The FDA cleared the Soligenix’s Investigational New Drug (IND) application for SGX942 for the treatment of oral mucositis resulting from radiation and/or chemotherapy treatment in head and neck cancer patients.

Clearance of the IND allows Soligenix to initiate a phase II, randomized, double-blind, placebo-controlled, dose-escalating clinical study of SGX942 in patients being treated for head and neck cancer. The trial is expected to be initiated in the second half of 2013.

"Oral mucositis is a significant unmet medical need which ultimately impacts the tolerability of radiation and chemotherapy and therefore the survivability of cancer," said Stephen T Sonis, DMD, DMSc, a member of the Soligenix oral mucositis medical advisory board. "The lack of an effective treatment has frustrated healthcare providers and caused misery for innumerable patients. As an innate defense regulator (IDR), SGX942 directly targets a fundamental biological mechanism which leads to mucosal injury caused by radiation and chemotherapy."

Soligenix is a clinical stage biopharmaceutical company developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics.