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news.Soligenix (SNGX), a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, announced that the National Institute of Allergy and Infectious Diseases (NIAID) has exercised its option to advance preclinical development of OrbeShield (oral beclomethasone 17,21-dipropionate or oral BDP).
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The 12-month option provides an additional $2.1 million to Soligenix to advance OrbeShield™ as a medical countermeasure (MCM) for the treatment of gastrointestinal acute radiation syndrome (GI ARS). NIAID granted the award of up to $6.4 million over three years on September 18, 2013.
Soligenix’s GI ARS program is supported by contract awards from both the Biomedical Advanced Research Development Authority (BARDA) and NIAID, totaling up to approximately $32 million. In addition to developing oral BDP as a MCM, the company is also pursuing oral BDP as a treatment for GI inflammation in pediatric Crohn’s disease and acute radiation enteritis.
"The execution of the second option reflects NIAID’s ongoing commitment to developing MCMs for GI ARS and the compelling nature of Soligenix’s OrbeShield™ product," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix.
"This continued funding, plus the BARDA contract awarded, has the potential to provide the necessary funding to advance the development of OrbeShield™ while building upon the scientific evidence supporting its use as a potential MCM in GI ARS. We thank NIAID for their past and present support and look forward to continuing our close collaboration as we advance this technology."
ARS occurs after toxic radiation exposure and involves several organ systems, notably the bone marrow, the GI tract and later the lungs. In the event of a nuclear disaster or terrorist detonation of a nuclear bomb, people exposed to radiation levels greater than 2 Gy are at high risk of developing ARS.
Exposure to high doses of radiation exceeding 10 to 12 Gy causes acute GI injury, which can result in death in 5 to 15 days. The GI tract is highly sensitive due to the requirement for incessant proliferation of crypt stem cells and production of mucosal epithelium.
The extent of injury to the bone marrow and the GI tract are the principal determinants of survival after exposure to total body irradiation. Although hematopoietic ARS can be rescued by bone marrow transplantation or growth factor administration, there is no established treatment or preventive measure for the GI damage that occurs after high-dose radiation. Therefore, there is an urgent need to develop specific MCMs against the lethal consequences of radiation-induced GI injury.