Positive Results in Genentech Ph II Clinical Trial of GDC-0449 in Advanced Basal Cell Carcinoma

2011-03-21 15:08:47

Curis, Inc. (NASDAQ: CRIS), a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced a positive outcome from a pivotal Phase II clinical trial conducted by Roche and Genentech, Curis' collaborator and a wholly owned member of the Roche Group, of GDC-0449, a first-in-class hedgehog pathway inhibitor, in patients with advanced basal cell carcinoma (BCC). Genentech informed Curis that the study met its primary endpoint of achieving a target overall response rate, showing that GDC-0449 shrank advanced BCC 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. Roche has indicated that it anticipates making at least one regulatory submission in 2011 to seek approval to commercialize GDC-0449.

Hedgehog was initially identified as a developmentally related gene in drosophila at the London Research Institute (Phil Ingham in collaboration with Harvard scientists). CRT subsequently licensed Hedgehog IP to Curis in 1995.

View the Curis press announcement for more information.

Notes to editors