Strong Ph II results for Roche vismodegib in advanced basal cell carcinoma

Swiss drug major Roche (SIX: ROG) said yesterday that a pivotal Phase II clinical study of its investigational Hedgehog Pathway Inhibitor, vismodegib (RG3616/GDC-0449), showed positive results in people with advanced basal cell carcinoma (aBCC), a particularly severe and debilitating form of skin cancer.

The drug is being developed by Roche’s Genentech subsidiary and uses USA-based Curis' (Nasdaq: CRIS) Hedgehog signaling pathway technology. Shares of Curis, which is eligible for regulatory milestones and royalties on eventual sales of the drug,  leapt 17% to $3.44 in Monday morning trading. Roche anticipates making at least one regulatory submission in 2011 on the drug, potential revenue from which for this indication is expected to be below $500 million if approved.

The study met its primary endpoint (overall response rate), of showing vismodegib shrank tumors in a pre-defined percentage of people in the study. A preliminary safety assessment showed the most common adverse events were consistent with previous experience with vismodegib. A detailed safety assessment is ongoing, said Roche.