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VivaGel(R) Demonstrates Efficacy in Bacterial Vaginosis
Date:5/23/2011

SYDNEY, May 23, 2011 /PRNewswire/ -- Starpharma Holdings Limited (ASX: SPL, OTCQX: SPHRY) today announced successful results of a major phase 2 clinical study that demonstrated efficacy of VivaGel(R) for the treatment of bacterial vaginosis (BV).

Key Points:

  • VivaGel(R) meets primary endpoint, demonstrating significant efficacy for treatment of BV
  • VivaGel(R) expected to avoid many shortcomings of existing therapies
  • Trial results support new patent filing which extends VivaGel(R) protection to at least 2032
  • Planning underway for Phase 3 trials for VivaGel(R) for BV treatment
  • BV prevention trial of VivaGel(R) to commence Q3 2011
  • Addressable global market for BV treatment and prevention potentially exceeds $1B

VivaGel(R) meets primary endpoint, demonstrating significant efficacy for treatment of BV

The study showed that treatment with VivaGel(R) (containing 1% of the active, SPL7013), once daily for seven days, resulted in 74% of patients achieving Clinical Cure of BV 2 to 5 days after completion of therapy compared with just 22% in the placebo group (P=0.0002).

Moreover, 2 to 3 weeks after completion of therapy, 46% of patients achieved Clinical Cure of BV compared with just 12% for the placebo (P=0.006) indicating that VivaGel(R) provided lasting cure in a significant proportion of the women. Both results were highly statistically significant and cure at both time points is considered by clinicians to be important in the clinical management of BV.

The main symptoms of BV are unpleasant vaginal discharge and odour. In Starpharma's study, vaginal BV discharge as assessed by the investigator was cured following treatment in 89% of the VivaGel(R) treated patients. Unpleasant vaginal odour was cured in 78% of the VivaGel(R) treated patients.

Dr Jackie Fairley, Chief Executive Officer of Starpharma, said: "Starpharma's objective is to d
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SOURCE Starpharma
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