FDA Approves Advancement of PPP001 Clinical Trial Previously Discontinued

• Company to resume clinical trial in advanced cancer patients with uncontrolled pain
• Tetra engages leading clinical collaborator to run Plenitude trial in the U.S.

OTTAWA, Nov. 25, 2019 (GLOBE NEWSWIRE) -- Tetra Bio-Pharma Inc., (TSX-V: TBP) (OTCQB: TBPMF), a leader in drug discovery and development for cannabinoid-based therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has authorized the advancement of Plenitude, the company’s clinical trial for its investigational therapeutic QIXLEEF™ (PPP001), for the treatment of uncontrolled pain in advanced cancer patients.  The study was allowed to proceed by the FDA after a review of the company’s quality file, including mycotoxin quality information, and after ensuring the safety assessments were adequate to protect patients. Tetra has begun activities to resume this clinical trial program and plans to initiate enrollment as quickly as possible.

“We are very pleased to have been able to provide the FDA with a comprehensive information package which has led to the FDA’s authorization and Tetra’s initiation of our Plenitude trial,” said Guy Chamberland, CEO and Chief Regulatory Officer of Tetra Bio-Pharma Inc.  “We will be working in the coming weeks to launch the trial as quickly as possible.”

Plenitude is a 4-week double-blind, randomized, placebo-controlled, parallel group design trial to evaluate the safety and efficacy of inhaled PPP001 on uncontrolled cancer pain in 78 adult patients with symptoms related to advanced incurable cancer and uncontrolled pain related to cancer.  The company anticipates results from the Plenitude clinical trial will be part of the drug approval package for QIXLEEF.

In connection with launching this clinical trial, Tetra is accelerating plans to sign a commercial partner in the U.S. for the distribution and sale of QIXLEEF. The company is working closely with its partners to ensure clinical and commercial readiness and has signed a research collaboration agreement with Dr. Sue Sisley, M.D., an Arizona-based physician practicing Internal Medicine and Psychiatry and the leading international advocate for the benefits of whole-plant based cannabis therapies and a recognized expert in post-traumatic stress disorder (PTSD). 

Tetra began working with Dr. Sisley several months ago.  Her cannabis clinic holds a Schedule 1 license for inhaling cannabis from the US Drug Enforcement Agency (DEA).  With the study authorized, Dr. Sisley and Tetra’s clinical research team intend to amend the DEA license to add the Plenitude trial to allow for Dr. Sisley’s clinical site to run the trial.  The Company anticipates this amendment will be completed within a few weeks. 

"We are very fortunate to collaborate with Dr. Sisley and believe she will play an important role in educating physicians on the therapeutic potential of vaporized dried flower bud. Dr. Sisley’s expertise and advocacy will be key for any partner distributing QIXLEEF in the U.S. or globally," said Mr. Chamberland. “Additionally, we believe Dr. Sisley will be instrumental in helping with trial enrollment and patient analysis.”

QIXLEEF is the company’s first-generation cannabinoid therapeutic in development for treating advanced cancer patients with uncontrolled pain. The company believes a subset of the advanced cancer patient population prefers to consume cannabis in the traditional way, using dried flower bud as a drug product.  In early 2019, Tetra uncovered an impurity in the dried flower bud cannabis and worked diligently to find solutions to develop a pharmaceutical grade cannabis drug free of any traces of the impurity.  

Through this research, the company has also developed a second-generation medicinal product, Caumz^TM, which is currently in development for patients with advanced cancer pain. 

Mr. Chamberland concluded, "I am extraordinarily proud of our Research & Development and Quality and Compliance teams. We have worked diligently to get FDA authorization for the trial and revive QIXLEEF, and we have also been able to leverage the investment in our research to bring two generations of inhaled cannabinoid and cannabis drugs to patients."

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, 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.

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Source: Tetra Bio-Pharma

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