Genentech Initiates Ovarian Cancer Trial

Genentech, Inc. will initiate a Phase II trial of GDC-0449, an orally administered small molecule Hedgehog antagonist, as a maintenance therapy for ovarian cancer patients in second or third complete remission. Genentech is developing the drug in collaboration with Curis, Inc. and will be the sponsor of this study.
   
GDC-0449 will be evaluated in approximately 100 patients in a randomized, placebo-controlled, double-blind, multi-center Phase II trial. Patients will be randomized to receive either GDC-0449 or a placebo comparator and will be separated based on whether their cancer is in a second or third complete remission. The primary endpoint of the trial is progression-free survival, and secondary outcome measures include overall survival, the amount of Hedgehog protein expression in archival tissue and tracking of adverse events.    
   
“We believe that the dysregulation of developmental pathways such as Hedgehog may play a role in the formation or recurrence of cancer. Therefore, we are hopeful that a Hedgehog inhibitor, such as GDC-0449, may be a useful therapeutic tool in preventing cancer from returning in these ovarian cancer patients and may prove useful as a maintenance therapy,” said Curis president and chief executive officer Dan Passeri. “GDC-0449 is currently in Phase II testing in first-line metastatic colorectal cancer and Genentech has indicated that it expects to initiate an additional Phase II clinical trial in advanced basal cell carcinoma in the second half of 2008.”