Melbourne, Australia: Starpharma Holdings Ltd (ASX:SPL;OTCQX: SPHRY) today announced completion of recruitment in its two Phase 3 trials investigating VivaGel^® as a treatment for bacterial vaginosis (BV).

The Phase 3 treatment trials were conducted across more than 30 international sites, and recruited 250 patients per trial. The results of the trials are expected to be available by early December 2012 - following the completion of patient follow-up, data collection and the necessary statistical analyses.

These double-blind Phase 3 studies are the subject of a formal agreement with FDA under the Special Protocol Assessment (SPA) program, which confirms that the trial design, clinical endpoints and statistical analyses are acceptable for FDA approval once complete. 

Recruitment is also complete for Starpharma’s Phase 2 study for the prevention of BV recurrence.  Completion of this trial is on track for Q4 2012 with results expected early in 2013.

In the meantime, an active dialogue continues with a number of potential licensing partners as do activities to support an NDA and other regulatory submissions.  The required manufacturing validation and scale up activities are also now complete.

BV is the most common vaginal infection worldwide and is particularly prevalent in the US, where it affects an estimated one-third of the adult female population. Studies indicate as many as 50-60% of those women have recurrent episodes of BV and with no treatments currently approved for the prevention of recurrence of BV, that market is estimated to be in excess of $1 billion. In addition, existing treatments for BV are considered suboptimal with relatively low cure rates and high rates of recurrence, unpleasant side-effects, and high levels of bacterial resistance. 

VivaGel^® is a non-antibiotic gel that is not absorbed into the bloodstream (as antibiotics are), and as such it is not associated with the problematic side effects of antibiotics.  Clinical trials of VivaGel^® show a high level of patient acceptability and research with clinicians and patients indicate significant unmet need in the management of this disease.

Download ASX Announcement: VivaGel^® BV Phase 3 trials - recruitment complete ( pdf file, 125kb)