A -- PHARMACOLOGICAL COUNTERMEASURES TO IONIZING RADIATION

It is the intent of the Uniformed Services University of the Health Sciences (USUHS), to negotiate on a sole-source basis with Humanetics Pharmaceuticals, Chanhassen, MN, to identify and investigate if an Investigational New Drug, BIO 300, can be used as a countermeasure for exposure to ionizing radiation. Humanetics Pharmaceuticals will explore the application of the BIO 300 in basic and clinical research studies. Humanetics Pharmaceuticals will conduct three research studies: 1) A Dose Escalation Trial Evaluating the Safety and Pharmacokinetics of BIO 300 Capsules at Five Doses in Humans. The intent of this clinical trial is to develop additional pharmacokinetic and safety data for BIO 300 capsules in humans at the dose level anticipated for efficacy based upon preclinical studies.; 2) A Dose Escalation Trial Evaluating the Safety and Pharmacokinetics of BIO 300 Capsules at Five Doses in a Large Animal Model. The intent of this large animal trial is to maximize information collected from animals while considering their biological similarities to humans. The animal species selected should be similar to humans with respect to the pharmacokinetic profile of the agent. The selection of an appropriate animal species for this work requires a comprehensive evaluation of those variables that are specific to the disease process that is being studied.; 3) Mathematical Molecular Modeling to Screen Agents for Potential Use as Medical Radiation Countermeasures. Exposure to high levels of ionizing radiation may cause deficits in the immune system, along with other syndromes known collectively as acute radiation syndrome (ARS). High mortality rates can occur in as little as two to four weeks after exposure to radiation if the immune system is negatively affected. The Contractor is required to develop, or license the ability to utilize, a computer model to mathematically characterize the two-dimensional molecular topology of known radioprotectants or radiotherapeutics as a means to generate a training set that will predict other compounds with similar mathematical attributes and characteristics. Potential compounds identified by the mathematical model will subsequently be assayed in an animal screening model by the Government to determine levels of efficacy. The objective is to utilize the mathematical model to generate new lead candidates for development as radioprotectants or radiotherapeutics. The period of performance will be for two years with the option to extend services. The statutory authority permitting this award under other than full and open competition is 10 U.S.C. 2304(c)(1), as cited in FAR 6.302-1(a) that authorizes USUHS to award contracts when only one responsible source and no other supplies or services will satisfy agency requirements.