We propose to develop monoclonal antibody targeted liposomes for the purpose of delivering chemotherapeutic agents. Monoclonal antibody raised against a tumor specific surface antigen will be covalently coupled to the liposome surface. The linking chemistry to be used has been developed at Vestar to suit scale-up pharmaceutical production. The liposome formulation will have an anthracycline dissolved in the liposomal membrane or entrapped in the aqueous interior of the liposome. Efficacy will be determined in vitro using a tissue culture assay. Emphasis will be placed upon scaleable formulations and manufacture protocols in the targeted liposome design. Demonstration of in vitro efficacy using Vestar's patented technology will constitute application for Phase II in which emphasis will be placed on in vivo efficacy and characterization with respect to pharmacology and toxicology of the liposomes. The ultimate goal is to develop a product which targets cytotoxic agents specifically to tumors in a fashion that is far to superior to free drug or non-targeted liposomal drug.
