The US Food and Drug Administration (FDA) has completed review and cleared Soligenix, Inc.'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. The 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," 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 programme 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."

SGX942 is an IDR, a new class of short, synthetic peptides that has a novel mechanism of action in that it has simultaneous anti-inflammatory and anti-infective activity. IDRs have no direct antibiotic activity but modulate host responses, increasing survival after infections with a broad range of bacterial Gram-negative and Gram-positive pathogens, as well as accelerating resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation-therapy. SGX942 has demonstrated safety in a phase I clinical study in healthy human volunteers and efficacy in numerous animal disease models including mucositis, colitis, skin infection and other bacterial infections. SGX942 was developed pursuant to discoveries made by Professors B. Brett Finlay, PhD and Robert Hancock, PhD of the University of British Columbia, Canada and approximately $40 million has been put towards its development inclusive of government grants.

Mucositis is the clinical term for damage done to the mucosa by anticancer therapies (e.g., radiation or chemotherapy). It can occur in any mucosal region, but is most commonly associated with the mouth, followed by the small intestine. Mucositis can be severely debilitating and can lead to infection, sepsis, the need for parenteral nutrition and narcotic analgesia. The gastrointestinal damage causes severe diarrhoea. These symptoms can limit the doses and duration of cancer treatment, leading to sub-optimal treatment outcomes. The mechanisms of mucositis have been extensively studied and have been recently linked to the interaction of chemotherapy and/ or radiation therapy with the innate defense system. Bacterial infection of the ulcerative lesions is now regarded as a secondary consequence of dysregulated local inflammation triggered by therapy-induced cell death, rather than as the primary cause of the lesions.

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