PRINCETON, N.J., Jan. 4, 2013 /PRNewswire/ -- Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a development stage biopharmaceutical company, announced today that the Food and Drug Administration (FDA) has completed its review and cleared the Investigational New Drug (IND) application for OrbeShield TM (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 TM 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.
"We are very excited to advance the development of OrbeShield TM which we believe has the potential to be a safe and effective medical countermeasure in the event of a nuclear attack or radiation accident," stated Kevin Horgan, MD, Senior Vice President & Chief Medical Officer of Soligenix. "We believe our proprietary two-tablet system has the pharmacological, clinical and manufacturing attributes necessary to potentially provide a substantial contribution to our national defense response systems so that we are optimally prepared in the event of a public health emergency such as nuclear accident or terrorist attack."
About GI-ARSARS occurs after toxic radiation exposure and involves several organ systems, notably the bone marrow the GI tract and later the lungs. 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. Exposure to high doses of radiation exceeding 10-12 Gy causes acute GI injury which can result in death in 5-15 days. The GI tract is highly sensitive due to the requirement for incessant proliferation of crypt stem cells and production of mucosal epithelium. The extent of injury to the bone marrow and the GI tract are the principal determinants of survival after exposure to TBI. Although the hematopoietic syndrome can be rescued by bone marrow transplantation or growth factor administration, there is no established treatment or preventive measure for the GI damage that results from high-dose radiation exposure. Therefore, there is an urgent need to develop specific medical countermeasures against the lethal pathophysiological manifestations of radiation-induced GI injury.