Starpharma gets gel trial nod

Dendrimer nanotechnology company Starpharma has submitted an Investigational New Drug (IND) application to the FDA for Phase I clinical trials on its SPL7013 vaginal microbicide gel.

Initial application for FDA approval will be for an HIV preventative, but Starpharma has high hopes for the product as an active agent against chlamydia and genital herpes. Vaginal microbicides such as SPL7013 act by stopping the STDs adhering to the epithelial cells and killing them before they have a chance to enter the body and spread into the circulation.

“We have submitted the application, and now we will wait for the thirty days before we can start running trials,” said Starpharma company secretary Ben Rogers.

“We are starting to plan the trials in anticipation – but just submitting the application has been a major achievement, as this was the first that indicated a dendrimer in a pharmaceutical situation,” he said.

Rogers said the application had also set some precedents in the way the test protocols, quality assurance and regulatory issues were approached by the company. He noted that five cartons of documents were required to complete the application process alone.

“Nobody had ever done this before, so we had to do a lot of work, and we developed all the necessary expertise in-house. This capability will definitely help us in future though, as next time we won’t have to start from scratch with the whole application process,” he said.

In the light of escalating STD (sexually transmitted disease) rates, Starpharma initiated a research program in 1999 to develop dendrimers as topical vaginal microbicides. Preclinical evaluation of the polyvalent compounds indicated broad-spectrum activity against HSV, HIV, HPV and HBV in vitro and in animal model of genital herpes.

As yet, there are no similar commercially-available products in the field.