Starpharma to launch clinical trials for HIV gel

Starpharma has been given the all-clear from the US FDA to begin clinical trials on their dendrimer-based microcidal gel for prevention of HIV infection.

It's a major milestone for the Melbourne-based company, as it is the first time a dendrimer-based nano-drug has been given the go-ahead by the FDA. But the company has received a lot of support from the US National Institutes of Health, which has funded several crucial pre-clinical studies.

"It is the first defined nano-structure to go through the FDA -- that means a lot of work in terms of pre-clinical analytical work and proof," said CEO Dr John Raff. "We're relieved and delighted -- it couldn't be better from our point of view."

The microcidal vaginal gel -- VivaGel -- was recently shown in pre-clinical animal studies performed by Dr Che-Chung Tsai of the University of Washington in Seattle to prevent transmission of the monkey version of HIV in macaques. It has also been shown to prevent infection by genital herpes and chlamydia in animal studies.

Raff said the Phase I clinical trial for VivaGel would be performed in Australia through the Institute of Drug Technology's clinical trials unit CMAX, in South Australia. Although local ethics committee approval would be required before the trial could start, he said the trial would probably be underway before the end of the year.

The trial would specifically look at safety aspects, including absorption of the drug and whether it causes inflammation, over a two-week period of daily administration, Raff said.

Starpharma hopes to partner with a pharmaceutical company for large-scale Phase II/III studies once the Phase I studies have been completed.

Raff expects that the clearance of the dendrimer-based microcidal gel will open up new opportunities for Starpharma to work with pharmaceutical companies in a range of areas. "There are opportunities for partnerships with pharmaceutical companies to make existing drugs into polyvalent compounds," he said.

Polyvalency is becoming increasingly of interest to drug developers, as polyvalent compounds often show significantly more activity than monovalent drugs. Converting a drug to a polyvalent form may also allow a company to extend the life of a patent.