Health & Fitness
Health and Fitness
Health and Fitness
Mon, February 9, 2009 Curis Announces Collaborative Agreement between Genentech and National Cancer Institute on GDC-0449
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 Curis' collaborator Genentech, Inc. and the National Cancer Institute's (NCI) Division of Cancer Treatment and Diagnosis (DCTD) are planning to enter into a Cooperative Research and Development Agreement (CRADA) which will allow the NCI to explore GDC-0449, an orally-administered small molecule Hedgehog Pathway Inhibitor, in a number of cancer indications.
"We are very pleased that Genentech is planning to enter into this CRADA with NCI to advance the development efforts of GDC-0449. Genentech has a broad GDC-0449 Phase II clinical program, including trials in colorectal cancer, advanced ovarian cancer and advanced basal cell carcinoma, and we believe that this agreement with the NCI may allow for GDC-0449 to be tested in many additional cancer indications," said Curis President and CEO Dan Passeri. "We believe that such trials can have a significant impact on the overall development of GDC-0449, since they provide an opportunity to generate additional data in tumor types not already under investigation by Genentech. We look forward to the possible future initiation of clinical trials under this NCI collaboration, which we hope will build on the exciting biological activity previously reported in advanced basal cell carcinoma."
A DCTD-sponsored Phase I clinical trial is expected to be initiated to evaluate dose and safety of GDC-0449 in pediatric patients with medulloblastoma. Medulloblastoma is a rare but highly malignant brain tumor that occurs most often in children. In addition to this Phase I medulloblastoma clinical trial, the NCI plans to sponsor additional clinical trials under this CRADA, including clinical trials in patients with small cell lung and pancreatic cancers, among others. Trial details of the medulloblastoma Phase I trial are available on [ clinicaltrials.gov ]. Other trial information is expected to be posted to [ clinicaltrials.gov ] as the respective trial nears initiation.
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. Curis is not entitled to receive additional cash payments on the initiation of clinical trials conducted under this collaboration with NCI.
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 the Company's expectation that additional clinical studies will be conducted under the CRADA and that data resulting from such trials will be valuable to the development of GDC-0449.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 including, among other things, risks relating to: the potential for adverse results, delays and/or failures in the Company's targeted cancer drug development program, including without limitation unplanned delays and/or failures in its clinical trial of CUDC-101 and its ongoing preclinical studies of CUDC-305; the success of the Company's collaboration with Genentech, including the risks that Genentech may experience adverse results, delays and/or failures in the Hedgehog Pathway Inhibitor program currently under clinical development and that the Company may have no control over, or foreknowledge of, the progress of this program; difficulties or delays in obtaining or maintaining required regulatory approvals for products under development both internally and through the Genentech collaboration; the Company's ability to obtain or maintain necessary intellectual property protection; adverse changes in the Company's ability to successfully execute its business plan, includingthe Company's ability to obtain the substantial additional funding required for such execution; unplanned cash requirements and expenditures which, among other things, could shorten the estimated period in which the Company will have cash to fund its operations and which could also adversely affect the Company's estimated operating expenses for 2008 and beyond; risks relating to the Company's ability to enter into and maintain planned collaborations and maintain its current collaborations with Genentech; and competitive pressures.The Company also faces other 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.
