13th Dec 2006 11:10
BTG PLC13 December 2006 Results of European Phase III Randomised Controlled Trial Comparing Varisolve(R) with Surgery or Sclerotherapy Published in Phlebology London, UK, 13 December 2006: BTG plc (LSE: BGC), the medical innovationscompany, announces that the full results of the Phase III European trial ofVarisolve(R), the novel microfoam treatment for varicose veins, have beenpublished in the journal Phlebology 1, confirming the non-inferiority ofVarisolve(R) to the alternative treatments. The trial was an open-label, multi-centre, randomised, prospective studycomparing Varisolve(R) to surgery and sclerotherapy in the management ofpatients with moderate to severe varicose veins. The results of the trial showedthat Varisolve(R) met the study objective in that overall it was shown to benon-inferior to alternative treatments, with 83.4% efficacy for Varisolve(R) and88.1% efficacy for alternative treatments at three months, and 78.9% efficacyfor Varisolve(R) and 80.4% efficacy for alternatives at 12 months. "These full data from the one-year follow-up of the European Phase III trialconfirm that Varisolve(R) is an effective and well tolerated treatment forvaricose veins, with significant advantages for patients over alternativetreatments," commented Louise Makin, BTG's CEO. "We continue to believeVarisolve(R) has significant commercial potential, and are continuing its USdevelopment with the phase II safety study." In the trial, patients were treated in two randomised cohorts - Varisolve(R) vssurgery (178 Varisolve(R) patients) and Varisolve(R) vs sclerotherapy (259Varisolve(R) patients) - to receive either the Varisolve(R) procedure or thealternative treatment in a ratio of 2:1 in favour of the Varisolve(R) technique.Efficacy and safety were assessed by duplex scanning on days 7 and 28, and atmonths 3 and 12. The primary endpoint was the response to treatment at month 3, defined as theocclusion of incompetent trunk vein(s) and the elimination of reflux in thetreated vein(s). To be a responder, both occlusion (or for surgery the absence)of the treated vein and elimination of junctional reflux were required. Secondary endpoints included: severity of post-procedure pain, time taken toreturn to normal activities, number of treatment sessions required and month 12response rate. Analysing the cohorts separately at month 3, the response rates were 68.2% forVarisolve(R) and 87.2% for surgery in the Varisolve(R) vs surgery cohort, and93.8% for Varisolve(R) and 88.8% for sclerotherapy in the Varisolve(R) vssclerotherapy cohort. At month 12, the superiority of surgery over Varisolve(R)was maintained in the Varisolve(R) vs surgery cohort (86.2% versus 63.1%), whileVarisolve(R) was superior to sclerotherapy in the Varisolve(R) vs sclerotherapycohort (89.6% versus 76%). The authors of the paper conclude that the reducedefficacy of Varisolve(R) when delivered by vascular surgeons resulted in partfrom the lack of experience of this group in using sclerotherapy for largeveins. In terms of the secondary endpoints, surgery was associated with more pain thanVarisolve(R) (day 6: surgery median score 9, Varisolve(R) median score 2 on thevisual analogue scale). The median time to resume normal activities was 2 daysfollowing treatment with Varisolve(R) compared with 13 days following surgicaltreatment in the Varisolve(R) vs surgery cohort. No difference was observed inthe time to resume normal activities between the patients treated with Varisolve(R) or sclerotherapy in the Varisolve(R) vs sclerotherapy cohort. More patientscompleted treatment in a single session in the Varisolve(R) group than in thesclerotherapy group (92.2% versus 74.4%). The most common adverse events relating to Varisolve(R) use were mild contusion,skin discolouration and limb pain. There were six reports of neurologicalsymptoms occurring within 24 h of treatment, which were short-lived and resultedin no clinical findings during follow-up examinations. Deep vein thromboses(DVT) occurred in 11 patients treated with the Varisolve(R) procedure, promptingtechnique changes and following which no further DVTs have been found in 150patients treated subsequently in this and other studies. The authors conclude that Varisolve(R) is capable of sclerosing majorincompetent trunk veins and tributaries, usually in a single outpatient session.It is effective in over 80% of cases and is well tolerated, which support theVarisolve(R) technique as an appropriate future treatment for patients withvaricose veins and trunk vein incompetence. For further information: BTG Financial DynamicsAndy Burrows, Director of Investor Relations Ben Atwell / Anna Keeble+44 (0)20 7575 1741 +44 (0)20 7831 3113Christine Soden, Chief Financial Officer+44 (0)20 7575 1591 Notes 1 Wright D et al. Varisolve(R) polidocanol microfoam compared with surgery orsclerotherapy in the management of varicose veins in the presence of trunk veinincompetence: European randomized controlled trial. Phlebology 2006;21;4:180-90 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 its offices in London, Philadelphia and Osakawith 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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