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Debiopharm Group™ starts Phase I clinical trial with Debio 0932

- A targeted small molecule inhibitor of heat shock protein 90 for cancer treatment -

Lausanne, Switzerland – April 27, 2010 - Debiopharm Group™ (Debiopharm), a Swiss-based global biopharmaceutical group of companies with a focus on the development of innovative prescription drugs that target unmet medical needs, and which has embarked in the field of companion diagnostics with a view to progressing in the area of personalised medicine, today 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 tumours 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 tumours, where there currently is a large unmet medical need. This collaboration adds an important new component to our development pipeline.”

Aim of Phase I clinical trial
Debio 0932 was licensed-in from Curis in August 2009. After having shown efficacy in mice in various tumour 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-tumour activity in patients with certain types of advanced solid tumours.

About Debiopharm Group™
Debiopharm Group™ (Debiopharm) is a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs. The group in-licenses, develops and/or co-develops promising biological and small molecule drug candidates having reached clinical development phases I, II or III. Debiopharm is also prepared to consider earlier stage candidates. It develops its products for global registration and maximum commercial potential. The products are out-licensed to pharmaceutical partners for sales and marketing. Besides drug development, Debiopharm Group™ has recently embarked in the field of companion diagnostics with a view to progressing in the area of personalised medicine.
Debiopharm independently funds the worldwide development of all of its products while providing expertise in pre-clinical and clinical trials, manufacturing, drug delivery and formulation, and regulatory affairs.
For more information on Debiopharm Group™, please visit: www.debiopharm.com

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Debiopharm S.A. Contact 
Maurice Wagner
Director Corporate Affairs & Communication
Tel.: +41 (0)21 321 01 11
Fax: +41 (0)21 321 01 69
mwagner@debiopharm.com
 

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