Soligenix Receives Positive Scientific Advice from the European Medicines Agency for SGX942 in the Treatment of Oral Mucositis in Head and Neck Cancer Patients
PRINCETON, N.J., Jan. 5, 2017 /PRNewswire/ -- Soligenix, Inc. (SNGX), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the company had received positive Scientific Advice from the European Medicines Agency (EMA) for the development of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy. The Scientific Advice from the EMA indicates that a single, double-blind, placebo-controlled, multinational, Phase 3 pivotal study (IDR-OM-02), if successful, in conjunction with the Phase 2 dose-ranging study IDR-OM-01, is generally considered sufficient to support a marketing authorization application (MAA) to the EMA for potential licensure in Europe. The advice also provides several constructive suggestions to strengthen the study design and data collection that will be integrated into the final protocol.
"We are pleased that the EMA agrees that the proposed Phase 3 clinical study, if positive, is sufficient to establish the efficacy of SGX942 and support an MAA filing," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We believe that this positive Scientific Advice outcome represents a significant step forward in our oral mucositis development program and has the potential to accelerate the registration timetable in Europe. We look forward to incorporating the EMA's protocol suggestions with those from the US Food and Drug Administration. Given the current timeline, we anticipate initiating this pivotal Phase 3 clinical trial in the first half of 2017."
