On June 2, 2020 Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSXV:TBP)(OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development, reported that it has completed a Type B meeting with the United States Food and Drug Administration (FDA) for its drug-device combination product HCC011, slated for the treatment of hepatocellular carcinoma (HCC) (Press release, Tetra Bio Pharma, JUN 2, 2020, View Source [SID1234561076]). This product has received an orphan drug designation for the treatment of HCC.

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The FDA provided guidance on the nonclinical safety and human clinical pharmacology, safety and efficacy requirements to seek marketing approval for HCC011 as an anticancer treatment. The FDA agreed with Tetra’s proposed nonclinical safety program to support the clinical development program and a New Drug Application (NDA).

The FDA also agreed with Tetra that a food effect study is not required for HCC011 as absorption mainly occurs in the lung and is therefore not affected by the liver first pass metabolism effect. This was also confirmed by Health Canada.

Several anticancer drugs have obtained accelerated approval by the FDA based on the outcome of a single arm trial. Tetra requested guidance from the FDA on this potential path, including the development of HCC011 as an adjunct to Sorafenib, as we believe that the drug-drug combination would result in a superior outcome in patients. The FDA provided a response to the proposed trials and options. Tetra must demonstrate the effect of HCC011 on tumor progression as a monotherapy before aiming for developing HCC-011 as an adjunct to Sorafenib. The FDA preferred an efficacy endpoint of Overall Survival for marketing applications seeking regular approval for the treatment of patients with advanced unresectable or metastatic HCC. In addition, they stated that Progression-Free Survival (PFS) may be considered in support of regular or accelerated approval, depending on the magnitude of PFS improvement, provided that it is accompanied by an acceptable risk-benefit profile and no decrement in overall survival.

"We are very pleased with the detailed feedback of Friday’s meeting with the U.S. FDA. Tetra’s clinical research team can now launch the development program." said Guy Chamberland, Chief Executive Officer and Chief Regulatory Officer of Tetra Bio-Pharma. "Since the demonstration of the liver toxicity of Epidiolex, we have observed that both the FDA and Health Canada are asking more and more questions on the safety of phytocannabinoid-derived drugs and requiring stricter inclusion-exclusion enrolment criteria and patient monitoring tests and frequency to ensure the safety and well-being of study subjects. On April 2nd 2020, we announced the launch of a clinical study to map out the cannabinoid metabolites in humans following inhalation of QIXLEEFTM and CAUMZTM. The same testing will be extended to HCC011. We hope to demonstrate a safer metabolism profile when CBD and THC are taken by the inhalation route over the oral or sublingual routes. If favorable, this will provide important data to the regulators regarding the safety of inhaled phytocannabinoids."