Clinical Studies with Liposomal Doxorubicin

Abstract

To present data on a continuing phase I study of liposomal doxorubicin at this time may seem like a giant leap backwards. Liposomally encapsulated doxorubicin has been available for clinical use for some years. Phase I studies have been completed, and phase II studies have been conducted in patients with breast cancer (1,2). Two major obstacles to the commercial exploitation of drugs encapsulated in liposomes were evident. the first was to find a preparation that could be given safely to humans. the second was to develop a pharmaceutical preparation that could be commercially exploited by fulfilling the requirements for manufacture and sale as a drug. the first of these problems was solved a number of years ago, but only recently have we had preparations that fulfilled the second requirement. Two of these have entered clinical trials at Roswell Park Memorial Institute (RPMI). One of these, the liposomally encapsulated muramyl tripeptide derivative (MTP-PE), has been presented previously (3,4). Accordingly, in this paper we will focus on our studies of liposomally encapsulated doxorubicin.