Ceapro Inc. Initiates Phase 1-2a Study Assessing Its Flagship Product Avenanthramides for Potential Applications in Inflammation Based Diseases
- Avenanthramides have garnered significant interest due to their suggested bioactivities, including potent antioxidant and anti-inflammatory effects.
- The Phase 1-2a study 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.
- The study will evaluate biomarkers of inflammation in blood, with a particular emphasis on pro-inflammatory cytokines, chemokines, and other inflammatory markers such as high sensitivity C-reactive protein.
- None.
Study being led by Dr. Jean-Claude Tardif at the Montreal Heart Institute
Screening of healthy subjects is now underway
Phase 1-2a study to provide valuable insights into the safety and activity of avenanthramides in managing conditions related to inflammation
EDMONTON, Alberta, Nov. 27, 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 and disruptive technologies for healthcare and cosmetic industries, announced today the initiation of its Phase 1 study evaluating its flagship product, avenanthramides, for potential applications in managing conditions related to inflammation.
Avenanthramides, di-phenolic compounds found exclusively in oats, have garnered significant interest due to their suggested bioactivities, including potent antioxidant and anti-inflammatory effects both in vitro and in vivo.
This 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. Dr. Jean-Claude Tardif’s team is now actively screening healthy subjects for the first SAD cohort. Subjects will be under observation in a clinical setting and initial dosing is anticipated in early December 2023.
Dr. Jean-Claude Tardif, the principal investigator of the study and Director of the Research Center at the Montreal Heart Institute stated, "We are excited to explore the potential therapeutic benefits of avenanthramides and believe results from this study could mark a significant step forward in understanding the potential of avenanthramides in cardiovascular disease. Not only will the study assess safety of avenanthramides in healthy subjects, but it could also provide early signs of activity in subjects with low grade inflammation as part of the Phase 2a component. The results of such studies will provide valuable insights into the potential role of avenanthramides in reducing vascular inflammation and may have implications for cardiovascular health.”
Published data has indicated that polyphenols, such as avenanthramides, may act as modifiers of signal transduction pathways, exhibiting beneficial effects. These natural compounds are known to express anti-inflammatory activity by modulating the expression of proinflammatory genes, including cyclo-oxygenase, lipoxygenase, nitric oxide synthases, and key cytokines. The AvenActive study will focus on evaluating biomarkers of inflammation in blood, with a particular emphasis on pro-inflammatory cytokines, chemokines, and other inflammatory markers such as high sensitivity C-reactive protein.
"Ceapro is thrilled to advance this groundbreaking research. A number of studies have suggested that avenanthramides may exert anti-inflammatory effects on the vascular system through various mechanisms and we look forward to better decipher those pathways. Initiation of this study marks another step in expanding our business as a biopharmaceutical company. Pending successful results in the Phase 1 and potential Phase 2a study, we believe we will be well-positioned for out-licensing opportunities for later stage development and commercialization. With significant market potential and patient benefit, we believe avenanthramides is poised to be the biggest product for Ceapro,” concluded Gilles Gagnon, M.Sc., MBA, President and CEO of Ceapro.
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 https://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 (https:/www.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.
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