Curis, Inc. (NASDAQ:CRIS), a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today reported its financial results for the third quarter ended September 30, 2011.
"The third quarter marked an important period for Curis, due to our collaborator Genentech's NDA submission to the FDA seeking sales and marketing approval for vismodegib (GDC-0449, RG3616) in the U.S. to treat people with advanced basal cell carcinoma (BCC),” said Dan Passeri, Curis President and Chief Executive Officer. “We believe that this first-in-class molecule has the potential to provide an important new treatment option for patients with advanced BCC. Importantly, Curis is eligible to receive an $8 million milestone payment from Genentech upon FDA acceptance of this submission and, if the drug subsequently receives FDA approval, we will receive an additional milestone payment as well as royalties on any future sales. We also continue to anticipate that Roche will file an MAA submission with the EMA for regulatory approval of vismodegib in the European Union, the timing of which is subject to ongoing discussions between Roche and European health authorities.”
Mr. Passeri continued, "In addition, we continued to advance our pipeline, beginning with our Phase I dose escalation, combination trial of our first-in-class EGFR, Her2 and HDAC inhibitor CUDC-101 in head and neck cancer patients. We also completed enrollment in our Phase I expansion study of CUDC-101 in several cancer types and are very pleased with the results observed to-date, which include observations of long-term stable disease across several cancer types, data that demonstrate that we are hitting our intended molecular targets and a favorable safety profile, consistent with that observed in our Phase I dose escalation study. Looking ahead, we expect to initiate a Phase I clinical trial for an oral formulation of CUDC-101 and also a Phase I trial for new development candidate CUDC-907, a PI3K and HDAC inhibitor, in the first half of 2012, and Debiopharm, our licensee for our Hsp90 inhibitor Debio 0932, has indicated that it plans to initiate Phase Ib studies of Debio 0932 in the near term.”