Dendrimers as Drugs: Discovery and Preclinical and Clinical Development of Dendrimer-Based Microbicides for HIV and STI Prevention

Autor: Mccarthy Thomas D, Graham P. Heery, Jeremy R.A. Paull, Scott Andrew Henderson, Barry Ross Matthews, David Francis O'keefe, Michael Giannis, George Holan, Peter Karellas
Rok vydání: 2005
Předmět:
Zdroj: Molecular Pharmaceutics. 2:312-318
ISSN: 1543-8392
1543-8384
DOI: 10.1021/mp050023q
Popis: Starpharma focuses on the use of dendrimers as drugs in their own right, in contrast to dendrimers as drug delivery vehicles or diagnostics. This contextual review describes how dendrimers offer a unique platform for exploring chemical diversity on the nanoscale and how the production of dendrimer libraries covering a diverse array of macromolecular structures can be used in drug discovery and development. Using Starpharma's work on the prevention of HIV and sexually transmitted infections (STIs) through the development of microbicide candidates as an example, the process from which SPL7013 emerged as a development candidate is described. Following a range of preclinical studies, Starpharma submitted 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. The first clinical trial under this IND was completed in 2004.
Databáze: OpenAIRE