Curis completes enrollment in Phase I clinical trial of CUDC-101 HDAC, EGFR and HER2 inhibitor

May 3 2010

Curis, Inc. (NASDAQ: CRIS), a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that it has successfully completed enrollment and treatment of the last patient in its Phase I clinical trial of CUDC-101, Curis' first-in-class HDAC, EGFR and HER2 inhibitor.

“The completion of enrollment and the ensuing establishment of the maximum tolerated dose in this trial are important steps forward, both for the development of CUDC-101 and also for Curis' clinical development efforts as we continue to build a portfolio of partnered and proprietary targeted small molecules for cancer indications”

"The completion of enrollment and the ensuing establishment of the maximum tolerated dose in this trial are important steps forward, both for the development of CUDC-101 and also for Curis' clinical development efforts as we continue to build a portfolio of partnered and proprietary targeted small molecules for cancer indications," said Dan Passeri, Curis' President and Chief Executive Officer. "The ability to administer CUDC-101 at biologically active concentrations with what appears to be a favorable safety profile opens the way for the future clinical development of CUDC-101 and is an important step in validating Curis' proprietary platform of targeted small molecules capable of simultaneously inhibiting multiple nodes within a single cell."

Mr. Passeri continued, "Looking ahead, we plan to initiate a Phase Ib clinical study with CUDC-101 with the intent to enroll additional patients at the established maximum tolerated dose (MTD) of 275 mg/m² at various dosing schedules and in select tumor types including gastric, head and neck, breast and liver cancers, to seek additional signals of activity and to help guide future clinical studies. We also plan to initiate a Phase I/II clinical trial of CUDC-101 in non-small cell lung cancer patients in the second half of 2010 and are currently working to formalize the design of this clinical study."

Curis is continuing to audit study data, while completing pharmacokinetic and biomarker analyses, and the Company expects that the study's principal investigator, Anthony W. Tolcher, M.D., the Director of Clinical Research at South Texas Accelerated Research Therapeutics (START), will present final trial data at the 22nd EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, which is being held November 16-19, 2010 in Berlin, Germany.

"We are very pleased with the preliminary evidence of clinical anti-tumor activity seen with CUDC-101 in this phase I population," stated Dr. Tolcher. "Based on its mechanism of action, CUDC-101 may represent a significant advancement over existing drugs that inhibit EGFR and/or Her2 and has the potential to improve treatment and response rates for a large number of cancer patients with drug-resistant solid tumors."

SOURCE Curis, Inc.