Curis Licensee Debiopharm Initiates Phase I Clinical Trial of Hsp90 Inhibitor Debio 0932

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:

  • Curis may experience adverse results, delays and/or failures in its internal drug development programs, including with respect to its Phase I clinical trial of CUDC-101, and with respect to its ongoing preclinical studies of its other targeted cancer programs.
  • Genentech and Roche and Debiopharm may experience adverse results, delays and/or failures in their respective development programs under collaboration with Curis. For example, Genentech may not be able to replicate in later trials any favorable outcomes from earlier trials of GDC-0449, and Debiopharm may not be able to successfully advance Debio 0932 into clinical trials as planned.
  • Curis may experience difficulties or delays in obtaining or maintaining required regulatory approvals for products under development both internally and through its collaborations.
  • Curis may not be able to obtain or maintain the intellectual property protection necessary for the development and commercialization of drug candidates based on its technologies.
  • Curis may not be able to obtain the substantial additional funding required to conduct research and development of its drug candidates.
  • Curis may experience unplanned cash requirements, and may not receive additional anticipated payments under its collaborations, any of which could shorten the estimated period in which Curis will have cash to fund its operations and which could also adversely affect Curis' estimated operating expenses for 2010 and beyond.
  • Curis faces risks relating to its ability to enter into and maintain planned collaborations for development candidates under its targeted cancer programs, its ability to maintain its current collaborations with Genentech and Debiopharm, and the risk that any such collaborators will not perform adequately.
  • Curis also faces other risk factors identified in its Annual Report on Form 10-K for the year ended December 31, 2009 and other filings that it periodically makes with the Securities and Exchange Commission.

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.



CONTACT:

Curis, Inc.
Michael P. Gray, 617-503-6632
Chief Financial and Chief Operating Officer
[email protected]

KEYWORDS:   United States  North America  Massachusetts

INDUSTRY KEYWORDS:   Health  Biotechnology  Clinical Trials  Genetics  Oncology  Pharmaceutical

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