PURIFICATION, REFORMULATION AND PHARMACOKINETICS OF NITROSYLCO

Oncology remains a major market of unmet need. BNOAT Oncology¿s long-term objective is New Drug Approval of its lead candidate nitrosylcobalamin, a tumor-specific, apoptosis-inducing, anti-cancer drug. Research Design and Methods: Nitrosylcobalamin purification will include crystallizations, various chromatographic techniques including basic ion-exchange resins, neutral ion exchange, gel filtration chromatography, and size exclusion chromatography. Proprietary formulation design algorithms and phospholipid gel (PG) depot formulation templates will be used in the development of the intravenous-depot formulation and the oral formulation. A variety of excipients will be used to design test formulations for their ability to achieve an optimized PK profile and work independently of intrinsic factor and/or vitamin B12 levels in the gut. Anticipated Results: A PG Depot formulation with a duration of release over a time course of 3-7 days in addition to an oral delivery independent of cobalamin metabolism. Purity (98%) of nitrosylcobalamin as determined by HPLC analysis.