Debiopharm Group(TM) Starts Phase I Clinical Trial With Debio 0932

Tuesday, April 27, 2010 General News
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LAUSANNE, Switzerland, April 27, 2010 DebiopharmGroup(TM) (Debiopharm), a Swiss-based global biopharmaceutical group ofcompanies with a focus on the development of innovative prescription drugsthat target unmet medical needs, and which has embarked in the field ofcompanion diagnostics with a view to progressing in the area of personalisedmedicine, today announced that it has started patient enrolment in its PhaseI clinical trial for the small molecule inhibitor of heat shock protein 90(Hsp90), Debio 0932. This trial will evaluate the maximum tolerated dose andsafety of Debio 0932 in patients suffering from advanced solid tumours orlymphoma.

"The advancement of Debio 0932 into the clinic is an important step forus. Debiopharm has made a substantial commitment to the development of thisHsp90 inhibitor," said Rolland-Yves Mauvernay, President and Founder ofDebiopharm Group(TM). "The preclinical work carried out by Curis suggeststhat Debio 0932 may be able to enhance the efficacy of treatment againstcertain tumours, where there currently is a large unmet medical need. Thiscollaboration 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 shownefficacy in mice in various tumour xenografts, Debio 0932 has now enteredclinical development. The first part of the study (Phase Ia) is anopen-label, multi-centre dose escalation trial evaluating the safety andtolerability of escalating multiple dose-levels of Debio 0932 as a singleagent given orally to patients suffering from advanced solid tumors orlymphoma.

The dose-limiting toxicities, maximum tolerated dose, and pharmacokineticparameters will be determined to guide the recommended Phase Ib dose andschedule. The secondary objective will be to assess whether changes inpharmacodynamic biomarkers indicative of Hsp90 inhibition by Debio 0932 canbe reliably measured in patient samples.

Debiopharm expects to treat up to 80 patients in the Phase Ia portion ofthe trial. Once the recommended dose is determined, up to 40 additionalpatients may be treated at the selected dose in the course of the Phase Ibexpansion phase. The objective of this phase will be to further confirm thesafety profile, pharmacokinetics and pharmacodynamics of Debio 0932 at apotential Phase II dose level and to screen anti-tumour activity in patientswith certain types of advanced solid tumours.

About Debiopharm Group(TM)

Debiopharm Group(TM) (Debiopharm) is a Swiss-based globalbiopharmaceutical group of companies with a focus on the development ofprescription drugs that target unmet medical needs. The group in-licenses,develops and/or co-develops promising biological and small molecule drugcandidates having reached clinical development phases I, II or III.Debiopharm is also prepared to consider earlier stage candidates. It developsits products for global registration and maximum commercial potential. Theproducts are out-licensed to pharmaceutical partners for sales and marketing.Besides drug development, Debiopharm Group(TM) has recently embarked in thefield of companion diagnostics with a view to progressing in the area ofpersonalised medicine.

Debiopharm independently funds the worldwide development of all of itsproducts while providing expertise in pre-clinical and clinical trials,manufacturing, drug delivery and formulation, and regulatory affairs.

For more information on Debiopharm Group(TM), please visit:http://www.debiopharm.comDebiopharm S.A. Contact Maurice Wagner Director Corporate Affairs & Communication Tel.: +41(0)21-321-01-11 Fax: +41(0)21-321-01-69 Additional Media Contacts In London Maitland Brian Hudspith Tel: +44(0)20-7379-5151 In New York Russo Partners, LLC Martina Schwarzkopf, Ph.D. Account Executive Tel: +1-212-845-4292 Fax: +1-212-845-4260

SOURCE The Debiopharm Group

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