ImmuneRegen to hold animal trials of radiation drug Radilex at Oak Ridge National Laboratory

By Angela McDaniels

Seattle, Dec. 7 - ImmuneRegen BioSciences, a subsidiary of IR BioSciences Holdings Inc., said it will initiate its final rodent studies of Radilex as a treatment for acute radiation sickness at the Oak Ridge National Laboratory.

"Oak Ridge has decades of experience in the evaluation of the consequences of radiation exposure. We welcome a role in helping evaluate the promise of new therapeutic compounds that might ameliorate the effects of high radiation doses to humans," Dabney Johnson of the laboratory's Life Sciences Division said in a company news release.

The preclinical trials are expected to being in early January and are part of an recently signed agreement between Oak Ridge and ImmuneRegen for a series of trials, the company said.

The final mouse studies were requested by the National Institutes of Health in February 2005, with the specification that ImmuneRegen follow the format of radiation sickness studies done by the Armed Forces Radiobiology Research Institute as a guideline.

The purpose of the studies is to provide more rigorous confirmation evidence supporting the efficacy of Radilex as a treatment to a lethal dose of radiation exposure. Several factors are being evaluated, including dosage, route of administration and need for, and extent of, required pretreatment, the company said.

"We anticipate these final rodent studies to not only support our rapid progress, in conformance with the Animal Efficacy Rule, toward Food and Drug Administration approval for treating acute radiation sickness, but also to help demonstrate Radilex's potential as a universal protectant," says ImmuneRegen chief executive officer Michael Wilhelm in the release.

ImmuneRegen said Radilex can potentially be used as a countermeasure against lethal gamma radiation exposure. In past tests in rodents, Radilex has shown a survival rate of roughly 50% after lethal radiation exposure.

ImmuneRegen BioSciences, based in Scottsdale, Ariz., develops Homspera and its derivatives Radilex and Viprovex as a family of countermeasures for multiple homeland security threats, including chemical agents, acute radiation sickness from a dirty bomb or nuclear disaster and infectious disease/biological warfare scenarios.

Oak Ridge supports the Department of Energy through six scientific competencies: neutron science, energy, high performance computing, complex biological systems, advanced materials and national security. It is located in Oak Ridge, Tenn.

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