19th Jun 2006 07:00
BTG PLC19 June 2006 BTG to commence US phase II clinical safety study of Varisolve(R) London, UK, 19 June 2006: BTG plc (LSE: BGC), the medical innovations company,today announces that it intends to complete preparations for and commence a USphase II clinical safety study of Varisolve(R), the novel injectable microfoamtreatment for varicose veins. BTG's preferred strategy had been to partner the programme prior to commencing aUS phase II safety study. The Company now intends to move forward with thestudy, which it is able to fund from existing resources without impactingcurrent development activities in the broader BTG pipeline, in order to maintaindevelopment progress and to continue to build value in the product whilstcontinuing partnering discussions. Louise Makin, BTG's chief executive officer, commented: "We have decided toprogress this study so that we can maintain momentum and generate importantsafety data on Varisolve(R). We will in parallel continue to pursue allpartnering options for Varisolve(R), recognising that some potential partnersmay first want to see positive data emerging from the study." The phase II study will explore the safety of Varisolve(R) in 50 patients whohave a patent foramen ovale (PFO), a defect whereby the small hole that connectsthe right and left atria of the heart to improve foetal circulation does notclose at birth. PFOs are estimated to be present in approximately 20% of thepopulation. Under certain conditions, they allow blood (and potentially clots,particles or bubbles within the blood) to travel from the right atrium into theleft atrium, then out of the heart and into the arterial system. The study aimsto answer the US regulator's question as to whether the microbubbles inVarisolve(R) that cross through the PFO can cause sub-clinical effects in thebrain such as microinfarcts. Varisolve(R) has successfully completed a pivotal European Phase III trial inwhich 435 patients were treated with the product and followed up for one year. Ends ContactsBTG Financial DynamicsAndy Burrows, Director of Investor Relations Ben Atwell+44 (0)20 7575 1741 +44 (0)20 7831 3113Christine Soden, Chief Financial Officer+44 (0)20 7575 1591 About BTG BTG in-licenses, develops and commercialises pharmaceuticals and other medicaltechnologies. With a substantial and growing revenue stream of royalties andmilestone payments from out-licensed products, BTG continues to strengthen itspipeline of preclinical and clinical development programmes. Active in thefields of oncology, diseases of ageing, neuroscience, drug repositioning andmedical devices, BTG works from offices in London, Philadelphia and Osakathrough a global partner network of healthcare companies and researchorganisations. For further information, visit: www.btgplc.com. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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