Soligenix announced that the FDA has granted Orphan Drug designation to the active ingredient SGX94 for the treatment of acute radiation syndrome (ARS). SGX94 is an innate defense regulator (IDR), a new class of short, synthetic peptides that accelerates resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma, radiation and/or chemotherapy. 

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SGX94 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.

ARS occurs after toxic radiation exposure and involves several organ systems, notably the skin, the bone marrow and the gastrointestinal tract.   In the event of a nuclear disaster or terrorist detonation of a nuclear bomb, casualties exposed to >2 Gy are at high risk for development of clinically significant ARS.  There is currently no established treatment or preventive measure for the GI damage that occurs after high-dose radiation.

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