential of this beneficial approach and, hopefully, offer an alternative to the current treatment paradigm for patients and physicians,” 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 will enroll approximately 264 subjects who cannot tolerate high doses of current treatments. Patients enrolled are 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 will be the change over 12 weeks in LDL-cholesterol.
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 www.ceapro.com and connect with the Company on Twitter, Facebook and LinkedIn.
For more information contact:
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 February 5, 2020