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Soligenix Inc Receives IND Clearance From FDA To Initiate Program Evaluating OrbeShield As Therapy for Gastrointestinal Acute Radiation Syndrome

Friday, 4 Jan 2013 07:00am EST 

Soligenix Inc announced that the Food and Drug Administration (FDA) has completed its review and cleared the Investigational New Drug (IND) application for OrbeShield (oral beclomethasone 17,21-dipropionate or oral BDP) for the mitigation of morbidity and mortality associated with the gastrointestinal acute radiation syndrome (GI-ARS). Soligenix has previously received Orphan Drug Designation for oral BDP for the prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster. Clearance of the IND allows Soligenix to initiate the development program which will include safety and efficacy evaluations conducted in appropriate preclinical models as well as a Phase 1/2 pharmacokinetic (PK)/pharmacodynamic (PD) study of OrbeShield in healthy adolescents and young adults. The PK/PD data from the Phase 1/2 study will provide the needed data to inform dose extrapolation from the animal studies to the appropriate dose in humans. 

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