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:) (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”.
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Source: Tetra Bio-Pharma
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Forward-looking statements
Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words "may", "will", "should", "continue", "expect", "anticipate", "estimate", "believe", "intend", "plan" or "project" or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company's ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company to obtain sufficient financing to execute the Company's business plan; competition; regulation and anticipated and unanticipated costs and delays, the success of the Company's research and development strategies, including the success of this product or any other product, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions and other risks disclosed in the Company's public disclosure record on file with the relevant securities regulatory authorities. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.
For further information, please contact Tetra Bio-Pharma Inc.:
Investor Contact:
Pascal Nigen
Alpha Bronze, LLC
Mr. Pascal Nigen
Phone : + 1 (646) 255-0433
