Tetra Bio-Pharma 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 said. "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."
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