May 11 2008
Starpharma Holdings Limited today announced positive results of a clinical trial that achieved all its objectives demonstrating that 3% SPL7013 Gel (VivaGel) was safe and well-tolerated in sexually abstinent women when administered vaginally, twice daily for 14 days.
Based on these results and existing supporting data, the product is deemed suitable for continued development as a topical microbicide for the prevention of HIV and genital herpes (HSV) and the exploration of other potential indications. These findings support current and future clinical studies to assess the safety and efficacy of VivaGel for genital herpes and HIV in sexually active women.
The study enrolled 54 women in the U.S. and Kenya and was double blinded so that the participants, the investigators and study staff did not know who was receiving VivaGel or placebo gel.
Blood tests (systemic laboratory parameters) showed no evidence of any treatment-related effects in study participants. This finding was not surprising, given that consistent with previous clinical and non-clinical studies, there was no evidence of absorption of the active ingredient of VivaGel, SPL7013, into the blood after vaginal application in this study. Study participants also showed no evidence of any treatment-related effects on vaginal microflora.
No participant discontinued or was required to discontinue product use due to any adverse events during the trial.
An additional positive outcome was there was no statistical difference between the VivaGel and placebo arms in the number of participants who experienced any sign or symptom including genitourinary (genital and urinary) signs or symptoms deemed to be associated with product use. During the study, there were no serious adverse events reported, nor grade 3 or 4 adverse events. Moderate (grade 2) genitourinary findings occurred in only three women receiving VivaGel at the U.S. site. All other genitourinary findings were reported as being mild (grade 1).
The incidence of genital signs and symptoms reported with VivaGel in this study is in line with that reported for other topical vaginal products and markedly lower than that reported with nonoxynol-9 in similar studies.
Starpharma's CEO, Dr Jackie Fairley said, "We are pleased to report that VivaGel has met its safety and tolerability endpoints in this expanded safety study. We look forward to moving ahead with further trials of the product - both in the HIV and HSV-2 programs and also potentially in additional applications of VivaGel including other STIs and contraception."
The clinical study was funded by the Division of Microbiology and Infectious Diseases (DMID), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) and conducted by DMID in collaboration with the Sexually Transmitted Infections Clinical Trials Group (STI-CTG). This was the first study to be conducted under the U.S. Investigational New Drug application (IND) for VivaGel for prevention of genital herpes.
A summary of the results of the study is included in the Appendix to this announcement.
VivaGel is being developed as a topical vaginal microbicide for the prevention of HIV and genital herpes, and also shows promise as a contraceptive agent. In addition, the company recently reported VivaGel has activity against clinically relevant human papillomavirus (HPV). Starpharma is also co-developing a VivaGel coated condom with SSL International plc and one other unnamed market leading condom company.
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