ImmuneRegen to study benefits of Radilex in radiation exposure to support FDA application

By Lisa Kerner

Charlotte, N.C., Aug. 30 - ImmuneRegen BioSciences said it began a study of its Radilex product to gather additional neutropenia and thrombocytopenia data.

The study results will be used to support ImmuneRegen's application to the Food and Drug Administration under the Animal Efficacy Rule to market Radilex for the treatment of the effects of acute radiation exposure.

FDA's rule allows for the approval based on studies of a product's effectiveness in animals rather than in humans, according to a company news release.

Decreases in blood neutrophils (neutropenia) and platelets (thrombocytopenia) following radiation exposure are believed to lead to infections and uncontrolled bleeding, as well as morbidity and mortality.

ImmuneRegen said previous studies indicate the possible benefits of Radilex to treat the effects of radiation exposure including radiation-induced neutropenia and thrombocytopenia.

In its latest study, the company will use its newly acquired additional instrumentation and the expertise of an aerosol scientist.

Additional studies are planned to examine Radilex activity in mice, as well as collaborative animal studies to further explore mechanisms of Radilex protection at the molecular level.

ImmuneRegen, a wholly owned subsidiary of IR BioSciences Holdings, Inc., is a development-stage biotechnology company based in Scottsdale, Ariz.

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