Starpharma Holdings Limited (ASX:SPL) today released full human clinical trial results indicating that VivaGel (SPL7013 gel) has a suitable safety profile to be developed as a vaginal microbicide for the prevention of HIV.
The unblinded data confirm and extend the findings of Starpharma’s preliminary announcement issued on November 17, 2004 that initial results of the Phase 1 study were positive. VivaGel caused no irritation, inflammation or other significant adverse effect. In pharmaceutical industry terminology, VivaGel was considered "safe and well-tolerated."
The Phase 1 study compared 36 women who received either various intra-vaginal doses of VivaGel or a placebo gel daily for one week. The trial was double blinded so that the volunteers, principal investigator and Starpharma did not know who was receiving placebo or VivaGel. Study participants were assessed by a gynaecologist for possible irritant effects of the gel. Additionally, the women were assessed for any possible effect upon vaginal microflora (natural micro-organisms in the vagina) or absorption into the blood of the active ingredient of VivaGel.
"Based upon our thorough review of the complete data, VivaGel appears to be a very safe and gentle product for intravaginal use by women," stated the Principal Investigator on the study, Dr John O’Loughlin of the Royal Adelaide Hospital. "There is no evidence to indicate that VivaGel caused any irritation or inflammation whatsoever."
VivaGel is being developed as a topical microbicide that has the potential to prevent the transmission of HIV and other STDs when applied to the vagina prior to sexual intercourse. In earlier studies performed in monkeys, VivaGel was found to be highly effective in preventing HIV transmission.
Dr John Raff, CEO of Starpharma, said: "We are delighted to receive this very positive data supporting the safety of VivaGel in humans. Combined with our earlier animal studies demonstrating the effectiveness of VivaGel as an HIV preventative agent, we believe that this data supports future larger-scale efficacy and safety clinical trials of the product. VivaGel is shaping up to become an important weapon in the battle against the HIV/AIDS epidemic."
The clinical trial was conducted at CMAX, a Division of IDT Australia Ltd, in Adelaide under an effective "Investigational New Drug" application filed with the US Food and Drug Administration (FDA). Starpharma’s VivaGel is the first drug product in the world based upon nanoscale molecules called dendrimers to enter human trials under FDA Regulations.
An expanded summary of the clinical trial results is included in the Appendix to this announcement.
