Synedgen to Partner with the NIH for Radiation Countermeasures Product Development
Synedgen Active Agent SY303A will undergo Further Non-Clinical Efficacy Testing at the Armed Forces Radiobiology Research Institute (AFRRI), in Bethesda, Maryland
November 13, 2012—Claremont CA—The National Institute of Allergy and Infectious Diseases (NIAID) Radiation’s Nuclear Medical Countermeasures program (NIH) has announced a plan to accelerate the development of Synedgen’s radiation countermeasures drug product, SY303A.
The NIH/NIAID Countermeasures Development Program supports research on highly promising medical products that have shown efficacy in the mitigation of lethality and possible treatment of injuries resulting from radiation exposure. The decision to accelerate the development of Synedgen’s SY303A was based on research studies that demonstrated decreased mortality and reduced damage to the GI tract in animals who received SY303A orally 24 hours after exposure to lethal ionizing radiation. This partnership will support further testing of the active ingredient in specialty laboratories designed to conduct studies in preparation for FDA licensure.
As part of the program, Synedgen scientists will work with the Armed Forces Radiobiology Research Institute (AFRRI) as the first NIH supported subcontractor and will supply the drug product. The unique resources of the Armed Forces Radiobiology Research Institute enable advancements in the protection of soldiers and citizens, and it is a recognized leader in ionizing radiation research. AFRRI collaborates with other government facilities, academic institutions, and civilian laboratories to research the biological effects of ionizing radiation, and provides medical training and emergency response to manage incidents related to radiation exposure. The NIH/NIAID will coadvise the non-clinical animal efficacy studies and toxicology testing at their test facilities to help support the validation of Synedgen’s therapeutic.
“We are extremely excited about this partnership and the opportunity to advance this needed product towards FDA approval,” stated Synedgen President Shenda Baker. “The NIH/NIAID will provide us with valuable guidance on the process of product development and licensure and open the door for further research and validation with other highly skilled contract laboratories.”
“We are pleased by the NIH/NIAID’s support and recognition of our efforts. We feel confident that SY303A could dramatically improve survivability following radiation exposure and may lead to further indications for our lead molecule to mitigate bowel inflammation due to other causes,” added Synedgen CEO William Wiesmann M.D.