STARPHARMA BEGINS TRIAL OF MICROBICIDE GEL

Starpharma has begun a Phase I safety trial in men for its lead product VivaGel (SPL7013). VivaGel is a microbicide for the prevention of the sexually transmitted infections, including genital herpes and HIV. It has already been successfully tested in a Phase I safety study in women.

The trial is being conducted to provide safety data for men who may be exposed to product by their female partners. The trial is fully funded as part of a $20.3 million grant from the National Institute of Allergy and Infectious Diseases, part of the NIH.

The randomized, double-blinded, placebo-controlled trial will assess the safety and pharmacokinetics of the gel in 36 healthy male volunteers when applied once a day for seven days.

Recruitment will begin immediately, and results are expected within two to three months of the last volunteer joining the study.