Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, announced today it has completed enrollment of the additional subjects, as directed by the Data Review Committee (DRC) earlier this year, into the company's Phase 2 study for SGX942. SGX942 is a first-in-class innate defense regulator (IDR) and is being evaluated as a treatment for oral mucositis in patients undergoing chemoradiation (CRT) therapy for head and neck cancer. Consistent with prior guidance, Soligenix anticipates reporting preliminary results in the fourth quarter of 2015.
This Phase 2 study is a randomized, double-blind, dose-ranging, placebo-controlled trial, initially set to enroll approximately 75 subjects across 3 SGX942 dose groups and a placebo group, focused on demonstrating the safety and biologic activity of SGX942 in patients with cancer of the mouth and oropharynx who often experience debilitating oral mucositis as a consequence of their treatment with CRT. Following the DRC review of available data on the subjects enrolled in the trial, the committee recommended that enrollment include at least an additional 20 subjects randomized into either a single SGX942 dose group or the placebo group to allow for a more targeted assessment of the drug's potential effect and to inform final dose selection in this patient population. The efficacy assessment is the comparison of the incidence and/or duration of both ulcerative and severe oral mucositis throughout the subjects' 7 week course of CRT and for an additional 4 weeks thereafter.
"We are pleased to announce the important milestone of enrollment completion in this study aimed at treating this unmet medical need," said Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We appreciate the efforts of the clinicians involved with the study as well as the participation from the patients. We are looking forward with great anticipation to announcing the results of this study later this year."
SOURCE Soligenix, Inc.