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FDA Approves Advancement of PPP001 Clinical Trial Previously Discontinued
FDA Approves Advancement of PPP001 Clinical Trial Previously Discontinued.
About this update from Tetra Bio-pharma Inc.
[{"type":"text","content":"\n Company to resume clinical trial in advanced cancer patients with uncontrolled painTetra 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 wit...