A total of 96 patients randomized in France and Switzerland. Results expected in Q1 2019.
LAUSANNE, Switzerland, June 15, 2017 /CNW/ - Debiopharm International SA (Debiopharm - http://www.debiopharm.com), part of Debiopharm Group™, a Swiss-based global biopharmaceutical company, today announced the completion of enrollment in dose finding and efficacy phase I/II trial Debio 1143-201 for the treatment of locally advanced squamous cell carcinoma of the head and neck. The phase II portion of the study enrolled 96 patients and was conducted at 23 centers in France and Switzerland. Top-line results are expected in Q1 2019.
In this two-part trial Debio 1143 was combined with concurrent chemoradiotherapy (CRT) in patients with previously untreated stage III, IVa or IVb head and neck cancer. The primary study objectives were to determine the maximum tolerated dose in part A and to evaluate the anti-tumor activity of Debio 1143 in combination with CRT in part B.
"Completing enrolment in this study is an important achievement for this compound, and we are grateful to our investigators who have been incredibly supportive," said Chris Freitag, Vice President, Clinical Research & Development, Debiopharm International S.A. "There is still a lot of work ahead, but we can now focus on this important second phase of the study and look forward to the results in due course."
About Debio 1143
Debio 1143 is a small molecule that neutralizes inhibitor of apoptosis proteins (IAPs) by mimicking the activity of the natural Second Mitochondrial-derived Activator of Caspases (SMAC). Debio 1143 aims to improve cancer patient treatment outcomes by sensitizing cancer cells to the action of chemotherapy, radiotherapy, and/or immune checkpoint inhibitors. Debio 1143 is a potent orally available IAP inhibitor currently in development in Head and Neck, Ovarian, NSCLC and Breast cancer.
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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For further information: Debiopharm International SA Contact: Christelle Tur, Communication Coordinator, [email protected], Tel: +41(0)21-321-01-11