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May 3rd, 2010
dBusiness News

Curis Completes Enrollment of CUDC-101 Phase I Clinical Trial

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- 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," 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."

About the Phase I Clinical Trial

The Phase I trial was designed as an open-label, dose escalation study of CUDC-101 in patients with advanced, refractory solid tumors. The primary objectives of the Phase I trial were to evaluate the safety and tolerability of escalating doses of CUDC-101 and to establish the MTD and dose limiting toxicities. Secondary objectives are to assess the pharmacokinetics, to evaluate pharmacodynamic biomarkers and to assess efficacy and ability of CUDC-101 to effectively inhibit HDAC, EGFR and Her2 in this patient population. The study was conducted at two clinical sites within the United States and enrolled 25 patients across several dose-escalating cohorts.

About CUDC-101

CUDC-101 is designed as a first-in-class therapeutic to simultaneously inhibit HDAC, EGFR and Her2. In preclinical studies, CUDC-101 demonstrated the potential to inhibit all three molecular targets resulting in the potent killing of a wide range of cancer cell lines that are representative of a variety of human cancer types, many of which have demonstrated resistance to various approved targeted agents.

Curis-generated data suggest that CUDC-101's mechanism of action involves the sensitization of cancer cells to EGFR and Her2 inhibition through HDAC inhibition. CUDC-101 simultaneously inhibits both EGFR and Her2 at the receptor level while inhibiting downstream HDAC activity within the cancer cells. Despite the existence of other multi-targeted inhibitors, CUDC-101 is unique in its choice of targets, which may enable a synergistic attack on multiple nodes or points in the overall cancer pathway network that are used by tumors to survive, grow, and invade surrounding tissue. Utilizing the same targeted strategy with other currently available drugs would require combining two or three separate agents, which often have mismatched pharmacokinetic and distribution properties and often display additive dose limiting toxicities. In contrast, CUDC-101, as a single small molecule, may have the potential to act in the same cancer cells at the same time with fewer toxic side effects and thus potentially represents an important advance in targeted agent cancer therapy.

About Curis, Inc.

Curis is a drug development company that is committed to leveraging its innovative signaling pathway drug technologies to seek to create new targeted small molecule drug candidates for cancer. In expanding its drug development efforts in the field of cancer through its proprietary targeted cancer programs, Curis is building upon its previous experiences in targeting signaling pathways for the development of next generation targeted cancer therapies. For more information, visit Curis' website at www.curis.com.

Curis Cautionary Statement: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation: the Company's plans for future clinical development of CUDC-101, specifically its plan to initiate a Phase Ib clinical study for patients with select tumor types and its plan to initiate a Phase I/II clinical trial in non-small cell lung cancer patients; the Company's expectation of the date on which final trial data will be presented; and the belief that Phase I CUDC-101 data may translate into clinical improvements when compared to currently approved and marketed drugs that inhibit EGFR and/or Her2. Forward-looking statements used in this press release may contain the words "believes", "expects", "anticipates", "plans", "seeks", "estimates", "will", "may" or similar expressions. These forward-looking statements are not guarantees of future performance and involve risks, uncertainties, assumptions and other important factors that may cause the actual results to be materially different from those indicated by such forward-looking statements including, among other things:

In addition, any forward-looking statements represent the views only as of today and should not be relied upon as representing Curis' views as of any subsequent date. Curis disclaims any intention or obligation to update any of the forward-looking statements after the date of this press release whether as a result of new information, future events or otherwise.