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Curis Achieves Phase I Milestone Under Hsp90 Collaboration with Debiopharm

^{Published on 2010-07-06 19:20:23 - Market Wire}
 

CAMBRIDGE, Mass.--([ BUSINESS WIRE ])--Curis, Inc. (NASDAQ: CRIS) announced today that its licensee Debiopharm S.A. (aDebiopharma) has treated the fifth patient in its ongoing Phase I clinical trial for small molecule heat shock protein 90 (Hsp90) inhibitor Debio 0932, formerly called CUDC-305. Under the terms of the August 2009 license agreement between Curis and Debiopharm, Curis will receive a $3 million milestone payment from Debiopharm for the achievement of this development objective.

"Debiopharma™s achievement of this important development milestone has brought the total consideration that we have earned to date under this collaboration to $13 million."

aOur relationship with Debiopharm has provided Curis with an important source of capital over the last several months,a said Dan Passeri, Curisa™ President and Chief Executive. aDebiopharma™s achievement of this important development milestone has brought the total consideration that we have earned to date under this collaboration to $13 million.a

About the Phase I Clinical Trial

Debiopharm recently initiated a Phase I clinical trial that 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 targeted small molecule drug candidates for cancer. Curis is building upon its previous experiences in targeting signaling pathways, including in the Hedgehog pathway, in its effort to develop proprietary targeted cancer programs. 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 statements regarding: its belief that it will receive the $3 million payment that Debiopharm is contractually obligated to pay for the achievement of this development objective.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:

• Genentech and Roche may experience adverse results, delays and/or failures in their development program under collaboration with Curis. For example, Genentech may not be able to replicate in later trials any favorable safety and efficacy data from earlier trials of GDC-0449, or may otherwise fail to meet applicable regulatory standards for approval of GDC-0449.
• Curisa™ collaborator Debiopharm may experience adverse results, delays and/or failures in its development program under collaboration with Curis. For example, Debiopharm may not be able to successfully advance Debio 0932 through its ongoing Phase I clinical trial as planned.
• 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.
• 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/Roche and Debiopharm, and the risk that any such collaborators will not perform adequately or may terminate such collaborations on short notice and/or for circumstances outside of our control.
• Curis also faces other risk factors identified in its Quarterly Report on Form 10-Q for the quarter ended March 31, 2010 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.