Proposed clinical development pathway confirmed by FDA
Ottawa, Ontario, June 17, 2019 (GLOBE NEWSWIRE) — Tetra Bio-Pharma Inc., (“Tetra” or the “Company”) a leader in cannabinoid-derived drug discovery and development (TSX VENTURE:TBP) (OTCQB:TBPMF) today announced that it conducted a Type B meeting with the United States Food and Drug Administration (FDA) for its noncontrolled cannabinoid drug product PPP003 slated for the treatment of painful dry eye. The purpose of the meeting was to obtain confirmation of the Phase II clinical study design and the quality and toxicology requirements for initiating this trial in patients in the USA.
The FDA confirmed the proposed quality information requirements for initiating the Phase II trial in patients. This included a container closure system, stability plans, drug substance and drug product specifications. The FDA also provided feedback on the GLP toxicology requirements to initiate the Phase II trial.
The FDA reviewed the proposed Phase II clinical study and agreed that it was acceptable to evaluate the safety and efficacy of PPP003 Ophthalmic Solution for the treatment of the signs and symptoms of painful dry eye. The FDA also provided guidance on acceptable primary and secondary endpoints.
“This program is a corporate priority for Tetra and Panag since there is a significant unmet medical need for ophthalmic drugs,” said Dr. Guy Chamberland, CEO and CSO of Tetra Bio-Pharma. “The choice of the non-controlled cannabinoid was important as the Company is aiming for global market penetration. We are extremely pleased that the U.S. FDA validated our ophthalmic research program. This program confirms that our research and development team is on the right track. With this confirmation and guidance, Tetra can now complete the execution of the clinical program for PPP003 intended to target the same important dry eye market as Xiidra™ which was recently acquired by Novartis from Takeda for $3.4Bn with $1.6Bn in potential milestone payments.”
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 authorized, and FDA reviewed, clinical trials 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 cannabinoids 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.
For more information visit: www.tetrabiopharma.com
Source: Tetra Bio-Pharma
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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 or any other clinical trial, 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. While no definitive documentation has yet been signed by the parties and there is no certainty that such documentation will be signed. 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.
Senior Vice President, Marketing and Medical Affairs
Carol Levine, APR, FCPRS CEO
514-288-8500 ext. 226