Starpharma wins $7.5 million NIH grant

Melbourne-based nanotechnology company Starpharma (ASX:SPL) has won a AUD$7.5 million (US$5.4 million) grant from the US National Institutes of Health to lead a consortium developing microbicides for the prevention of infection by HIV and other sexually transmitted diseases.

The consortium also includes US reproductive health company ReProtect - which has a vaginal microbicide in clinical trials-- together with research groups from the Johns Hopkins University, the University of Texas Medical Branch, the University of Kentucky, the University of Washington and the Burnet Institute in Melbourne.

Phase I clinical trails for Vivagel underway

Starpharma has started Phase I clinical trials of its microbicide gel, VivaGel, for the prevention of STDs, in particular HIV.

Starpharma's Tom McCarthy spoke about the dendrimer-based gels the company is developing at the Australian Microbiology conference yesterday.

"This vaginal microbicide is a prevention strategy for protecting the vaginal lumen from HIV," said McCarthy. "We are also looking at using it for other STDs, such as genital herpes and chlamydia."

The active component of the microbicide is a specifically designed dendrimer, a synthetic molecule generated by growing shells or layers around a core molecule.

Because dendrimers are synthetic, their size, 3-D shape, number and type of surface molecules can be tightly controlled, giving a molecular purity or homogeneity to mixes of these compounds.

VivaGel contains the SPL7013 dendrimer, which has napthalene disulphonic groups on its surface that prevent HIV binding to the vaginal epithelium, an event necessary for infection.

SPL7013 has proven itself in preventing the entry of HIV into cells in vitro as well as against clinical isolates of the virus.

"We have been working with the Burnet Institute in Melbourne on clinical isolates of HIV, because really these are the ones you want to impede, and SPL7013 appears to be effective."

The vaginal gel has also been tested in female pig tailed macaques infected with the humanised form of the simian immunodeficiency virus (SIV), and provided 100 per cent protection against SIV whereas those monkeys who were not given the gel all became infected.

VivaGel recently received clearance from the USFDA for human clinical trials. "We went down the USFDA process with SPL7013," said McCarthy. "It's not insurmountable for a small Australian biotech to go through."

Initial Phase 1 clinical trials in healthy human volunteers will begin Adelaide in collaboration with Helen McDonald, at the Women's and Children's Hospital, who will look at the effect of the gel on native vaginal flora.

"Once we have established the safety of the gel in humans, which we anticipate will be towards the beginning of 2005, we hope to expand the Phase I program in Australia and elsewhere in South East Asia and Subsaharan Africa," said McCarthy. "This will involve non-government and government organisations."