Self-Assembling System for Targeted Nanodelivery of Proteins (STOP)

Providing improved countermeasures to protect military personnel and the civilian population from biological warfare agents is an extremely high priority need. For example, there is currently no effective treatment beyond the difficult to control and implement administration of antibiotics shortly after exposure to inhalation anthrax, one of the more likely biological attack scenarios. Although new prophylactic and therapeutic anti-anthrax monoclonal antibody remedies are under accelerated development, none currently provide closely controlled release of the antibody without significant loss of activity. Clearly there is an urgent need for parallel development of new drug delivery technologies that can be preventively administered and released, as needed, to targeted sites. In a recently completed Phase I program Infoscitex and their teaming partner, a university medical center, demonstrated the feasibility of a controlled release drug delivery system. This nano-scaled activity (protein) preserving delivery system is fully water soluble, biodegradable, non-toxic, biocompatible and non-immunogenic. In this proposed Phase II program Infoscitex and its teaming partners will focus on optimizing capacity and control of drug release from the novel protein carrier structure using improved block-copolymer assembly techniques. In vivo testing with anthrax antibody will lead to eventual clinical trials during Phase III.