Ceapro Inc. Initiates Phase 1-2a Study Assessing Its Flagship Product Avenanthramides for Potential Applications in Inflammation Based Diseases
November 27 2023 - 9:15AM
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.
For more information
contact: Jenene Thomas JTC Team,
LLC Investor Relations and Corporate Communications
Advisor T (US): +1 (833) 475-8247 E: czo@jtcir.com
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
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