Incuron Announce CBL0102 Orphan Drug Status for Hepatocellular Carcinoma
A multi-center Phase I trial of CBL0102 is ongoing in the Russian Federation in patients with liver metastases of solid tumors of epithelial origin, or primary advanced hepatic carcinoma for which standard therapy has failed or does not exist. The trial is dosing the sixth cohort in its dose-escalation arm and, subsequent to the completion of the dose-escalation arm, will enroll an efficacy arm.
There are approximately 30,000 U.S. and 45,000 E.U. annual cases of hepatocellular carcinoma, with an overall survival rate of approximately 15%.
CBL0102 is an orally administered small molecule that acts by blocking activity of chromatin remodeling complex FACT, resulting in simultaneous modulation of three signal transduction pathways (p53, NF-kappaB and heat shock response) commonly deregulated in cancer.