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Tetra Bio-Pharma Receives FDA Orphan Drug Designation for Hepatocellular Carcinoma
Tetra Bio-Pharma Receives FDA Orphan Drug Designation for Hepatocellular Carcinoma.
About this update from Tetra Bio-pharma Inc.
[{"type":"text","content":"\n Tetra to launch Phase 2 trial for treatment of hepatocellular carcinoma in Q1 2020              Tetra leverages Caumz™-kit technology to provide a new drug for cancer treatment OTTAWA, Dec. 04, 2019 (GLOBE NEWSWIRE) --  Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TSX-V:TBP) (OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development, today announced it has received U.S. Food and Drug Administration (FDA) Orphan Drug Designation for delta-9-tetrahydrocannabinol (THC) in the treatment of hepatocellular carcinoma. “We are very pleased to have received Orphan Drug Designation (ODD) from the FDA for THC. This second ODD for cannabinoids demonstrates our innovation and successful drug development program that will soon include hepatocellular carcinoma,\" said Dr. Guy Chamberland, CEO and Chief Regulatory Officer of Tetra Bio-Pharma. “We intend to bring a modified formulation of Caumz™ for hepatocellular carcinoma into clinical trials in Q1 2020. As previously announced, we in-licensed the formulation technology and the intellectual property rights for the selective distribution of cannabinoids to brain cancers that overexpress CD44.” Tetra will leverage the pharmacokinetic and safety data from its Caumz™ Phase 1 clinical trials to support its Phase 2 trial of a modified formulation Caumz™ in patients with advanced hepatocellular carcinoma. Tetra intends to initiate this new trial in the first quarter of 2020.  “We are thrilled that we can bring this new cancer therapy to Phase 2 clinical trials with no additional drug development costs to Tetra’s shareholders,” Dr. Chamberland noted. “The Caumz™-kit technology already exists, so we will maximize our investment in the development of inhaled cannabinoid drugs to bring another drug to the market.\" Arrangements with Respect to Promotional and Investor Relations Activities Finally, pursuant to Policy 3.4 – Investor Relations, Promotional and Market-Making Activities of the TSX Venture Exchange (the “Exchange”), Tetra wishes to disclose certain past arrangements with respect to promotional activities and “Investor Relation Activities” (within the meaning of the...