Debiopharm Group™ Starts Phase I Clinical Trial with Debio 0932
News Apr 28, 2010
Debiopharm Group™ (Debiopharm) announced that it has started patient enrolment in its Phase I clinical trial for the small molecule inhibitor of heat shock protein 90 (Hsp90), Debio 0932. This trial will evaluate the maximum tolerated dose and safety of Debio 0932 in patients suffering from advanced solid tumors or lymphoma.
“The advancement of Debio 0932 into the clinic is an important step for us. Debiopharm has made a substantial commitment to the development of this Hsp90 inhibitor,” said Rolland-Yves Mauvernay, President and Founder of Debiopharm Group™. “The preclinical work carried out by Curis suggests that Debio 0932 may be able to enhance the efficacy of treatment against certain tumors, where there currently is a large unmet medical need. This collaboration adds an important new component to our development pipeline.”
Debio 0932 was licensed-in from Curis in August 2009. After having shown efficacy in mice in various tumor xenografts, Debio 0932 has now entered clinical development. The first part of the study (Phase Ia) is an open-label, multi-centre dose escalation trial evaluating the safety and tolerability of escalating multiple dose-levels of Debio 0932 as a single agent given orally to patients suffering from advanced solid tumors or lymphoma.
The dose-limiting toxicities, maximum tolerated dose, and pharmacokinetic parameters will be determined 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.
Debiopharm expects to treat up to 80 patients in the Phase Ia portion of the trial. Once the recommended dose is determined, up to 40 additional patients may be treated at the selected dose in the course of the Phase Ib expansion phase. The objective of this phase will be to further confirm the safety profile, pharmacokinetics and pharmacodynamics of Debio 0932 at a potential Phase II dose level and to screen anti-tumor activity in patients with certain types of advanced solid tumors.