Debiopharm Group™ initiates phase I dose escalation study with Debio 1347 (CH5183284) in advanced solid tumors with FGFR alterations

Lausanne, Switzerland – September 2nd, 2013 – Debiopharm Group™ (Debiopharm), the Swiss-based global biopharmaceutical company that focuses on the development of prescription drugs that target unmet medical needs including oncology, today announced the start of a phase I, open label multicenter study of a selective FGFR 1, 2, 3 inhibitor, Debio 1347 (CH5183284) in patients with advanced solid tumors.

The aim of the study is to identify the dose limiting toxicity (DLT) and to estimate the maximal tolerated dose (MTD) of Debio 1347 (CH5183284) based on the safety and tolerability of the product during a daily oral administration to patients suffering from advanced solid malignancies that have an alteration of the FGFR 1, 2 or 3 genes (fibroblast growth factor receptor). During an expansion part, the study will also evaluate the safety profile at the recommended dose of Debio 1347 (CH5183284) in a larger cohort of patients.

“We are delighted to initiate this first clinical phase I study with Debio 1347 (CH5183284)” said Rolland-Yves Mauvernay, President and founder of Debiopharm Group. “Debio 1347 (CH5183284) is going to be developed with a companion diagnostic and we believe it could become a personalized treatment option for patients suffering from solid tumors which could significantly improve their outcomes”.

In December 2012, Debiopharm signed an exclusive license agreement with Chugai Pharmaceutical Co., Ltd for the development and commercialization of Debio 1347 (CH5183284) in all countries worldwide including Japan. Eight months after executing the deal, Debio 1347 (CH5183284) is being tested in a phase I in several oncology centers of excellence in the USA and Europe.

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, as well as earlier stage candidates. It develops its products for global registration and access to the largest number of patients worldwide. The products are out-licensed to pharmaceutical partners for sales and marketing. Debiopharm is also active in the field of companion diagnostics with a view to progressing in the area of personalized 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.
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