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BTG PLC: PROVENSIS RECEIVES FDA APPROVAL TO COMMENCE PILOT STUDY WITH VARISOLVE
BTG plc, the global technology commercialisation company, today announced that its subsidiary Provensis Ltd has gained approval from the Food & Drug Administration to commence the first stage of a pilot study in patients in the US with Varisolve, the non-invasive procedure being developed to treat varicose veins. Successful conclusion of the pilot study, which is expected to begin in September 2002, should, subject to FDA approval, lead to a large scale Phase III pivotal trial. In the ongoing European Phase III trial, 350 patients have already been treated with Varisolve, and the observed clinical response has been encouraging. 182 patients have received comparative treatments. Ian Harvey, BTG’s chief executive officer, commented: “We are very pleased that Provensis has gained approval to begin clinical studies with Varisolve in the US. In Europe, efficacy data from the ongoing trial will be available by the end of the year, at which time we plan to commence discussions with potential sales and marketing partners. We also expect in the coming months to complete manufacturing arrangements for the Varisolve product.” Varisolve is a virtually painless out-patient treatment for varicose veins being developed to provide an alternative to surgery. Over 150 million people in the US and Europe suffer from varicose veins and could benefit from surgery. Approximately 4 million new cases arise each year.
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