FORT LAUDERDALE, FL / ACCESSWIRE / July 26, 2023 / Organicell Regenerative Medicine, Inc. (OTCQB:OCEL), a clinical-stage biopharmaceutical company focused on the development of innovative biological regenerative therapeutics, today reported the results of its Phase 1/2A research program for its biologic therapeutic, ZofinTM, which contains high concentrations of nanoparticles, including exosomes, growth factors, and bio-active proteins. These results focus on the safety outcomes across three separate studies.
Organicell has completed a Phase 1 study in knee osteoarthritis and a second study in patients with moderate-to-severe COVID-19. In addition, a trial involving patients with "long-haul" COVID-19 acquired sufficient data to end additional patient enrollment earlier this year and is expected to be completed in October 2023.
Notably, across all three studies, with over 20 patients treated with ZofinTM (not including a similar number of patients treated with placebo), there have been no reported therapy-related safety events or significant adverse events.
Howard Golub, M.D., Ph.D., Organicell's Chief Science Officer stated, "Building on other reported clinical studies, the aggregate results of our Phase 1 program demonstrate that our biologic therapeutics, containing hundreds of billions of bioactive nanoparticles, have a highly favorable safety profile. This positions us well to move onto larger Phase 2 studies for multiple chronic conditions in 2024."
"Organicell is committed to conducting the highest quality research with the goal of demonstrating that our biologic therapies are both safe and effective," said Harry Leider, M.D., M.B.A, Chief Executive Officer of Organicell. Dr. Leider added, "the positive results of our Phase 1 program are a foundational step enabling us to now move forward to demonstrate the effectiveness of our novel therapeutics in larger Phase 2 studies which is the next major step toward obtaining FDA approval for our innovative biologic therapies."
About Organicell Regenerative Medicines, Inc.
Organicell Regenerative Medicine, Inc. (OTCQB:OCEL) is a clinical-stage biopharmaceutical company principally focusing on the development of innovative biological therapeutics for the treatment of chronic diseases and the provision of related services. The Company's proprietary products are derived from perinatal sources and are manufactured to retain the naturally occurring bioactive exosomes, hyaluronic acid, and proteins without the addition or combination of any other substance or diluent. To learn more, please visit https://organicell.com/
Forward-Looking Statements
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SOURCE: Organicell Regenerative Medicine, Inc.