CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Curis, Inc. (NASDAQ: CRIS) announced today that its licensee Debiopharm S.A. (“Debiopharm”) has treated the first patient in a Phase I clinical trial for small molecule heat shock protein 90 (Hsp90) inhibitor Debio 0932, formerly called CUDC-305.
“We continue to be impressed by the performance of our partner Debiopharm in advancing Debio 0932 rapidly into Phase I clinical testing,” said Dan Passeri, Curis’ President and Chief Executive. “We look forward to the continued enrollment of this trial and the further exploration of the safety and tolerability of Debio 0932 in patients.”
Under the terms of the August 2009 license agreement between Curis and Debiopharm, Curis will receive a $3 million milestone payment from Debiopharm upon Debiopharm’s treatment of the fifth patient in this Phase I clinical trial.
About the Phase I Clinical Trial
The Phase I clinical trial is designed to evaluate the maximum tolerated dose and safety of Debio 0932. The first part of the study (Phase Ia) is an open-label, multi-center dose escalation trial evaluating the safety and tolerability of escalating multiple dose levels of Debio 0932 as a single agent given orally in patients suffering from advanced solid tumors or lymphoma.
The dose-limiting toxicities, maximum tolerated dose, and pharmacokinetic parameters will be determined using both every other day and daily administration regimens, to guide the recommended Phase Ib dose and schedule. The secondary objective will be to assess whether changes in pharmacodynamic biomarkers indicative of Hsp90 inhibition by Debio 0932 can be reliably measured in patient samples.
The objective of the Phase Ib study, an expansion cohort of certain solid tumor and/or lymphoma patients, will be to further assess the safety profile, pharmacokinetics and pharmacodynamics of Debio 0932 at a potential Phase II dose level, and to make a preliminary assessment of anti-tumor activity in patients with advanced solid tumors.
Debiopharm has indicated that it expects to treat up to 80 patients in the Phase Ia portion of the trial, and once the recommended dose for each schedule is reached, Debiopharm may treat up to 40 additional patients at the chosen dose and schedule as part of the Phase Ib expansion phase.
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 medicines for cancer indications. In expanding its drug development efforts in the field of cancer through its targeted cancer drug development platform, Curis is building upon its previous experiences in targeting signaling pathways, including in the Hedgehog signaling pathway, 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 belief that it will receive the $3 million payment upon Debiopharm’s treatment of the fifth patient in this Phase I clinical trial and its belief that the Phase I trial design will yield meaningful data for the future development of Debio 0932. 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.
Michael P. Gray, 617-503-6632
Chief Financial and Chief Operating Officer
KEYWORDS: United States North America Massachusetts
INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Genetics Oncology Pharmaceutical