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FDA Grants Soligenix Orphan Drug Designation for SGX94 for Treatment of Acute Radiation Syndrome
Date:9/16/2013

ng exclusivity that orphan drug designation imparts adds significantly to the existing patent estate surrounding SGX94." 

About ARS

ARS occurs after toxic radiation exposure and involves several organ systems, notably the skin, the bone marrow and the gastrointestinal (GI) 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. The chance of survival for people with ARS decreases with increasing radiation dose, with doses of 10-12 Gy causing death within 15 days and lower doses potentially causing death within a few months. The cause of death within 15 days of radiation exposure is usually damage to the GI tract whereas after 15 days death usually is a consequence of bone marrow (hematopoietic) injury. Symptoms of cutaneous (skin) radiation injury are recurring phenomena after ARS.  For the survivors, the recovery process may last from several weeks up to two years. Although the hematopoietic syndrome may be rescued by bone marrow transplantation or growth factor administration, the risk of death due to infection remains very high.  There is currently no established treatment or preventive measure for the GI damage that occurs after high-dose radiation.

About SGX94

SGX94 is an IDR, a new class of short, synthetic peptides that has a novel mechanism of action in that it has simultaneous anti-inflammatory and anti-infective activity.  IDRs have no direct antibiotic activity but modulate host responses, increasing survival after infections with a broad range of bacterial Gram-negative and Gram-positive pathogens, as well as accelerating resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation-therapy.  SGX94 has demonstrated safety in a Phase 1 clinical study in healthy human volunteers and efficacy in n
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