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Curis Announces Initiation Of A Clinical Trial Of CUDC-427 In Advanced Malignancies

LEXINGTON, Mass., July 25, 2013 (GLOBE NEWSWIRE) -- Curis, Inc. (Nasdaq:CRIS), an oncology-focused drug development company seeking to develop novel drug candidates for the treatment of human cancers, today announced dosing of the first patient in a Phase 1 dose-escalation study of CUDC-427 that is being conducted using a continuous, twice-daily oral dosing regimen in patients with advanced and refractory solid tumors or lymphoma. This trial builds on the single agent clinical results observed in the initial Phase 1 trial of CUDC-427, which were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2013. The primary objectives of the current study are to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose of CUDC-427 using a more frequent dosing regimen. Additionally, the trial is designed to enroll up to 12 patients in an expansion cohort, which is expected to primarily include patients with ovarian and fallopian tube cancers. CUDC-427 is an oral, small molecule Smac mimetic drug candidate that selectively antagonizes inhibitor of apoptosis (IAP) proteins in cancer cells, resulting in induction of programmed cell death.

"The encouraging results of the previous Phase 1 trial for CUDC-427, including complete responses in a patient with ovarian cancer and a mucosa-associated lymphoid tissue (MALT) lymphoma patient, strongly support further evaluation of this agent in patients with certain genetic alterations," said Anthony W. Tolcher, M.D., FRCP, Director of Clinical Research at South Texas Accelerated Research Therapeutics (START). "In addition to this trial, we are also conducting additional preclinical studies to further explore potential mechanisms of CUDC-427's activity using ovarian and breast cancer patient-derived xenograft models. The preclinical data in combination with data from the recently initiated study are expected to provide strong rationale for further development of CUDC-427 as a single agent in select malignancies."

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