Soligenix adds subjects for mucositis treatment study

Biopharmaceutical company Soligenix has completed enrollment of additional subjects in the phase II study for its SGX942 oral mucositis treatment.

SGX942 is an "innate defense regulator," according to the company, and it is being tested as an oral mucositis treatment in patients undergoing chemoradiation therapy for head and neck cancer. The company anticipates reporting preliminary results in the fourth quarter of 2015.

The phase II study is a randomized, double-blind, dose-ranging, placebo-controlled trial that initially enrolled approximately 75 subjects to demonstrate the safety and biologic activity of SGX942. As part of the study, researchers will compare the incidence and/or duration of both ulcerative and severe oral mucositis during the subjects' seven-week course of chemoradiation therapy and for four weeks after. Earlier this year, the data review committee directed the study to enroll at least an additional 20 subjects.

"We are pleased to announce the important milestone of enrollment completion in this study aimed at treating this unmet medical need," stated Christopher Schaber, PhD, president and CEO of Soligenix, in a press release. "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."

An innate defense regulator is a new class of short, synthetic peptides that have simultaneous anti-inflammatory and anti-infective activity, according to Soligenix. While these regulators have no direct antibiotic activity, they modulate host responses and increase survival after infections with a broad range of bacterial gram-negative and gram-positive pathogens, the company noted.

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