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Curis Announces CUDC-427 (GDC-0917) Phase I Clinical Data Presented At ASCO 2013 Annual Meeting

LEXINGTON, Mass., June 3, 2013 (GLOBE NEWSWIRE) -- Curis, Inc. (Nasdaq:CRIS), an oncology-focused company seeking to develop next generation targeted drug candidates for cancer treatment, today announced that Phase I data were presented during an oral session at the American Society of Clinical Oncology's (ASCO) 2013 annual meeting on the Company's clinical candidate CUDC-427 (previously GDC-0917), in patients with refractory cancers. In addition to demonstrating a favorable safety and pharmacokinetic profile, single agent CUDC-427 also showed preliminary signals of clinical activity; including unconfirmed complete responses in 2 patients. CUDC-427 is an oral, small molecule Smac mimetic drug candidate that triggers programmed cell death by selectively antagonizing inhibitor of apoptosis, or IAP, proteins in cancer cells. CUDC-427 was exclusively licensed from Genentech in November 2012, and the results reported were from the Phase I study conducted by Genentech. 

"We are pleased with the Phase I study results, which demonstrate CUDC-427's favorable safety, pharmacokinetic and pharmacodynamic profile in patients with advanced malignancies, while also providing clinical benefit as a single agent in certain cancer patients," said Ali Fattaey, Curis President and Chief Operating Officer. "We expect to initiate a mid-stage clinical trial to further assess the efficacy of CUDC-427 in combination with standard chemotherapy in patients with advanced breast cancer in the third quarter of 2013. We are also starting additional studies to further examine single agent activity of CUDC-427 in select cancer patients based on the Phase I clinical observations, which are consistent with CUDC-427's molecular targets and mechanism of action."

"The preclinical and encouraging Phase I study results suggest development strategies that include specific drug combination approaches to treat subsets of cancer patients, as well as novel single agent treatment strategies for specific patient populations based on the underlying nature of the patient's disease," said Anthony W. Tolcher, M.D., FRCP, Director of Clinical Research at South Texas Accelerated Research Therapeutics (START). "For example, we observed unconfirmed complete responses in a patient with ovarian cancer and a MALT lymphoma patient in this study. We are evaluating the correlation between these responses with the underlying genetic profile of the patients' cancer and conducting additional preclinical studies to further explore potential mechanisms of the drug candidate's activity. These analyses will be the basis for further testing of CUDC-427 as a single agent to treat selected cancer patients."

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