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Antimicrobial Agents and Chemotherapy, May 2006, p. 1696-1700, Vol. 50, No. 5
0066-4804/06/$08.00+0     doi:10.1128/AAC.50.5.1696-1700.2006
Copyright © 2006, American Society for Microbiology. All Rights Reserved.

Preclinical Safety and Efficacy Assessments of Dendrimer-Based (SPL7013) Microbicide Gel Formulations in a Nonhuman Primate Model

University of Washington, Seattle, Washington,¹ Starpharma Pty Limited, Melbourne, Australia,² Magee-Womens Hospital, University of Pittsburgh, Pittsburgh, Pennsylvania³

Received 22 September 2005/ Returned for modification 30 January 2006/ Accepted 11 February 2006

Three gel formulations (1%, 3%, and 5% [wt/wt]) of SPL7013, a dendrimer known to have antiviral (anti-human immunodeficiency virus and anti-herpes simplex virus) activities, completed a range of preclinical tests in the pigtailed macaque models for vaginally and rectally applied topical microbicide safety assessments. The vaginal safety profile of the 3% SPL7013 gel formulation was equal to that of the 1% formulation but was superior to that of the 5% formulation. The 3% SPL7013 gel was further evaluated for rectal safety and for antichlamydial efficacy with cervical challenge with Chlamydia trachomatis. This first-generation dendrimer-based product was shown to be safe to the vaginal and rectal microenvironments with repeated daily use. However, a single intravaginal application of the 3% (wt/wt) SPL7013 gel did not provide protection from the acquisition of cervical chlamydial infection.