BV treatment: full enrolment for phase 2 and first phase 3 trial

Starpharma Holdings Ltd (ASX:SPL; OTCQX: SPHRY) is pleased to report that recruitment is now 100% complete for its Phase 2 clinical trial to investigate the ability of VivaGel^® to prevent the recurrence of BV, and also for the first of two pivotal Phase 3 studies of VivaGel^® for the treatment of BV.

The Phase 2 prevention study is being conducted under an investigational new drug application (IND) and has enrolled 205 patients with a prior history of recurrent BV. The trial is being conducted across multiple sites in the US.  The primary objective of the study is to determine the efficacy of two strengths of VivaGel^® (containing 1% or 3% SPL7013) compared with a placebo gel in preventing recurrence of BV.  The product is used every second day over a period of 16 weeks.

“The high rates of recurrence of bacterial vaginosis reported by clinicians and their patients are driving significant demand for an effective approach to prevent the recurrence of this condition.  BV has a significant impact on the quality of life of women who suffer chronic bouts, but worse, can lead to more serious reproductive and sexual health complications,” said Dr Jackie Fairley, Starpharma Chief Executive Officer.

Further to the Company’s announcement on 4 June 2012, which provided a progress report on recruitment, Starpharma is pleased to advise that the first of its two Phase 3 studies has also now completed recruitment with 250 patients enrolled.  These Phase 3 studies of VivaGel^® as a treatment for BV 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.  The two Phase 3 trials and the Phase 2 trial for prevention of recurrence are all expected to complete in 2H CY2012.

Furthermore, as well as the excellent clinical trial progress, Starpharma is pleased to report that the other activities to support its proposed new drug application (NDA) submission for VivaGel^® for the treatment of BV, which will follow soon after the announcement of Phase 3 trial results, are well advanced.

To support product launch and marketing volumes, Starpharma has already completed full scale up of the VivaGel^® active ingredient, SPL7013, to the tens of kilograms scale under full good manufacturing practices (cGMP) at an FDA and EU-certified manufacturer that supplies marketed pharmaceutical actives globally.  Scale up of the finished product to the multiple hundreds of kilograms scale has also been achieved and planning of final process validation, which will follow after submission of an NDA, is well advanced.

As previously reported, the nonclinical toxicology program for VivaGel^® is already complete to support the NDA submission.

These achievements and activities are all aimed at expediting the approval and launch process.

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 and up to 50% of the female population in some regions.  Studies indicate as many as 50-60% of those women have recurrent episodes of BV. (1)

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.  There are no treatments currently on market for the prevention of recurrence of BV; however the market is estimated to be in excess of $1 billion.

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^® show a high level of patient acceptability.

(1)  (Marrazzo, 2011; Bradshaw et al, 2006)