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 of Varisolve®, which is being developed to treat varicose veins and venous stasis ulcers, is being presented today at the Annual Scientific Meeting of the Society of Interventional Radiologists in Washington, DC.
The study is investigating whether treatment with Varisolve® polidocanol microfoam can cause subclinical events such as microinfarctions in the brains of varicose 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 the venous into the arterial circulation. The study finishes when 50 patients with bubbles detected in the middle cerebral artery (MCA) have been treated and followed 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 with great saphenous vein incompetence who were screened for enrolment into the study were diagnosed with R-L shunts. In shunt-positive patients, 83% had detectable MCA bubbles during the Varisolve® procedure, though the number of bubbles was generally very low (median of 5 detectable bubbles). After evaluation of 28 eligible 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 endovenous occlusion are commonly exposed to gas bubbles in the cerebral arterial circulation. Exposure to this proprietary microfoam, which has a controlled density, bubble size and gas mix, has not been associated with evidence of microinfarction.”
Louise Makin, BTG’s chief executive officer, said: “With over half the required patients now treated, the study is progressing as planned and continues to validate our belief in the unique attributes of Varisolve®.”
In parallel with the Phase II study, BTG is advancing other aspects of the product’s development. Supply chain arrangements have been simplified and a user-friendly single-can product presentation will be ready for use in the Phase III studies. Having agreed with the FDA the Phase III plans in outline, BTG is initiating a pilot Phase III study to test and finalise the procedures to be incorporated into the pivotal Phase III trial protocols. Market research studies underway confirm our belief that Varisolve® has the potential to be competitive in an underserved market, with significant patient and physician benefits over existing varicose vein treatments.
For further information contact: BTG Financial Dynamics Andy Burrows, Director of Investor Relations +44 (0)20 7575 1741; mobile: +44 (0)7990 530605 Christine Soden, Chief Financial Officer +44 (0)20 7575 1591 Ben Atwell +44 (0)20 7831 3113
