Curis, Inc. (NASDAQ: CRIS), a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that its collaborator Genentech, a member of the Roche Group, has initiated a Phase II clinical trial of GDC-0449, an orally-administered small molecule Hedgehog Pathway Inhibitor, as a single-agent therapy for patients with operable basal cell carcinoma (BCC).
“We are very pleased that Genentech has initiated a Phase II clinical trial in operable BCC as we believe it demonstrates Genentech's ongoing commitment and diligence in exploring GDC-0449 in BCC”
"We are very pleased that Genentech has initiated a Phase II clinical trial in operable BCC as we believe it demonstrates Genentech's ongoing commitment and diligence in exploring GDC-0449 in BCC," said Dan Passeri, Curis President and Chief Executive Officer. "In addition, Genentech and Roche continue to work with clinical investigators to evaluate GDC-0449 in other diseases with Hedgehog-pathway mutations such as medulloblastoma, a childhood brain cancer (in studies sponsored by the National Cancer Institute) and in BCCs in basal cell nevus (Gorlin) syndrome, a rare genetic disorder in which patients typically develop multiple BCCs over their lifetime."
In addition to conducting a trial of GDC-0449 in operable BCC, Genentech and Roche are developing GDC-0449 in advanced BCC, a severe form of the disease that includes cutaneous BCCs considered inoperable by the treating physician and BCCs that have metastasized to other tissues and organs. Genentech previously reported compelling proof-of-concept data from a Phase I clinical trial of GDC-0449 in patients suffering from advanced BCC, including the observation of a 55% response rate in 33 advanced BCC patients. In the Phase I study of GDC-0449, the most frequent adverse events included muscle spasms, altered taste, weight loss and hyponatremia. Genentech and Roche have completed enrollment in a 100-patient pivotal Phase II clinical trial of GDC-0449 in advanced BCC, and have indicated that they expect data from this study in the first half of 2011 and, pending successful results, that they could also file regulatory approval submissions in 2011.
Under a collaborative relationship with the NCI, GDC-0449 is also currently being tested in other cancers through several NCI-sponsored trials, including in pancreatic, small cell lung cancer, esophageal, stomach, breast and prostate cancers, among others. Details for all GDC-0449 clinical trials are available at ClinicalTrials.gov.
Genentech has also completed further analyses of results from its recently-completed Phase II clinical trial of GDC-0449 in advanced ovarian cancer. The median time to disease progression in the Phase II study was 7.5 months for patients who received GDC-0449 compared to 5.8 months for patients who received placebo.