Ceapro Inc. Announces Dosing of First Patients in Phase 1-2a Study Assessing Flagship Product Avenanthramides for Potential Applications in Inflammation Based Diseases
– Study being led by Dr. Jean-Claude Tardif at the Montreal Heart Institute
– No adverse reactions observed, and study can continue as planned
EDMONTON, Alberta, Dec. 13, 2023 (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 the commencement of patient dosing in its Phase 1-2a study evaluating its flagship product, avenanthramides, for potential applications in managing conditions related to inflammation. No adverse reactions have been observed and the study can be pursued as per protocol design.
“The start of patient dosing in the Phase 1-2a study is a significant accomplishment and step forward in providing a promising new therapeutic in low grade systemic inflammation,” stated Gilles Gagnon, M.Sc., MBA, President and CEO of Ceapro. “We are pleased with this rapid dosing stage of the study being led by Dr. Tardif and his team. We remain dedicated to advancing medical innovation and addressing unmet medical needs.”
The Phase 1-2a study (“AvenActive”) is a double-blind, placebo-controlled, randomized, adaptive, first-in-human study designed to assess safety, tolerability, and pharmacokinetics of single and multiple ascending oral doses of avenanthramide. 72 healthy subjects will be enrolled in the Phase 1 portion of the trial. The single ascending dose (SAD) arm will include 6 cohorts of 8 healthy subjects, while the multiple ascending dose (MAD) arm will include 3 cohorts of 8 healthy subjects. Following the Phase 1 portion, pending successful results, the AvenActive protocol also includes a Phase 2a portion for patients presenting evidence of mild to moderate inflammation. 24 patients would be enrolled in the Phase 2a portion.
The Phase 1-2a trial is designed to evaluate the safety profile of avenanthramides and gather initial insights into its potential efficacy. As the trial progresses, Ceapro remains focused on collaborating with regulatory authorities, healthcare professionals, and patient communities to bring this innovative therapy to market.
About the Montreal Heart Institute
Founded in 1954 by Dr. Paul David, the Montreal Heart Institute constantly aims for the highest standards of excellence in the cardiovascular field through its leadership in clinical and basic research, ultra-specialized care, professional training, and prevention. It houses the largest cardiology research center in Canada, the largest cardiovascular prevention center in the country, and the largest cardiovascular genetics center in Canada. The Institute is affiliated with the Université de Montréal and has more than 2000 employees, including 245 physicians and more than 85 researchers. For more information, please visit www.icm-mhi.org/en. The Montreal Health Innovations Coordinating Center (MHICC) is a leading full-service academic clinical research organization and an integral part of the Montreal Heart Institute (MHI). The MHICC possesses an established network of collaborators in over 4500 clinical sites in more than 35 countries. It has specific expertise in precision medicine, low-cost high-quality clinical trials, and drug repurposing (mhicc.org).
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.
This press release contains forward-looking statements based on our assessment of Ceapro’s future plans and operations as of the date of this press release. Forward-looking statements and information can generally be identified by the use of forward-looking terminology such as ‘may”, “will”, “expect”, “intend”, “estimate”, “anticipate”, “believe”, “continue”, “plans” or similar terminology. By their nature, forward-looking statements are subject to numerous risks and uncertainties. Readers are cautioned that the assumptions used in the preparation of forward-looking information, although considered reasonable at the time of preparation, may prove to be imprecise and, as such, undue reliance should not be placed on forward-looking statements. Actual results, performance, or achievements could differ materially from those expressed in, or implied by, the forward-looking statements in this press release. No assurance can be given that any of the events anticipated will transpire or occur, or if any of them do so, what benefits Ceapro will derive from them. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise unless required by law.
For more information contact:
JTC Team, LLC
Investor Relations and Corporate Communications Advisor
T (US): +1 (833) 475-8247
This press release does not express or imply that the Company claims its product has the ability to eliminate, cure or contain the SARS-2-CoV-2 (COVID-19) at this time.
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 December 13, 2023