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Biodefense Applications of Our Proteins– Acute Radiation Syndrome

The U.S. government is actively supporting identification and development of drugs to prevent or treat the complications of acute, high dose radiation exposure, such as might occur following a nuclear accident or a terrorist nuclear attack. Acute, high dose radiation exposure causes a well characterized set of radiation dose-dependent and time-dependent organ malfunctions that can lead to severe morbidity and death (referred to as Acute Radiation Syndrome or ARS). Tissues differ in their sensitivities to radiation exposure, primarily due to differences in the number and turnover of stem cells within each tissue. Bone marrow is one of the most radiation-sensitive tissues, and patients exposed to high dose radiation typically develop severe neutropenia, anemia, thrombocytopenia and lymphopenia within 2-3 weeks of exposure. Many patients die as a result of their body’s inability to fight infections (due to lack of neutrophils) or control bleeding (due to lack of platelets). Patients that survive the early hematopoietic complications of high dose radiation exposure may develop gastrointestinal, lung, kidney and other organ problems over the ensuing months and years, depending upon their level of radiation exposure. Our long-acting hematopoietic growth factors BBT-015 (G-CSF analog), BBT-059 (IL-11 analog) and murine BBT-007 homolog (murine GM-CSF analog) have proven very effective at accelerating hematopoietic recovery and improving survival in animal ARS models. Products to treat ARS will be approved under the FDA’s “Animal Rule” approval pathway since it is not ethical to test these drugs in humans. The approval process requires demonstrating that the drug is effective (improves survival or decreases severe morbidity) in validated animal ARS models and is safe for use in humans. Products that receive FDA approval for treating ARS may be purchased by the government for inclusion in the Strategic Nuclear Stockpile for use in case of a radiological/nuclear emergency.

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