Starpharma STD gel in US tests

The US government is paying for tests of a Melbourne-developed microbicide gel on macaque monkeys.

The gel, developed by Starpharma, has been designed as a topical vaginal prophylactic treatment against sexually transmitted disease.

The National Institutes of Health (NIH) has announced that it will fully fund two studies to test the effectiveness of the gel against the transmission of HIV/SIV, or humanised subgenus immunodeficiency virus, and chlamydia in the animals.

The gel contains a compound known as SPL7013 and is intended for use by women before sex to prevent STD transmission.

Starpharma also announced that it was preparing an Investigational New Drug application to the FDA seeking approval to test the gel on humans in a phase I trial.

The company said that, if approved, this would mark the first time a dendrimer-based nanostructure had been allowed for use in humans.

CEO Dr John Raff said the animal studies were needed in the lead-up to phase II/III population studies, but were not required for the phase I trial.

He said about 36 specially-bred monkeys would be used in the two trials and while he would not say how much the NIH had committed to the project, Raff said most trials involving monkeys cost about $50,000 per animal excluding follow-up pathology.

Monkeys for the chlamydia trial have already been recruited, with the study expected to begin within a month.

The HIV/SIV trial was set to begin about June, with both studies anticipated to last about a month.

In keeping with NIH-sponsored trial requirements, Starpharma said it had demonstrated efficacy of the compound against HIV, herpes, hepatitis B and chlamydia in cell-based and smaller animal studies.

It said the results of the cell-based studies and an update on the compound's development would be presented in full at the Microbicides 2002 conference in Antwerp, Belgium from 12-15 May and at the meeting of the Australasian College of Sexual Health Physicians in Perth, from 29 May to 1 June.

Starpharma is a wholly-owned subsidiary of Starpharma Pooled Development Fund (ASX: SPL), which recently established a joint venture with US company Dendritic Nanotechnologies.

The vaginal microbicide work is being done in collaboration with the University of Queensland, Belgium's REGA Medical Research Institute, the University of Texas and University Medical Centre, Ohio.