Initiation of Phase II trial of GDC-0449 in ovarian cancer triggers payment.

Genentech initiated a Phase II trial of GDC-0449, an orally administered small molecule Hedgehog pathway inhibitor, as a maintenance therapy for ovarian cancer patients in second or third complete remission. As a result, Curis will receive a $3 million cash payment from Genentech.

GDC-0449 was discovered by Genentech and was jointly validated by the two companies through a series of preclinical studies. Genentech and Roche collaborated on the clinical development and commercialization of GDC-0449. Curis is eligible to receive cash payments upon successful achievement of certain clinical development and regulatory approval milestones and royalties upon commercialization of GDC-0449.

GDC-0449 will be evaluated in approximately 100 patients with ovarian cancer in second or third complete remission. Patients will be randomized in a 1:1 ratio to receive either GDC-0449 or a placebo comparator and will be stratified based on whether their cancer is in a second or third complete remission. The primary endpoint of the trial is progression-free survival. Secondary outcome measures include overall survival, measurement of Hedgehog ligand expression in archival tissue, and number and attribution of adverse events.

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