Patent Law Practice Center

Orphan Drug Designation for Total Body Irradiation Treatment

Soligenix, Inc. (OTCQB: SNGX), a development stage biopharmaceutical company, recently announced that the Office of Orphan Products Development of the US Food and Drug Administration (FDA) has granted orphan drug designation to OrbeShield™ (oral beclomethasone 17,21-dipropionate or oral BDP), which is for the prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster.

Oral BDP is a highly potent, topically active corticosteroid that has a local effect on inflamed tissue.  BDP is the active ingredient in OrbeShield™, currently being developed for the treatment of gastrointestinal acute radiation syndrome (GI ARS), the driving component in early mortality following high doses of total body irradiation (TBI).

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