BTG Reports Successful Completion of Treatments in Varisolve® US Phase II Safety Study
No Subclinical Effects Found in MRI Scans to Date
London, UK, 6 June 2008: BTG plc (LSE: BGC), the life sciences company, announces the completion of enrolment and treatment of patients in the US Phase II safety study of Varisolve® polidocanol endovenous microfoam, which is under development as a treatment for varicose veins.
A total of 82 patients with saphenous vein incompetence were treated with Varisolve®, of whom 57 patients met the study requirement of having bubbles detected in the cerebral circulation during treatment. In line with the trial protocol, all 57 of these patients have had MRI brain scans 24 hours after treatment; 40 of these patients have also completed the required 28-day MRI scans with the remainder expected to complete their 28 day MRI scans by the end of June. To date, no MRI lesions, neurological abnormalities or elevated cardiac markers have been found as a result of the treatment in any of the patients.
Louise Makin, BTG’s chief executive officer, said: “We are delighted that we have found no evidence of subclinical effects in any patients following treatment with Varisolve® in this study. This supports our objective of developing Varisolve® for the widest possible patient base by enabling recruitment to the planned Phase III trials without having to screen future patients for cardiac shunts. It also allows us to embark on commercialisation discussions with potential partners with a valuable product that has now been significantly de-risked.”
Right-to-left cardiac shunts, which are estimated to be present in at least 25% of the population, can allow particles present in the venous system to cross into the arterial system and then into the brain, where they have the potential to block small vessels and cause injury. Following treatment with Varisolve®, transient residual microbubbles are present in the venous system. The study was conducted to investigate whether there was any evidence of subclinical effects in 50 patients with such shunts (more were treated to allow for possible late patient withdrawals from the study) following treatment with Varisolve®.
The full study results will be submitted for presentation at the November 2008 meeting of the American College of Phlebology.
In parallel with commercialisation discussions, BTG will conduct pilot studies to validate the photographic scales and questionnaires to be used in the Phase III pivotal trials.
For further information contact:
Andy Burrows, Director of Investor Relations
+44 (0)20 7575 1741
+44 (0)7990 530605 (mobile)
Christine Soden, Chief Financial Officer
+44 (0) 20 7575 1591
+44 (0)20 7831 3113
BTG in-licenses, develops and commercialises pharmaceuticals and has a broad pipeline of development programmes targeting neurological and other disorders including varicose veins. The company also has a substantial and growing revenue stream of milestone payments and royalties from out-licensed products. BTG operates from offices in London, Philadelphia and Osaka.