SBIR-STTR Award

Members of the Joint Forces require a medial countermeasure against ionizing radiation induced injuries, including acute radiation syndrome (ARS), that can be administered before exposure and the onset of symptoms. To address this critical need, ChromoLogic LLC in collaboration with the University of Pittsburgh, has developed a JP4-039-MLV radioprotective drug, comprised of two key elements: 1) the radioprotective nitroxide, JP4-039, that targets the mitochondria and scavenges free radicals and electrons escaping from the electron transfer chain, thereby lowering radiation-induced tissue damage; and, 2) a multilamellar vesicle (MLV) drug delivery platform capable of encapsulating high concentrations of the hydrophobic radioprotector and enabling sustained release of the drug to provide long-term protection while reducing the frequency of administration. The JP4-039 drug has been shown to improve survival in vivo when administered both before and after exposure to x-ray, proton, and neutron irradiation. The MLV nanoparticles are monodisperse, surface-functionalized in order to evade clearance, and readily produced in large scale. The particles are stable in lyophilized form, allowing long-term storage of the drug under harsh environmental conditions.

In order to meet the DoD’s need for a prophylactic medical countermeasure to reduce the risk of acute radiation syndrome (ARS) when taken before exposure to ionizing radiation, ChromoLogic proposes to develop multilamellar vesicle-encapsulation JP4-039 (JP4-039-MLV) as a radioprotector of ionizing radiation (IR)-induced health risks. DoD personnel, such as members of the Joint Forces, would self-administer JP4-039-MLV prior to operating in a known, high risk IR environment. A single dose of JP4-039-MLV would provide protection from ARS for 72 h. In Phase II, ChromoLogic will build on the successful in vivo demonstration of efficacy in Phase I by (i) optimizing the production of JP4-039-MLV nanoparticles to transition to GMP manufacturing; (ii) characterizing the pharmacokinetics of JP4-039-MLV nanoparticles; and, (iii) demonstrating the efficacy of JP4-039-MLV radioprotection in a murine model exposed to an ARS-inducing dose (LD70/30) of whole-body irradiation. In addition, ChromoLogic will prepare and FDA regulatory plan.