HCC011

HCC011 is an orphan drug-designated, inhaled formulation of delta-9-tetrahydrocannabinol (THC) developed as a drug-device combination product for the treatment of hepatocellular carcinoma (HCC). It is intended to be used as an adjunct to first-line therapy in patients with inoperable, advanced HCC. The drug leverages the anti-emetic and quality-of-life benefits of THC, but is also being investigated for its potential anti-tumor effects that may improve patient outcomes and prognosis in liver cancer. The product benefits from Tetra Bio-Pharma’s clinical data on the pharmacokinetics, safety, and pharmacodynamics of inhaled cannabinoids. HCC011 has received Orphan Drug Designation from the FDA and is being developed under a 505(b)(2) regulatory pathway[1][2][4][10].