DEA Renews Schedule 1 License for Scottsdale Research Institute (Plenitude clinical site)
OTTAWA / ACCESSWIRE / April 14, 2020 / 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 Dr. Sue Sisley's Scottsdale Research Institute received the renewal of its Schedule 1 license from the US Drug Enforcement Agency (DEA). The receipt of the DEA Schedule 1 license is a significant milestone in the advancement of the Plenitude trial and ultimately getting QIXLEEF™ into the market. A fully licensed facility allows Tetra to commence the process of having a licensed producer ship the necessary GMP grade dried pellets containing cannabinoids to the clinical site prior to the start of patient enrollment.
"We are very pleased that Dr. Sue Sisley has received the DEA license. This is the last step before initiating the treatment phase of the Plenitude trial. We will now focus and accelerate getting QIXLEEF™ to Dr. Sisley," said Guy Chamberland, CEO and Chief Regulatory Officer of Tetra Bio-Pharma Inc.
In November 2019, the U.S. Food and Drug Administration (FDA) authorized the advancement of Plenitude, the company's clinical trial for its investigational therapeutic QIXLEEF™, for the treatment of uncontrolled pain in advanced cancer patients. Tetra had begun activities to resume this clinical trial program and today we are excited to announce the granting of the renewed Schedule 1 license from the DEA that is required to initiate patient treatment with QIXLEEF™.
Plenitude is a 4-week double-blind, randomized, placebo-controlled, parallel group design trial to evaluate the safety and efficacy of inhaled QIXLEEF™ 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™.
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 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".
For more information visit: www.tetrabiopharma.com
Source: Tetra Bio-Pharma
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For further information, please contact Tetra Bio-Pharma Inc.:
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Mr. Pascal Nigen
Phone: + 1 (646) 255-0433
SOURCE: Tetra Bio-Pharma Inc.