Curis Achieves Phase I Milestone Under Hsp90 Collaboration With Debiopharm

Main Category: Cancer / Oncology
Also Included In: Lymphoma / Leukemia / Myeloma;  Clinical Trials / Drug Trials
Article Date: 08 Jul 2010 - 0:00 PDT

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Curis, Inc. (NASDAQ: CRIS) announced that its licensee Debiopharm S.A. ("Debiopharm") 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.

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

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.

Source:
Curis, Inc.

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