Dendrimers As Drugs: Discovery, Preclinical and Clinical Development of SPL7013 Gel (VivaGel™), a Dendrimer Based Microbicide for HIVand STI Prevention

Starpharma focuses on the use of dendrimers as drugs in their own right – in contrast to dendrimers as drug delivery vehicles or diagnostics. Dendrimers offer a unique platform for exploring chemical diversity on the nanoscale and the production of dendrimer libraries covering a diverse array of macromolecular structures can be used in drug discovery and development. One pharmaceutical application of dendrimers that Starpharma is pursuing is the development of microbicides for the prevention of HIV and sexually transmitted infections (STIs). This presentation will describe the dendrimer drug discovery and lead candidate selection process from which SPL7013 emerged as a microbicide development candidate. Pivotal preclinical data will be presented that lead to Starpharma submitting an Investigational New Drug application (IND) for SPL7013 gel (VivaGel™) to the United States Food and Drug Administration (FDA) in June 2003, the first such submission for a dendrimer based drug. Finally, results of the first clinical trial under this IND will presented.