Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a clinical stage biopharmaceutical company, announced today that its SGX942 development program for the treatment of oral mucositis as a result of radiation and/or chemotherapy treatment in head and neck cancer patients has received "Fast Track" designation from the US Food and Drug Administration (FDA).
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 programs 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 , PhD, 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 program."