Starpharma Presents Positive Results of Clinical Study of VivaGel in Men at 4th International AIDS Society Conference
MELBOURNE, July 24, 2007 /PRNewswire-FirstCall/ -- Starpharma Holdings Limited will today present results of a clinical trial indicating that 3% SPL7013 Gel (VivaGel(TM)) was well-tolerated in men, and suitable for further development as a topical microbicide for the prevention of HIV and genital herpes.
The results are to be presented by Starpharma in Sydney today at the 4th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention, at which the research and development of microbicides is a key focus.
The study compared 36 circumcised and uncircumcised men who applied VivaGel(TM) (24 men) or a placebo gel (12 men) topically to their penis once daily for seven days. The trial was double blinded so that the participants, principal investigator and study staff did not know who was receiving placebo or VivaGel(TM).
Overall, this study demonstrated that VivaGel(TM) was safe and well tolerated, and comparable with placebo when applied to the penis of both circumcised and uncircumcised healthy male volunteers once daily for seven days, and left in place for approximately 9 hours. As seen in a previous completed clinical trial in women, there was no evidence of absorption of the active ingredient of VivaGel(TM), SPL7013, into the blood after topical application.
The most commonly reported genital adverse events in both treatment groups were considered to be mild and to be consistent with application to the surface of the penis of a substance which dries and is not washed off for a number of hours.
Acceptability was a secondary endpoint in this study and interviews indicated that VivaGel(TM) would be acceptable to participants if shown to be protective against sexually transmitted infections, and there were few concerns around the potential impact on sexual pleasure.
A link to detailed results of the study is in the Appendix to this announcement.
The clinical study was conducted at the Melbourne Sexual Health Centre, in collaboration with the Burnet Institute and the National Centre in HIV Epidemiology and Clinical Research, and was funded with U.S. Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Department of Health and Human Services (Contract No. HHSN266200500042C).
VivaGel(TM) is being developed as a topical vaginal microbicide for the prevention of HIV and genital herpes, and is currently under investigation in healthy female volunteers in two separate expanded safety clinical trials at four sites in the U.S. and Kenya. VivaGel(TM) also shows promise as a contraceptive agent.
Potential as a condom coating
VivaGel(TM) is also being explored as a condom coating following the recent signing of an agreement with a leading international condom company.
The agreement includes a program of evaluation and development and also commercialisation rights covering condoms with VivaGel(TM) coatings within a specified geographical region. The condom company, whose name may not be disclosed for reasons of confidentiality, holds the leading market position within that region. The market in question is in the developed world, and ranks within the top five globally, measured by GDP.
The terms of the agreement were not disclosed.
Posted: July 2007
