May 1, 2012

Further CEO Letter Thoughts: Liver Metastasis

We are conducting nonclinical drug-drug interaction studies to verify safety of combining PV-10 with sorafenib, the standard of care for nonresectable locally advanced primary liver cancer. This supports advanced development of PV-10 for HCC in clinical studies comparing PV-10 with the standard of care versus the standard of care alone, to demonstrate an overall survival benefit of treating HCC with PV-10. We expect to provide further guidance on this important indication when we are closer to commencing a Phase 2 or Phase 2/3 clinical study.
Although PV-10 is demonstrably proven to be safe and the active pharmaceutical ingredient is well known to the FDA, non-clinical drug-drug interaction studies were conducted to confirm the orthogonality of PV-10 and sorafenib; that is, the lack of interaction between the two drugs when administered together. The contemplated HCC Phase 2 or Phase 2/3 trial the company will compare sorafenib and {PV-10 plus sorafenib}.

Orthogonal refers to the the idea of perpendicular, non-overlapping, independently varying or uncorrelated items.

Sorafenib causes the levels of certain enzymes in the liver to be elevated. As a result, the work was necessary to successfully confirm there was no metabolic drug-drug interaction between PV-10 and sorafenib.

No comments:

Post a Comment