Debiopharm International SA Initiates Clinical Phase II Study Evaluating Debio 1143 in Ovarian Cancer
LAUSANNE, Switzerland, June 7, 2016 /PRNewswire/ --
Debiopharm International SA (Debiopharm), part of Debiopharm Group™, a Swiss-based global biopharmaceutical company, today announced the start of a clinical phase II study to evaluate the IAP inhibitor Debio 1143 for the treatment of Epithelial Ovarian Cancer (EOC) for which it recently received Orphan Drug Designation from both the European Medicine Agency and the Food and Drug Administration.
This study is designed to evaluate the efficacy of Debio 1143 given in combination with Carboplatin and Paclitaxel in a neo-adjuvant setting as compared to chemotherapy alone. Further to encouraging observations made in clinical phase I (NCT01930292), this trial aims at demonstrating the chemosensitizer effect of the compound in a double-blind design and at identifying biomarkers to be used for patients' stratification in pivotal studies. Safety and tolerability of Debio 1143 will also be evaluated by conventional endpoints.
"We are pleased to announce the start of this second phase II trial with Debio 1143 shortly after establishing the recommended dose and encouraging observations for the utility of Debio 1143 in EOC," said Dr Nigel McCracken, Vice President, Clinical Research & Development, Debiopharm International. "It is another illustration of Debiopharm's commitment to improve treatment outcomes for patients suffering from severely debilitating and life threatening conditions".
About Debiopharm International SA
Debiopharm Group™ is a Swiss-based global biopharmaceutical group of four companies active in drug development, GMP manufacturing of proprietary drugs, diagnostics, 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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