Business
Tetra Bio-Pharma Provides Update on its Hepatocellular Carcinoma Drug HCC011
Tetra Bio-Pharma Provides Update on its Hepatocellular Carcinoma Drug HCC011.
About this update from Tetra Bio-pharma Inc.
[{"type":"text","content":"\n Orphan Drug Designation qualifies Tetra for certain incentives and benefits, including a 50% tax credit upon approval               Tetra to pursue 505(b)(2) NDA pathway and expedited review for its Orphan Drug candidate HCC011 OTTAWA, Dec. 10, 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 will be requesting a meeting with the U.S. Food and Drug Administration (FDA) to discuss the drug development program for its Orphan Drug candidate HCC011, inhaled delta-9-tetrahydrocannabinol (THC), in the treatment of hepatocellular carcinoma. Hepatocellular carcinoma (HCC), also known as primary liver cancer, is the most common form of liver cancer and is responsible for 80 percent of the primary malignant liver tumors in adults.  In addition to quality of life benefits to cancer patients, based on preclinical research, HCC011 should also have antitumor effects.  The Phase 2 study of HCC011 will target patients with disease progression on Sorafenib, have measurable disease, and Child-Pugh Class A liver impairment.  The Phase 2 trial will consist of a single arm.  Patients will receive the HCC011 by inhalation three times daily, in combination with Sorafenib, until disease progression or unacceptable toxicity.  The study design is similar to the ones used by recent drugs seeking accelerated approval.  The Disease control rate will be assessed based on the Response Evaluation Criteria in Solid Tumors (RECIST); the overall survival and time to progression will be closely monitored over time. Patients will also beneficiate of the anti-emetic effect of HCC011, which will participate in improving their quality of life.    The company intends to file an NDA for HCC011 via the 505(b)(2) pathway.  The FDA has three approval pathways by which drugs may gain approval and the 505(b)(2) new drug application (NDA) is one of the three ways created by the Hatch-Waxman Amendments of 1984, with 505(b)(2) referring to a specific section of the U.S. Federal Food, Drug, and Cosmetic Act. The provisions of a 505(b)(2) provide manufacturers who have certain types of drugs with an opportunity to acq...