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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, CaumzTM, 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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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 this trial, the ability to obtain orphan drug status, 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.

Investor Contact:
Bruce Mackle
LifeSci Advisors LLC

Media Contact:
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LifeSci Public Relations

Carol Levine
Energi PR
514-288-8500 ext. 226 


Source: Tetra Bio-Pharma

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