Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a clinical stage biopharmaceutical company, announced today that the Food and Drug Administration (FDA) has completed its review and cleared the 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 2, 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," stated Stephen T Sonis, DMD, DMSc, Clinical Professor of Oral Medicine at Harvard School of Dental Medicine and 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."
"We are pleased that the FDA has cleared Soligenix's first IND for the recently acquired IDR technology," stated Christopher J. Schaber , PhD, President and Chief Executive Officer of Soligenix. "The initiation of the oral mucositis clinical program marks an important next step in the development of SGX942. We look forward to working with our esteemed Medical Advisory Board and clinical investigators to initiate this clinical study."