Starpharma Holdings Limited announced the start of its next clinical trial of VivaGel. The study will measure the level of antiviral activity retained by VivaGel after vaginal administration. Assessment will be by laboratory assay of vaginal samples collected up to 24 hours after VivaGel application. The study in 12 women will determine the timescale over which VivaGel retains activity against HIV and HSV-2 (genital herpes).
"The value of this short trial is that it provides a potential surrogate for antiviral efficacy of VivaGel in humans ahead of phase-3 studies," said Dr Jackie Fairley, chief executive officer of Starpharma. "It will also give an indication of just how long before sex you could apply VivaGel to prevent infection," added Dr Fairley.
The study is being conducted at the Centre for Clinical Studies in Melbourne and is funded by the US National Institutes of Health (NIH).
VivaGel is being developed as a vaginal microbicide for the prevention of HIV and HSV-2. Other applications of VivaGel are also under assessment, including prevention of human papillomavirus (HPV), contraception and treatment of bacterial vaginosis (BV).
Starpharma Holdings Limited is a world leader in the development of dendrimer nanotechnology for pharmaceutical, life-science and other applications. Starpharma Pty Ltd (SPL) is principally composed of two operating companies, SPL in Melbourne, Australia and Dendritic Nanotechnologies, Inc in Michigan, USA.