Debiopharm International SA Announces Results from Phase I Dose-Escalation Study of Debio 1347/CH5183284

Debio 1347/CH5183284 was evaluated in patients with FGFR genomically activated advanced solid tumors

Lausanne, Switzerland – June 1, 2017 – Debiopharm International SA (Debiopharm –, part of Debiopharm Group™, a Swiss-based global biopharmaceutical company, today announced the results from the phase I dose-escalation study evaluating the compound Debio 1347/CH5183284 (FGFR 1,2,3 selective inhibitor). The data will be presented at the 53rd American Society of Clinical Oncology (ASCO) Annual Meeting by Martin H. Voss, MD, Medical Oncology at the Memorial Sloan Kettering Cancer Center in New York.

“We are very pleased to have reached this milestone and to be able to see these very interesting and promising results presented at the upcoming ASCO meeting. Despite not reaching the MTD, we are confident to have reached the right dose for phase 2 – given the indicators of anti-tumor activity that we have seen”, said Chris Freitag, VP Clinical Research & Development.

Oral Abstract Session: Developmental Therapeutics – Clinical Pharmacology and Experimental Therapeutics

  • Title: Debio1347, an oral FGFR inhibitor: Results from a first-in-human, phase I dose-escalation study in patients with FGFR genomically activated advanced solid tumors.
  • Date: Sat., June 3
  • Time: 1:15-1:27
  • N°: #2500

About Debio 1347/CH5183284
Debio 1347/CH5183284, created by Chugai Pharmaceutical. Co., Ltd., is an orally available small molecule targeting FGFR 1, 2, 3 signaling pathways. Debiopharm International SA completed the dose escalation portion of the first-in-human phase I study. Debio 1347/CH5183284 had a manageable safety profile. Encouraging antitumor activity was seen in several tumor types, mainly in patients with FGFR2 or 3 gene alterations, including fusion events. Efficacy will be further explored in disease-specific and molecularly defined expansion cohort.

About Debiopharm International SA
Part of Debiopharm Group™ – a Swiss-headquartered global biopharmaceutical group including five companies active in the life science areas of drug development, GMP manufacturing of proprietary drugs, diagnostic tools and investment management – Debiopharm International SA is focused on the development of prescription drugs that target unmet medical needs. The company in-licenses and develops promising drug candidates. The products are commercialized by pharmaceutical out-licensing partners to give access to the largest number of patients worldwide.
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