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PBG BioPharma Inc. Announces the launch of a Phase 2/3 Clinical Trial on its Cannabinoid-based Drug Product ProZ-001 as an Adjunctive Therapy for Acute Bipolar Depression

Updated: Mar 28

VANCOUVER, British Columbia, February 27, 2024 – PBG BioPharma Inc. (PBG), a leading phytochemical biopharmaceutical company specializing in developing innovative therapeutical and nutraceutical products, today announced that the University of British Columbia (UBC) is officially launching the Canadian Institutes of Health Research funded Phase 2/3 clinical trial, which will use the company's cannabinoid drug product ProZ-001.


The trial, approved by Health Canada, which will be conducted at multiple sites across Canada, is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of PBG’s cannabinoid product ProZ-001 as an adjunctive therapy in patients with Acute Bipolar Depression. The trial will enroll approximately 360 patients, over a period of several years, and is expected to begin enrollment immediately.


Bipolar Disorder is a chronic mental health condition characterized by extreme mood swings, including episodes of mania and depression. It affects millions of people worldwide and can have a significant impact on their quality of life. Despite the availability of some treatment options, there remains a significant unmet need for more effective and well-tolerated therapies.


"Bipolar disorder is a complex condition, with depression often posing the greatest burden for patients,” says Dr. Lakshmi Yatham, professor and head of UBC’s department of psychiatry and the study’s principal investigator. "This trial marks a significant step forward in exploring innovative, much-needed treatments for bipolar disorder.”


Cannabinoid-based products have shown promising results in earlier clinical trials. This trial will build on these results and provide additional data on the safety and efficacy of the product in a larger patient population.


“PBG is committed to unlocking the health and therapeutic benefits of medicinal plants including Cannabis. We are thrilled that our cannabinoid-based drug product Proz-001 is being used in a Phase 2/3 clinical trial conducted by leading medical expert Dr. Yatham and his team at the University of British Columbia and other medical researchers from world class universities across Canada," said Dr. Jacqueline Shan, CEO and President of PBG. “We look forward to working with the clinical investigators to advance this important medical research."


About PBG BioPharma Inc.

PBG BioPharma Inc. is a vertically integrated biopharmaceutical company focusing on the research, development, and manufacturing of biopharmaceuticals and nutraceuticals. The company takes a pharmaceutical approach to its product development, testing and manufacturing process for premium quality, pharmaceutical grade ingredients and formulations. PBG has established 70,000 square foot state-of-the-art, GMP standard biopharmaceutical production and lab facilities, and amassed a large licence portfolio, including a Cannabis Standard Processing Licence with Sale Amendment Licence, Medical Cannabis Sales License, a Cannabis Analytical Licence, 4 Cannabis Research Licences including an Institutional Wide Research Licence, GMP Drug Establishment licence, GMP NHP Site Licence, Controlled Drug and Substances Dealer’s Licence, and ISO 17025 certification, which will allow the company to provide point-to-point business from clinical research to product development/testing and manufacturing. PBG is currently conducting research and therapeutic development in the areas of mental health disorders, neuropathic pain and broad-spectrum anti-viral. PBG also has several product lines on the market, including the GenBioChem® line of natural health products, and various plant-based active pharmaceutical ingredients such as various cannabinoids and psilocybin for related industry application and clinical research.


About the University of British Columbia (UBC) Faculty of Medicine

Ranked among the world’s top medical schools with the fifth-largest MD enrollment in North America, the UBC Faculty of Medicine is a global leader in both the science and the practice of medicine. Guided by our vision—to transform health for everyone—our faculty, learners, staff and alumni are accelerating discovery and creating pathways to better health for Canada and beyond. Through collaboration with our partners, we strive to meet the demands of today and tomorrow, bringing real and lasting hope to people everywhere. For more information, visit med.ubc.ca or follow us on X, formerly known as Twitter: @UBCmedicine.


SOURCE: PBG BioPharma Inc.

For further information, please contact:

PBG BioPharma Inc.

Clinical Affair Telephone: +17809809801 ext.104


UBC communications contact

Brett Goldhawk

UBC Faculty of Medicine

Telephone: 778-952-7858


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