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Curis Announces Re-Initiation Of Patient Dosing In CUDC-427 Monotherapy Clinical Trial

LEXINGTON, Mass., June 5, 2014 (GLOBE NEWSWIRE) -- Curis, Inc. (Nasdaq:CRIS), an oncology-focused biotechnology company developing novel drug candidates for the treatment of human cancers, today announced that it has re-initiated dosing in the single-agent clinical trial of CUDC-427 in patients with advanced and/or refractory solid tumors or lymphomas. CUDC-427 is a novel, oral small molecule that is designed to promote cancer cell death by antagonizing inhibitor of apoptosis (IAP) proteins that support survival of cancer cells.

The primary objective of the monotherapy study under the amended protocol is to determine the safety and recommended Phase 2 dose for CUDC-427 when administered orally once daily for two weeks, followed by a one week rest period in 21-day cycles until disease progression or study discontinuation. The study is expected to enroll patients in consecutive cohorts at dose levels of 100 to 300 mg per day. In addition to safety and tolerability measures, the amended protocol is designed to enroll patients in an expansion cohort, which is planned to be limited to patients with ovarian or certain hematologic cancers, including mucosa-associated lymphoid tissue (MALT) lymphoma.

"We are pleased that patients can once again receive CUDC-427 and are looking forward to further investigating this drug candidate's potential as a single agent," said Anthony W. Tolcher, M.D., FRCP, Director of Clinical Research at South Texas Accelerated Research Therapeutics (START). "We will continue to analyze specific genetic alterations and molecular signatures that may render certain patients' cancers more susceptible to CUDC-427's effects."

"We are pleased to have re-opened enrollment on the CUDC-427 monotherapy trial at START and Sarah Cannon Research Institute with risk mitigation measures designed to ensure patient safety," said Ali Fattaey, Ph.D., President and Chief Executive Officer of Curis. "We continue to believe in CUDC-427's potential as an anti-cancer agent either as a single agent or in combination settings in select cancer types."

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