From Curis' website I would think they have treated about 80 patients or will shortly:
Debio 0932
Licensed to Debiopharm SA
Debio 0932 is a small molecule inhibitor of Heat Shock Protein 90 (Hsp90). Curis licensee Debiopharm is finalizing the Phase I dose escalation study of this molecule and expects to initiate a Phase Ib trial in early 2012 and a Phase II study during the second half of 2012.
Debiopharm has indicated that it expects to present data from the Phase I dose escalation study at a medical conference in 2012.
About the Debio 0932 Phase I Clinical Trial
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 by using both every other day and daily administration regimens. Resulting data will 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. 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.
Debio 0932 demonstrated high potency in vitro and in vivo across a wide range of cancers. Most notably, Curis scientists observed complete tumor regression following oral administration of Debio 0932 in a mouse xenograft model of acute myelogenous leukemia (AML). Tumor regression has also been observed after treatment of Debio 0932 in mouse xenograft models of breast, non-small cell lung, gastric cancer and glioblastoma brain cancers. In this preclinical testing, the compound also demonstrated an ability to effectively cross the blood brain barrier, and demonstrated an ability to extend survival in an intracranial glioblastoma model. GLP toxicity studies suggest that Debio 0932 appears to be well tolerated at potentially efficacious doses.
About the Debiopharm License Agreement
On August 6, 2009, Curis entered into a license agreement with Debiopharm S.A., a Swiss corporation. Pursuant to the license agreement, Curis granted to Debiopharm a worldwide, exclusive royalty-bearing license with the right to grant sublicenses to develop, manufacture, market and sell any product containing the Company’s Hsp90 inhibitor technology, including Curis’ lead Hsp90 compound under development, CUDC-305 (since renamed Debio 0932). Debiopharm will assume all future development responsibility and incur all future costs related to the development, registration and commercialization of products under the agreement. Curis is eligible to receive up to an aggregate of $90 million in payments, as well as royalties on sales by Debiopharm or its sublicensees.
About Hsp90
Hsp90 is a member of a class of proteins called molecular chaperones that play a fundamental role in the folding, stabilization and degradation of their client proteins under normal or stressful conditions. Hsp90, in particular, has become an attractive therapeutic target for the treatment of cancer because a majority of its client proteins are involved in cellular signaling transduction and have been identified as potential contributors to various aspects of cancer cell growth and survival. Inhibitors of Hsp90 activity may be of therapeutic value if they can prevent Hsp90 chaperones from protecting proteins involved in cancer and allow them to be degraded.
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