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Curis Announces Genentech's Initiation of Phase II Clinical Trial in Advanced Ovarian Cancer with Hedgehog Pathway Inhibitor

- Trial Tests GDC-0449 as a Single Agent in Maintenance Therapy -

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dec. 8, 2008--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 has initiated a Phase II clinical trial of GDC-0449, an orally-administered small molecule Hedgehog pathway inhibitor, as a maintenance therapy for ovarian cancer patients in second or third complete remission. Under the companies' collaboration agreement, Curis will receive a $3 million cash payment from Genentech.

"There is a significant unmet treatment need for patients with relapsed ovarian cancer," said Curis President and CEO Dan Passeri. "While many advanced ovarian cancer patients initially experience clinical remission with current therapies, the disease recurs for most patients. Genentech designed this Phase II trial to investigate if GDC-0449 may help delay tumor re-growth following clinical remission of cancer after second-line chemotherapy treatment for recurrent disease. We are hopeful that GDC-0449 may one day provide an additional therapy to existing treatment options for ovarian cancer patients, and we look forward to providing further updates on this program in the future."

GDC-0449 will be evaluated in approximately 100 patients with ovarian cancer in second or third complete remission in a randomized, placebo-controlled, double-blind, multi-center Phase II trial. Patients will be randomized in a 1:1 ratio to receive either GDC-0449 or a placebo comparator and will be stratified based on whether their cancer is in a second or third complete remission. The primary endpoint of the trial is progression-free survival. Secondary outcome measures include overall survival, measurement of Hedgehog ligand expression in archival tissue and number and attribution of adverse events. Trial details are posted at ClinicalTrials.gov.

According to the American Cancer Society, ovarian cancer is the eighth most common cancer, excluding skin cancer, with estimates of over 22,000 new cases in the United States in 2007 with over 15,000 deaths attributable to this cancer.

Under the ongoing collaboration agreement between Genentech and Curis, GDC-0449 was discovered by Genentech and was jointly validated 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 the Company's hopes regarding the potential clinical benefits of GDC-0449 in advanced ovarian cancer. The Company may use words 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, including the 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 it periodically 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.

CONTACT:
Curis, Inc. Michael P. Gray
617-503-6632
Chief Financial Officer
mgray@curis.com

Source: Curis, Inc.

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