Melbourne, Australia; Starpharma Holdings Limited (ASX:SPL, OTCQX:SPHRY) today announced it had completed enrolment and all patient follow-up visits in its phase 2 study of VivaGel^® for the treatment of bacterial vaginosis (BV). 

This study investigated the effectiveness of VivaGel^® administered once daily for seven days in the treatment of BV and enrolled 132 participants in the US.  Data is now being processed and results will be available in the second quarter of this year.

BV is the most common vaginal infection worldwide, and the most common cause of vaginal irritation, discharge and malodor.  It is particularly prevalent in the US, where it affects an estimated one-third of the adult female population.  The condition is implicated in pelvic inflammatory disease and may also be associated with an increased risk of sexually transmitted infections, including HIV, and pre-term birth.

BV is characterised by frequent recurrence, with some women experiencing it as many as three or more times a year.  Current therapies are generally considered by clinicians to be inadequate, and lasting cure is rare and difficult to achieve.  There are also few real options for women to address frequent recurrence of the condition.  Existing antibiotic treatments are not considered suitable for frequent or long-term use.

Dr Jackie Fairley, Chief Executive Officer of Starpharma, said: "The completion of this study represents an important milestone in the development of VivaGel^®.  The global market for topical BV treatments alone is estimated to be approximately US$300-350M per year, while the market for a product to prevent BV recurrence is estimated to be significantly larger than the acute treatment market.  Therefore, we look forward to the results of this trial, as well as progressing studies for prevention of BV.  The low risk of side effects and other features, such as condom compatibility, make VivaGel^® particularly well suited for both treatment and prevention of BV.”

Therefore, as well as the current study for investigation of VivaGel^® as an alternate to antibiotics for short term treatment of BV, Starpharma also plans within the next two to three months to initiate a second phase 2 study to assess the ability of VivaGel^® to prevent recurrence of BV.  Planning for this study is already well advanced with CRO and site selection processes well underway.  

The following table summarises the Phase 2 trial program and commercial opportunities for the use of VivaGel^® in BV:

Download ASX Announcement: Completes enrolment for Phase 2 study of VivaGel for BV ( pdf file, 149kb)