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Curis Reports CUDC-907 Preliminary Data From The Ongoing Phase 1 Trial At ASH 2013 Annual Meeting

CUDC-907 (HDAC and PI3K inhibitor) demonstrates preliminary evidence of clinical activity

Dose escalation ongoing with intermittent oral administration schedule in patients with relapsed/refractory lymphoma or multiple myeloma

LEXINGTON, Mass., Dec. 9, 2013 (GLOBE NEWSWIRE) -- Curis, Inc. (Nasdaq:CRIS), an oncology-focused company developing novel, targeted drug candidates for the treatment of human cancers, today announced preliminary first-in-human results from its ongoing Phase 1 trial of CUDC-907. These data will be presented today at the 55 th Annual Meeting of the American Society of Hematology (ASH) in New Orleans, LA. Intermittent oral dosing of CUDC-907 appears to be better tolerated than continuous daily dosing (QD), which demonstrated preliminary evidence of anti-tumor activity with a partial response (PR) observed in 1 patient. In addition, stable disease (SD) has been observed in 7 of 11 response-evaluable patients.  CUDC-907 is an oral, dual inhibitor of histone deacetylase (HDAC) and phosphoinositide 3-kinase (PI3K) enzymes that is currently under investigation in a Phase 1 trial in patients with relapsed/refractory lymphoma or multiple myeloma (MM).

"We are encouraged by the preliminary results of our ongoing Phase 1 study and will further explore clinical activity signals when administering CUDC-907 on intermittent dosing schedules," said Dr. Ali Fattaey, Ph.D., Curis' President and Chief Operating Officer. "After establishing a safe and tolerable dose range for the intermittent schedules, we expect to initiate the expansion phase of this study followed by mid-stage clinical trials in one or more hematologic malignancies in the second half of 2014."

"CUDC-907's unique mechanism of action and its promising early clinical profile support further investigation in patients with aggressive lymphomas or multiple myeloma," said Dr. Jaye Viner, M.D., M.P.H, Curis' Executive Vice President and Chief Medical Officer.

The dose escalation study was designed to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose, as well as preliminary anti-cancer activity of single agent       CUDC-907 in patients with relapsed/refractory lymphoma or MM. At the time of data cut-off for the ASH presentation, 13 patients had received daily (QD) or twice weekly (BIW) regimens at doses of 30 mg QD (n=7), 60 mg QD (n=3) or 60 mg BIW (n=3). More recently, investigators began enrolling patients in a third dosing schedule in which CUDC-907 is administered thrice weekly (TIW).

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