HCC011 is an orphan drug designated drug-device combination product for the treatment of hepatocellular carcinoma (HCC)
OTTAWA, ON / ACCESSWIRE / June 2, 2020 / Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSXV:TBP)(OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development, is pleased to announce 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). This product has received an orphan drug designation for the treatment of HCC.
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."
About Tetra Bio-Pharma
Tetra Bio-Pharma (TSXV: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.
For more information visit: www.tetrabiopharma.com
Source: Tetra Bio-Pharma
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Forward-looking statements
Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words "may", "will", "should", "continue", "expect", "anticipate", "estimate", "believe", "intend", "plan" or "project" or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company's ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company to obtain sufficient financing to execute the Company's business plan; competition; regulation and anticipated and unanticipated costs and delays, the success of the Company's research and development strategies, including the success of this product or any other product, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions and other risks disclosed in the Company's public disclosure record on file with the relevant securities regulatory authorities. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.
For further information, please contact Tetra Bio-Pharma Inc.:
Investor Contact:
Alpha Bronze, LLC
Mr. Pascal Nigen
Phone: + 1 (646) 255-0433
[email protected]
Media Contact:
energi PR
Ms. Carol Levine APR, FCPRS
Phone: + 1 (416) 425-9143 ext. 226
Mobile: + 1 (514) 703-0256
[email protected]
SOURCE: Tetra Bio-Pharma