Debiopharm International SA Initiates Clinical Phase II Study Evaluating Debio 1143 in Ovarian Cancer
News Jun 09, 2016
Debiopharm International SA (Debiopharm), part of Debiopharm Group™, a Swiss-based global biopharmaceutical company, 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”.