The US Food and Drug Administration (FDA) has granted Fast Track  designation to Soligenix, Inc.'s  SGX942 development programme for the treatment of oral mucositis as a result of radiation and/or chemotherapy treatment in head and neck cancer patients.

Fast track is a designation that the FDA reserves for a drug intended to treat a serious or life- threatening condition and one that demonstrates the potential to address an unmet medical need for the condition. Fast track designation is designed to facilitate the development and expedite the review of new drugs. For instance, should events warrant, Soligenix will be eligible to submit a new drug application (NDA) for SGX942 on a rolling basis, permitting the FDA to review sections of the NDA prior to receiving the complete submission.

 Additionally, NDAs for fast track development programmes ordinarily will be eligible for priority review, which imparts an abbreviated review time of approximately six months.  

"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."

"There are no FDA approved drugs for the treatment of oral mucositis in head and neck cancer patients," stated Christopher J. Schaber, president and chief executive officer of Soligenix. "We believe that the FDA's action in granting fast track designation is a validation of the potential of SGX942 to address this life-threatening, unmet medical need. We look forward to working closely with the FDA to expedite the SGX942 development programme."

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 1 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,and Robert Hancock, of the University of British Columbia, Canada and approximately $40 million has been put towards its development to date, inclusive of government grants.

Mucositis is the clinical term for damage done to the mucosa by anticancer therapies. It can occur in any mucosal region, but is most commonly associated with the mouth, followed by the small intestine. It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of mucositis, that mucositis affects approximately 500,000 people in the US per year and occurs in 40% of patients receiving chemotherapy. Mucositis can be severely debilitating and can lead to infection, sepsis, the need for parenteral nutrition and narcotic analgesia. The gastro-intestinal 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 a clinical stage biopharmaceutical company developing products to treat serious gastrointestinal diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics.