QIXLEEF OTTAWA / ACCESSWIRE / April 14, 2020 / Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TBP.V) (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.
About QIXLEEF™
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™.