Starpharma pleased with early trial results

Starpharma (ASX:SPL) has reported preliminary results from the Phase I clinical trial on its dendrimer-based vaginal microbicide indicate no adverse effects from the product in any of the women taking part in the trial.

The lead investigator on the study, Royal Adelaide Hospital's Dr John O'Loughlin, said he was confident that none of the subjects in the study suffered any untoward consequences from exposure to VivaGel.

"This preliminary finding is terrific news for Starpharma. There is no doubt that it is the most significant step to-date in our clinical development program for VivaGel," said Starpharma CEO John Raff.

The full results will be released once the company has completed its analysis early in 2005. In addition to the already completed gynaecological examination by colposcopy, which was used to evaluate vaginal and cervical irritation, the amount of the active compound entering the bloodstream and changes to the normal vaginal microflora will be assessed.

Raff said the results meant that the company could begin planning for future trials.

"On this basis, we anticipate that we will be able to proceed to the next steps in our clinical program with the objective of efficacy studies for the prevention of HIV and other sexually transmitted diseases," he said.

The company has a series of strategies in place to take the project forward including its recently announced involvement in an NIH-funded consortium to develop a second generation microbicide combining Starpharma's dendrimers with US company ReProtect's pH-balanced microbicide BufferGel. The consortium also includes research groups from the Johns Hopkins University, the University of Texas Medical Branch, the University of Kentucky, the University of Washington and Melbourne's Burnet Institute.

Other options for going forward include filing INDs with the FDA to test the use of VivaGel for prevention of herpes and chlamydia, both demonstrated in pre-clinical animal studies, and further HIV prevention studies with the backing of international governments in countries with serious HIV public health concerns.

"We want to back all the horses if we can. But if we have to fund it ourselves, we'll go with herpes initially," Raff said.

The company will work closely with the FDA to determine what further studies, if any, would be required before Phase II trials for herpes prevention could begin, he said.