Soligenix, a development stage biopharmaceutical company focused on treatments for gastrointestinal diseases, has submitted a full contract proposal to the Biomedical Advanced Research and Development Authority (BARDA) Division of Chemical, Biological, Radiological, and Nuclear (CBRN) Medical Countermeasures. This submission is in regards to a potential multi-year, multi-million dollar contract to develop OrbeShield as a medical countermeasure (MCM) to treat gastrointestinal acute radiation syndrome (GI ARS), a condition that can occur after toxic radiation exposure.
BARDA invited Soligenix to submit its proposal in response to a Broad Agency Announcement for advanced research and development and eventual licensure/approval of effective MCMs to address injuries resulting from acute exposure to radiation from a nuclear accident or attack.
Though Soligenix’ submission of its proposal is non-binding and does not guarantee the award
of a BARDA contract, which is contingent upon review, acceptance, and negotiation, the company said it is confident it can provide adequate evidence of its technology.
“We are excited about the contract proposal submission to BARDA,” Christopher J. Schaber, PhD, president and CEO of Soligenix stated in the press release. “Although there are no guarantees, we believe that we are well-positioned to receive BARDA development support for this indication allowing us to further demonstrate the growing body of compelling scientific evidence supporting OrbeShield’s potential as a countermeasure for GI ARS. Having recently received Orphan Drug and Fast Track designations from the FDA, we look forward to continued productive interactions with BARDA, NIAID and FDA as we move the OrbeShield GI ARS development program forward.”
In a canine model of GI ARS, OrbeShield achieved statistically significant results up to 24 hours following exposure to lethal doses of total body irradiation when compared with placebo-control animals. Soligenix is conducting a subsequent study to replicate and expand on the canine model, supported by a $600,000 Small Business Innovation Research (SBIR) grant award from the NIAID.
For more information, visit www.soligenix.com
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