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news.BTG has completed patient enrolment and treatment in its US-based Phase II clinical trial of BGC20-0582 for the treatment of head lice infestation. The company expects to have data from this trial in early 2008.
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The Phase II trial, which enrolled 225 subjects, is a randomized, double-blind, placebo controlled trial evaluating the safety and efficacy of BGC20-0582 in subjects infested with head lice. The primary endpoint for the study is clinical cure, defined as absence of live lice fourteen days following treatment. The current Phase II trial followed extensive in vitro laboratory investigation of BGC20-0582.
Russell Hagan, head of R&D at BTG, said: “Data from this study will enhance our understanding of BGC20-0582 as a potential treatment of head lice infestation and shape future development and commercial options for the product.”