Curis, Genentech Begin Phase II Skin Cancer Trial

Curis, Inc. and Genentech have initiated a Phase II trial of GDC-0449, an orally-administered small molecule Hedgehog Pathway Inhibitor, as a single-agent therapy for patients with operable basal cell carcinoma (BCC).

The companies continue to work with clinical investigators to evaluate GDC-0449 in other diseases with Hedgehog-pathway mutations such as medulloblastoma, a childhood brain cancer and in BCCs in basal cell nevus (Gorlin) syndrome, a rare genetic disorder in which patients typically develop multiple BCCs over their lifetime.

Genentech/Roche is developing GDC-0449 in advanced BCC, a severe form of the disease that includes cutaneous BCCs that are inoperable and have metastasized to other tissues and organs. Previously reported data from a Phase I trial in patients suffering from advanced BCC showed a 55% response rate in 33 advanced BCC patients. Enrollment in a 100-patient Phase II trial of GDC-0449 in advanced BCC has been completed and data is expected from this study in 1H11 with potential regulatory submissions in 2011.