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news.Curis, a drug development company, has 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.
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Under the companies’ collaboration agreement, Curis will receive a $6 million cash payment from Genentech following initiation of this pivotal trial.
Genentech expects to evaluate GDC-0449 in approximately 100 patients with metastatic or locally advanced basal cell carcinoma (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.
Dan Passeri, president and CEO of Curis, said: 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.
We are pleased that our collaborator Genentech has worked with the FDA on the study design for this pivotal Phase II trial in advanced BCC. 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 new drug application submission by Genentech. We look forward to providing further updates on the progress of this trial in the future.