PRINCETON, N.J., Jan. 7, 2013 /PRNewswire/ -- Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a development stage biopharmaceutical company, announced today that pursuant to review of the Company's white paper on development of OrbeShield™ as a countermeasure for the gastrointestinal effects of acute radiation syndrome (GI ARS), the Biomedical Advanced Research and Development Authority (BARDA), Division of Chemical, Biological, Radiological and Nuclear (CBRN) Medical Countermeasures has informed the Company that after careful analysis and consideration, it is inviting Soligenix to submit a full proposal for a potential multi-year, multi-million dollar contract to develop OrbeShield ™ from its current level of technical readiness to FDA approval.
Soligenix submitted its white paper entitled "OrbeShield™, oral beclomethasone 17,21-dipropionate (BDP), a candidate broad spectrum therapeutic countermeasure for GI ARS," to BARDA in response to a Broad Agency Announcement (BARDA-BAA-12-
100-SOL-00011) for advanced research and development of medical countermeasures for chemical, biological, radiological and nuclear threats. BARDA is interested in the advanced development and eventual licensure/approval of effective medical countermeasures that mitigate, treat, affect, delay, or interrupt the progression of injuries resulting from an acute exposure to radiation from a radiological/nuclear accident or attack, particularly injuries associated with ARS.
In a canine model of GI ARS, OrbeShield™ demonstrated a statistically significant survival advantage in animals that received OrbeShield™ therapy up to 24 hours following exposure to lethal doses of total body irradiation (TBI) when compared with placebo control animals (p=0.04). Median survival post TBI exposure in the control group was 8 days, compared to 87 days in the OrbeShield™ treated group. A subsequent study to replicate and expand upon the observations made in the canine model is being initiated and, like the previous study, is supported by a recent National Institute of Allergy and Infectious Diseases (NIAID) Small Business Innovation Research (SBIR) grant award.