application): The overall objective of this Phase II STTR application is to complete the preclinical studies for NPC 1161B, a promising new drug candidate for the treatment and prophylaxis of malaria. The drug is also very effective in animal models for the treatment or prevention of Pneumonocysis carinii (PCP) and leshmaniasis. This project is the continuation of the STTR Phase I project and a continuing collaborative effort between Elsohly Laboratories Inc., Oxford MS and The National Center for Natural Products Research of the University of MS (UM). In this Phase II application, these studies will be extended to complete the package of information necessary for the filing of the Investigational New Drug application. The objective will be accomplished through a plan of work to achieve the following specific aims: 1) Determine the physiochemical characteristics purity and stability of the GMP drug substance NPC1161B, assess compatibility of the drug with commonly used capsule formation excipients; 2) Evaluate the stereoisomers of NPC1161 (NCP1161A and NCP1161B) in primate models for relative antimalarial efficacy, toxicity, and metabolism/kinetics; 3) Develop analytical methods and a formulation of NCP1161B for clinical studies (drug product) and conduct accelerated stability studies; 4) Prepare and submit IND application.
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