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

evelop an efficacious BV product that avoids the side-effects and other shortcomings of conventional antibiotics."

"This Phase 2 study was a crucial test of the product and these exciting results confirm the significant commercial potential of VivaGel(R) for BV. As well as the great outcome for the acute treatment opportunity, we are also very encouraged by the implication of these results for the additional application of VivaGel(R) for prevention of BV recurrence."

"It is particularly pleasing to see such high rates of resolution of symptoms and excellent patient acceptability", she said.

Existing treatments for BV, such as the conventional antibiotics metronidazole and clindamycin, have published Clinical Cure rates of between 35% and 65% when assessed 2-3 weeks after completion of therapy. Unfortunately, existing products have significant shortcomings in terms of side-effects or tolerability, high levels of antibiotic resistance and in some cases incompatibility with condoms.

In contrast, whist having comparable efficacy, VivaGel(R) is well tolerated, is not absorbed (and so is free from systemic effects), can be used with condoms, and has the real potential to be used for prolonged periods to prevent recurrence of BV.

Clinical Cure 2 to 3 weeks after completion of treatment is currently the US FDA's preferred endpoint for assessing cure of BV.  In addition to cure of BV achieved with VivaGel(R) at that time, acceptability of the product was very high with 83% of patients using 1% VivaGel(R) extremely satisfied, very satisfied or satisfied with the product when taking all aspects of the treatment into account, compared with just 35% of patients using the placebo.

Professor George Kinghorn, of the Department of Genitourinary Medicine at the Royal Hallamshire Hospital, Sheffield, UK, a leading expert in BV and Medical Advisor to Starpharma on this Phase 2 study, commented: "These significant efficacy results are very
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SOURCE Starpharma
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