"Formulation:
In planning for an extension into a Phase 2a (subject to Phase 1 outcomes in terms of safety and selected dose), the Ceapro R&D group manufactured sufficient additional GMP batches of avenanthramides active ingredient powder for a second formulation of avenanthramides pills. The second GMP clinical batches will also be manufactured, packaged and labeled in 2023 by Corealis Inc. GMP Manufacturing Services."
CZO had previously mentioned that it could use avenanthramide in combination with one of its newer carriers. Could CZO impregnate PGX-Alginate with avenanthramide to create a slow-release formulation? CZO could have not only the first pharma grade, potent avenanthramide pill but a slow-release formulation. Avenanthramide has been investigated for many potential applications by others. Combining avenanthramide with PGX-YBG-Alginate could further add additional anti-inflammatory properties given the anti-inflammatory properties of PGX-YBG.
CZO's last news release said it received an Acknowledgement Letter from Health Canada sometime after the Quarter ending September 30 and approval is expected within 90 days.We could almost be there. The move from preclinical to clinical is a significant de-risking event. If safety is already in the bag only efficacy may be left and there could be indications of that early.
Nov. 9, 2022 News Release:
"Clinical Trial:
Subsequent to quarter, the Company received an Acknowledgement Letter from Health Canada confirming complete information and material to support a Clinical Trial Application (CTA) for Phase 1/2a study entitled “Ceapro Inc Avenanthramide (AVA): A Double-Blind, Placebo-Controlled, Randomized, Adaptive, First-in-Human Study to Assess Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of Avenanthramide (AvenActive).” A response from Health Canada for clearance to proceed with this study is expected to be received within 90 days."