Radioprotection by JP4-039-MLV nanoparticle drugs

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.