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Curis Announces Dosing Of First Patient In Phase I Clinical Trial Of Oral Formulation Of CUDC-101

LEXINGTON, Mass., Oct. 2, 2012 (GLOBE NEWSWIRE) -- Curis, Inc. (Nasdaq:CRIS), a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that the first patient has been treated in a Phase I clinical study of an oral formulation of CUDC-101 in patients with advanced and refractory solid tumors. CUDC-101 is a first-in-class small molecule drug candidate that has been designed as an inhibitor of histone deacetylase (HDAC), epidermal growth factor receptor (EGFR) and epidermal growth factor receptor 2 (Her2).

"We are pleased to participate in this trial of an oral formulation of this promising drug candidate," commented Dr. Anthony Tolcher, M.D., FRCP (C), Director of Clinical Research at South Texas Accelerated Research Therapeutics (START) in San Antonio, Texas, where the first patient was treated. Dr. Tolcher was the principal investigator for the Phase I dose escalation study of the intravenous (IV) formulation of CUDC-101. "Preliminary data from prior Phase I clinical studies of the IV formulation of CUDC-101 are intriguing, with CUDC-101 having demonstrated a favorable safety profile as well as initial signs of clinical activity," said Dr. Tolcher.

"The initiation of this Phase I clinical trial of an oral formulation of CUDC-101 is an important milestone for Curis. A successful outcome in this Phase I clinical study could greatly expand the potential for CUDC-101 to be further studied in several cancers, including but not limited to non-small cell lung and gastric cancers, where single pathway targeted agents have demonstrated clinical efficacy," said Dan Passeri, Curis' President and Chief Executive Officer. "We believe that CUDC-101 has potential in a number of additional indications as well, and we also are currently conducting a Phase I dose escalation study of the intravenous (IV) formulation of CUDC-101 in patients with locally advanced head and neck cancers in combination with standard of care radiation therapy and cisplatin."

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