Curis’ Cancer Candidate Disappoints – Analyst Blog

Recently, Curis Inc. (CRIS) announced that its cancer candidate GDC-0449 did not meet its primary endpoint in a mid-stage study. The study evaluated GDC-0449 in combination with Roche’s (RHHBY) Avastin (bevacizumab) and chemotherapy as a first-line therapy in patients suffering from metastatic colorectal cancer.

 

The randomized, placebo-controlled, double-blind mid-stage study was conducted by Genentech, the wholly owned subsidiary of Roche, which oversees the development of GDC-0449 courtesy a licensing agreement with Curis. The trial, initiated in May 2008, failed to prolong the time of disease progression or death in the subjects treated with GDC-0449 in addition to Avastin and chemotherapy when compared to those treated only with Avastin.

 

GDC-0449, an inhibitor of the hedgehog pathway, which is believed to encourage the growth and survival of certain cancer cells, is being evaluated in other cancer forms. Enrolment has been completed in another mid-stage study in patients suffering from advanced basal cell carcinoma (BCC).

 

GDC-0449 was well tolerated in the study. The most frequent adverse events were muscle spasms, altered taste, weight loss and hyponatremia. Data from this pivotal mid-stage study is expected in 2011. Furthermore, Roche intends to initiate a mid-stage study in operable basal cell carcinoma patients during the second half of 2010. The successful development and commercialization of GDC-0449 for these indications could convert a small company like Curis into a big player in the biotechnology space.

 

Based in Cambridge, Massachusetts, Curis is a drug development company focusing on cancer, neurological and dermatological disease indications, with technologies that make use of regulatory pathways to control repair and regeneration. Curis’ product development involves the use of small molecules or proteins to modulate these pathways.