Curis shares plummet as 'Hedgehog' drug being developed with Roche fails in colorectal cancer trial

US drug developer Curis saw its shares plunge 48% to $1.69 yesterday, on news of negative top-line results from a Phase II trial of GDC-0449 plus Avastin (bevacizumab) compared to FOLFOX or FOLFIRI chemotherapy in first-line treatment of metastatic colorectal cancer. GDC-0449, a so-called Hedgehog-pathway inhibitor and Curis' lead drug candidate, is being developed in partnership with Swiss drug major Roche and its subsidiary Genentech.

Roche has informed Curis that the trial did not meet its primary endpoint of extending the time from randomization to disease progression or death in study patients who received GDC-0449 in addition to the current standard of care of bevacizumab and chemotherapy when compared to those patients who received only the current standard-of-care treatment. GDC-0449 is being developed by Roche and Genentech under a collaboration agreement between Curis and Genentech. It is expected that data from the Phase II study will be submitted for presentation at a future medical meeting.

"Despite these disappointing results in metastatic colorectal cancer, we remain encouraged that Genentech and Roche's clinical development of GDC-0449 in other cancers continues to make good progress," said Dan Passeri, Curis' president and chief executive.