BTG Completes Enrolment of Phase II Clinical Trial of BGC20-0582 for Head Lice Infestation
London, UK and West Conshohocken, PA, US, 13 December 2007
– BTG (LSE: BGC), the life sciences company, reported today that it 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.
"The completion of enrolment of this US Phase II trial is an important milestone. 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," said Russell Hagan, Head of R&D at BTG.
The Phase II trial, which enrolled 225 subjects, is a randomised, 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. Terri Meinking, a recognised world authority on head lice and the development of medicines to treat head lice infestation, who was involved in these laboratory studies, commented that "BGC20-0582 represents an exciting new development as new products for the treatment of head lice infestation are needed. Drug resistance has become an issue and this new product appears to have multiple mechanisms of action that result in strong pediculicidal and ovicidal effects."
BGC20-0582 is a non-pesticidal product derived from a natural source. BTG has developed a proprietary gel-based formulation for use as a topical treatment of head lice infestation. In laboratory studies, BGC20-0582 killed both lice and their eggs following very short treatment times and was shown to be superior to a leading over-the-counter lice treatment product. BGC20-0582 appears to work through multiple mechanisms of action that are distinct from those associated with the currently available lice treatment products, most of which are pesticide based. These unique modes of action predict that BGC20-0582 will not be susceptible to drug resistance that is increasingly limiting the effectiveness of currently marketed lice treatment products.
About Head Lice
Head lice are parasites, Pediculus humanus capitis, which feed on the human scalp and lay eggs on the hair. Head lice are spread by head-to-head contact and infestation is most common among children in childcare centres and schools. Head lice infestation causes intense scalp itching and irritation. The annual incidence of head lice infestation in the United States is between six and twelve million with the majority of those infested being school age children. This incidence of infestation results in an estimated 12 to 24 million missed school days per year. In developing countries it is estimated that over 50 per cent of the general population may be infested. The American Academy of Pediatrics has provided guidelines that strongly recommend the use of currently available over-the-counter treatments as first line treatment for head lice infestation. However, many of these over-the-counter therapies are increasingly being recognised as limited treatment options because of the emergence of lice resistance.
BTG in-licenses, develops and commercialises pharmaceuticals principally in the areas of neuroscience and oncology. The company has a substantial and growing revenue stream of royalties from out-licensed products and a broad, expanding internal pipeline of development programmes. BTG operates from offices in London, Philadelphia and Osaka. For further information, visit: www.btgplc.com.
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