Curis Inc, a drug development company announced its collaborator Genentech has initiated a phase II clinical trial of GDC-0449, an orally-administered small molecule Hedgehog antagonist, in metastatic colorectal cancer. As a result, Genentech will make a $3 million cash payment to Curis under the companies' June 2003 collaboration agreement.

"We are hopeful that GDC-0449 may one day provide an additional option to the existing standard of care for metastatic colorectal cancer patients," said Curis President and CEO Dan Passeri. "In addition, Genentech previously has announced that it plans to initiate two additional phase II clinical trials of GDC-0449 in the second half of 2008, including trials in advanced basal cell carcinoma, where patient responses have been observed in the ongoing phase I study, and in an undisclosed advanced solid tumour of epithelial origin. We look forward to providing further updates on these programs in the future".

GDC-0449 will be evaluated in approximately 150 patients with metastatic colorectal cancer in combination with the current standard of care in a randomized, placebo-controlled, double-blind phase II trial. Patients will receive either Folfox or Folfiri chemotherapy in combination with bevacizumab and will be randomized to receive GDC-0449 or placebo. They will be stratified based on the chemotherapy regimen chosen and whether or not Response Evaluation Criteria in Solid Tumours (RECIST) measurable disease is present at baseline.

RECIST provides standard parameters to be used when documenting patient response for solid tumours. The primary objective of the trial is progression-free survival from randomization to disease progression or death. Secondary outcome measures include the measurement of Hedgehog protein expression in archival tissue and tracking of adverse events.

Colorectal cancer remains a major unmet medical need, with the American Cancer Society estimating that approximately 150,000 new cases and 50,000 deaths will be attributable to this cancer in the United States in 2008. Colorectal cancer is the second leading cause of cancer death in the United States and the third most frequently diagnosed cancer.

Should GDC-0449 advance into subsequent stages of clinical testing and regulatory approval, Curis would be eligible to receive additional cash milestone payments from Genentech. In addition, in the event the drug candidate is successfully commercialized, Curis would be eligible to receive royalties on product sales.

Curis is a drug development company that is committed to leveraging its innovative signaling pathway drug technologies to seek to create new medicines, primarily for cancer. In expanding its drug development efforts in the field of cancer through its targeted cancer drug development platform, Curis is building upon its previous experiences in targeting signaling pathways for the development of next generation targeted cancer therapies.