Melbourne, Australia -- Starpharma Holdings Ltd (ASX:SPL, OTCQX: SPHRY) is pleased to report excellent progress in the recruitment for its pivotal Phase 3 trials for VivaGel® as a treatment for bacterial vaginosis (BV).
Two concurrent Phase 3 trials are underway and recruitment for these trials, which commenced in late March 2012, has recently passed the halfway mark with 60% of patients already enrolled. One of the trials has already exceeded 80% enrolment.
The Phase 3 treatment trials are taking place across more than 30 international sites, primarily in the United States. Following the completion of the Phase 3 trials Starpharma expects to prepare and submit a New Drug Application (NDA) to the US Food and Drug Administration (FDA) in parallel with engaging in licensing negotiations. The FDA has already provided formal agreement as part of a Special Protocol Assessment (SPA) declaring that the phase 3 trials' design, clinical endpoints and statistical analyses are acceptable for FDA approval once completed.
"We are extremely pleased with the rate of enrolment for the pivotal Phase 3 trials underway. We are already approaching two thirds enrolment in less than three months, which means we are well on track to complete and report the trials in 2012 as indicated," said Dr Jackie Fairley, Chief Executive Officer of Starpharma.
BV is the most common vaginal infection worldwide, and the most common cause of vaginal irritation, discharge and malodour. It is particularly prevalent in the US, where it affects an estimated one-third of the adult female population. BV is often implicated in pelvic inflammatory disease and may also be associated with pre-term birth and an increased risk of sexually transmitted infections, including HIV.
"Completion of these Phase 3 trials is a very important milestone for Starpharma as it is the precursor to seeking regulatory approval for VivaGel® as a treatment for BV," Dr Fairley said.
The market for topical treatments of BV is estimated at US$300-$350 million. However, existing conventional antibiotic treatments 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 applied to the vagina with an applicator. VivaGel® is not absorbed into the bloodstream (as antibiotics are), and as such it is not associated with the side effects of antibiotics. Clinical trials of VivaGel® have shown a high level of patient acceptability.
Details of the Phase 3 trial design are contained in the announcement of the trial commencement made on 22 March 2012 available at www.starpharma.com/asx_announcements