Curis, Inc, a drug development company seeking to develop next generation proprietary targeted medicines for cancer treatment, announced that its collaborator Genentech has indicated that it expects to initiate in January 2009 a pivotal phase-II clinical trial of GDC-0449, an orally-administered small molecule Hedgehog Pathway Inhibitor, as a single-agent therapy for patients with metastatic or locally advanced basal cell carcinoma (BCC). Under the companies' collaboration agreement, Curis will receive a $6 million cash payment from Genentech following initiation of this pivotal trial.

"The expected near-term initiation of this pivotal trial represents a significant development milestone for GDC-0449 in metastatic and locally advanced BCC and, we believe, builds upon the strong phase-I safety and efficacy data demonstrated by the drug, which showed clinical benefit in a substantial proportion of advanced BCC patients," said Curis president and CEO Dan Passeri. "We are pleased that our collaborator Genentech has worked with the FDA on the study design for this pivotal phase-II trial in advanced basal cell carcinoma. There is currently no standard of care for patients with these types of BCC and this pivotal trial is designed so that its data, if positive, may serve as the basis for NDA submission by Genentech. We look forward to providing further updates on the progress of this trial in the future."

Genentech expects to evaluate GDC-0449 in approximately 100 patients with metastatic or locally advanced BCC in a global single-arm, two-cohort clinical trial. One cohort includes all patients with histologically-confirmed, RECIST measurable metastatic BCC. The second cohort includes histologically-confirmed locally advanced BCC that is considered inoperable by the treating physician. All patients will receive a daily oral dose of GDC-0449. Trial details are expected to be posted at ClinicalTrials.gov prior to first patient enrolled in this trial.

"In addition to the near-term advancement of this promising clinical candidate, this pivotal trial initiation has added significance because it provides Curis with $6 million in non-dilutive cash that, when added to our existing capital, is sufficient to fund our currently-planned operations into mid-2010," said Curis chief operating and chief financial officer Mike Gray. "This additional capital allows us to continue to execute our strategy of seeking to enter into collaborations around CUDC-305, our Hsp90 inhibitor, and CUDC-101, our first-in-class HDAC/EGFR/Her2 inhibitor, which we expect will both provide value to our shareholders while also reducing the financial risk of developing our assets independently."

Under the ongoing collaboration agreement between Genentech and Curis, GDC-0449 was discovered by Genentech and was jointly validated through a series of preclinical studies.

Curis is a drug development company that is committed to leveraging its innovative signalling pathway drug technologies to seek to create new medicines for cancer.