Tetra Biopharma Confirms Type B Meeting Date With FDA Regarding HCC011

FDA Grants Type B meeting to discuss Tetra’s HCC011 with Orphan Drug Designation

OTTAWA, April 06, 2020 (GLOBE NEWSWIRE) -- Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TSX-V:TBP) (OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development, is pleased to announce that the U.S. Food & Drug Administration ("FDA") has granted the Company’s request for a Type B meeting related to its proposed clinical program and overall premarketing requirements for the Company’s product HCC011 with Orphan Drug Designation. This meeting has been scheduled for May 29, 2020.

HCC011 is an inhaled delta-9-tetrahydrocannabinol (THC) formulation to be developed as an adjunct treatment to first-line therapy to improve disease control in inoperable, advanced hepatocellular carcinoma patients. In addition to its anti-emetic effect and its capacity to enhance patient health-related quality of life, HCC011 should also have anti-tumor effects, improving patient outcome and prognosis in their battle against liver cancer.

According to Dr. Guy Chamberland, CEO and Chief Regulatory Officer of Tetra, "in December 2019 news release, we revealed our intention to submit the request for a Type B meeting with the FDA.  Earlier this year, our regulatory and clinical team prepared the submission and last week we received confirmation that the meeting with FDA had been granted.  On May 29, the FDA will be providing guidance on our planned phase 2 clinical trial, expedited review paths, and 505(b)(2) premarketing requirements.  Tetra also plans to provide the FDA with data from our ongoing metabolite study".

About Tetra Bio-Pharma

Tetra Bio-Pharma (TSX-V:TBP) (OTCQB:TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a Health Canada approved, and FDA reviewed and approved, clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. The Company has several subsidiaries engaged in the development of an advanced and growing pipeline of Bio Pharmaceuticals, Natural Health and Veterinary Products containing cannabis and other medicinal plant-based elements. With patients at the core of what we do, Tetra Bio-Pharma is focused on providing rigorous scientific validation and safety data required for inclusion into the existing bio pharma industry by regulators, physicians and insurance companies. Could we work in “existing regulatory standards of safety and clinical evidence for pharmaceutical products”.