Health & Fitness
Health and Fitness
Health and Fitness
Fri, February 13, 2009
Thu, February 12, 2009 Curis Announces Genentech?s Initiation of Pivotal Phase II Trial of GDC-0449 in Advanced Basal Cell Carcinoma
CAMBRIDGE, Mass.--([ BUSINESS WIRE ])--Curis, Inc. (NASDAQ: CRIS), a drug development company seeking to develop next generation proprietary targeted medicines for cancer treatment, today announced that its collaborator Genentech treated the first patient in 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). Curis and Genentech had previously disclosed the expected trial initiation in separate January announcements. 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 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. More information about the trial can be found at ClinicalTrials.gov.
About the Curis-Genentech Collaboration
Under Curis' ongoing collaboration agreement with Genentech, Curis provided broad intellectual property rights relating to the Hedgehog pathway, including several classes of proprietary small molecule inhibitors. Through this collaboration, GDC-0449 was discovered by Genentech and was jointly validated by the parties through a series of preclinical studies. Genentech and Roche collaborate on the clinical development and commercialization of GDC-0449. Curis is eligible to receive cash payments upon successful achievement of certain clinical development and regulatory approval milestones and royalties upon commercialization of GDC-0449.
About Curis, Inc.
Curis is a drug development company that is committed to leveraging its innovative signaling pathway drug technologies to seek to create new medicines 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. For more information, visit Curis' website at [ www.curis.com ].
Cautionary Statement: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation statements regarding Curis' expectations that it will receive a $6 million cash payment from Genentech following initiation of this pivotal trial.The Company may usewords such as "believes", "expects", "anticipates", "plans", "seeks", "estimates", "will", "may" or similar expressions to identify these forward-looking statements.There are important factors that may cause actual results to be materially different from those indicated by such forward-looking statements.The Company faces risk factors identified in the Quarterly Report on Form 10-Q for the quarter ended September 30, 2008 and other filings that itperiodically makes with the Securities and Exchange Commission.
In addition, any forward-looking statements represent the Company's views only as of today and should not be relied upon as representing the views as of any subsequent date.Curis disclaims any intention or obligation to update any of the forward-looking statements after the date of this press release whether as a result of new information, future events or otherwise.
