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Clinical Trials

Date: 2014-11-18

Type of information: Presentation of results at a congress

phase: 1

Announcement: presentation of results at the 26th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, in Barcelona, Spain, on November 18-21, 2014.

Company: Debiopharm (Switzerland)

Product: Debio 1347 (CH5183284)

Action mechanism:

Debio 1347/CH5183284 is a selective oral fibroblast growth factor receptor (FGFR) 1, 2, 3 inhibitor that has shown anti-cancer efficacy in several preclinical animal models in vivo.

Disease:

advanced solid tumours with FGFR alterations

Therapeutic area: Cancer - Oncology

Country: Europe, USA

Trial details:

Latest news:

* On November 18, 2014, Debiopharm, a Swiss-based global biopharmaceutical company developing prescription drugs along with companion diagnostics to target unmet medical needs, announced that new data on Debio 1347/CH5183284 (FGFR 1,2,3 inhibitor) will be presented at the 26th European Organization for Research and Treatment of Cancer (EORTC), National Cancer Institute (NCI) and American Association for Cancer Research (AACR) (EORTC-NCI-AACR) Annual Meeting, November 18 to 21, 2014, to be held in Barcelona. Abstract number 547 will summarize the data obtained with Debio 1347/CH5183284, a highly selective, oral, fibroblast growth factor receptor (FGFR) 1, 2, 3 inhibitor. This compound is currently being evaluated in a first-in-man, phase I trial in patients with specific alterations of the FGFR genes. Strong activity of the compound in animal models with either a FGFR fusion or amplification will be disclosed.

* On May 28, 2014, Debiopharm, a Swiss-based global biopharmaceutical company developing prescription drugs that target unmet medical needs as well as companion diagnostics, announced that new data on Debio 1347/CH5183284 (FGFR 1,2,3 inhibitor) will be presented at the 50th American Society of Clinical Oncology (ASCO) Annual Meeting, May 30 to June 3, 2014, in Chicago. Debio 1347/CH5183284 will enable personalized treatments and will be developed with a companion diagnostic. Debio 1347/CH5183284 is currently being evaluated in Europe and USA, in a first-in-man phase I trial in patients with advanced solid tumors displaying alterations of the FGFR 1, 2, or 3 genes.

Abstract presented at ASCO: First-in-human phase I “basket” study of Debio1347 (CH5183284), a novel FGFR inhibitor, in patients with FGFR genomically activated advanced solid tumors. #TPS2629
* On September 2, 2013, 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.
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.

Is general: Yes