Melbourne, July 9, 2008 AEST (ABN Newswire) - Starpharma Holdings Limited (ASX:SPL)(PINK:SPHRY) today announced that it will add the treatment of bacterial vaginosis (BV) to the development program for its vaginal microbicide VivaGel(R).
This is the first application of VivaGel(R) as a treatment. The existing applications are for prevention of infection by the sexually transmitted viruses that cause AIDS (HIV), genital herpes (HSV) and genital warts (HPV), or contraception.
Bacterial Vaginosis is characterised by an imbalance between the naturally occurring vaginal lactobacilli and disease-causing bacteria. It is a major cause of vaginal infection and is particularly prevalent in the US, where it is reported to affect 29% of women.** The condition is implicated in pelvic inflammatory disease and may also be associated with an increased risk of sexually transmitted infections and abortion.
Preliminary findings from Starpharma's recent clinical trials suggest that VivaGel(R) treatment tends to restore the normal balance of bacteria in women who had asymptomatic BV at the time of enrollment in the trial. (Women with symptomatic BV were excluded from the studies).
"This product application is of great interest to Starpharma because of its potential to open up a new, possibly rapid, path to market for VivaGel(R). We now plan to investigate these observations fully by conducting clinical trials designed specifically to examine VivaGel's efficacy in the treatment of BV," CEO Dr Jackie Fairley said.
The global market for topical vaginal treatments for BV is estimated to be around US$300 million with 4 million prescriptions annually for BV treatment in the US alone.
The current treatment of BV with conventional antibiotics may lead to the development of drug resistance, increased susceptibility to thrush (candidiasis), drug interactions and are incompatible with condoms.
If proven effective against BV, VivaGel(R) may offer several important advantages over current conventional antibiotic treatments: it is compatible with condoms and is not absorbed by the body, so is less likely to cause drug interactions or lead to drug resistance. In addition, many women experience recurrent BV and are unhappy about the need for continued administration of conventional antibiotics creating a need for alternative therapeutic approaches.
** Prevalence of Bacterial Vaginosis, Obstetrics and Gynecology, Vol. 109, No. 1, January 2007.
About bacterial vaginosis
BV, reportedly the most common vaginal infection, is a major contributor to the 10 million visits to medical practitioners each year in the US.
BV is commonly associated with a malodorous vaginal discharge and has been implicated in the development of pelvic inflammatory disease. Both symptomatic and asymptomatic BV may be associated with an increased risk of HIV infection and other sexually transmitted infections (chlamydia, gonorrhea and genital herpes), spontaneous abortion, and pre-term birth.
Contact
Dr Jackie Fairley
Chief Executive Officer
TEL: +61 3 8532 2704
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