Debiopharm Initiates Phase I Dose Escalation Study with Debio 1347 (CH5183284)
News Sep 03, 2013
Debiopharm Group™ (Debiopharm) has 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.