17th Mar 2008 09:33
BTG PLC17 March 2008 BTG plc: Positive Interim Report of Varisolve(R) Phase II Safety Study to be Presented at SIR 2008 Scientific Meeting London, UK, 17 March 2008: BTG plc (LSE: BGC), the life sciences company,announces that a positive interim report of the US Phase II safety study ofVarisolve(R), which is being developed to treat varicose veins and venous stasisulcers, is being presented today at the Annual Scientific Meeting of the Societyof Interventional Radiologists in Washington, DC. The study is investigating whether treatment with Varisolve(R) polidocanolmicrofoam can cause subclinical events such as microinfarctions in the brains ofvaricose vein patients with right-to-left (R-L) cardiac shunts. R-L shunts, e.g.patent foramen ovale, may allow bubbles to enter the brain by crossing from thevenous into the arterial circulation. The study finishes when 50 patients withbubbles detected in the middle cerebral artery (MCA) have been treated andfollowed up at 24 hours and 28 days using MRI scanning and other procedures. Study investigator John Regan, M.D. will report that 40% of the patients withgreat saphenous vein incompetence who were screened for enrolment into the studywere diagnosed with R-L shunts. In shunt-positive patients, 83% had detectableMCA bubbles during the Varisolve(R) procedure, though the number of bubbles wasgenerally very low (median of 5 detectable bubbles). After evaluation of 28eligible patients with MCA bubbles, none had developed new MRI lesions,neurological or other visual field abnormalities, or elevated cardiac markers. Dr Regan commented: "It is clear that patients undergoing microfoam endovenousocclusion are commonly exposed to gas bubbles in the cerebral arterialcirculation. Exposure to this proprietary microfoam, which has a controlleddensity, bubble size and gas mix, has not been associated with evidence ofmicroinfarction." Louise Makin, BTG's chief executive officer, said: "With over half the requiredpatients now treated, the study is progressing as planned and continues tovalidate our belief in the unique attributes of Varisolve(R)." In parallel with the Phase II study, BTG is advancing other aspects of theproduct's development. Supply chain arrangements have been simplified and auser-friendly single-can product presentation will be ready for use in the PhaseIII studies. Having agreed with the FDA the Phase III plans in outline, BTG isinitiating a pilot Phase III study to test and finalise the procedures to beincorporated into the pivotal Phase III trial protocols. Market research studiesunderway confirm our belief that Varisolve(R) has the potential to becompetitive in an underserved market, with significant patient and physicianbenefits over existing varicose vein treatments. For further information contact: BTG Financial DynamicsAndy Burrows, Director of Investor Relations Ben Atwell+44 (0)20 7575 1741; mobile: +44 (0)7990 530605 +44 (0)20 7831 3113 Christine Soden, Chief Financial Officer+44 (0)20 7575 1591 About BTG BTG in-licenses, develops and commercialises pharmaceuticals principally in theareas of neuroscience and oncology. The company has a substantial and growingrevenue stream of royalties from out-licensed products and a broad, expandinginternal pipeline of development programmes. BTG operates from offices inLondon, Philadelphia and Osaka. 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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