BTG's varicose vein treatment given green light for US trials

Stephen Foley
Monday 13 January 2014 05:01
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BTG, the intellectual property group, has finally gained approval to start US trials of its most exciting new drug product after protracted wrangling with regulators.

Varisolve, a revolutionary foam injected into varicose veins to treat the condition without the need for surgery, had been expected to start large-scale clinical trials in the US in the first three months of the year.

But the Food & Drug Administration has been concerned over the safety of the procedure and has only given a green light to a small pilot study involving 20 patients, which will start in September.

The company hailed this as a breakthrough and expressed confidence that a full-scale trial, involving up to 750 patients, will be launched soon after.

The shares, which have fallen by more than a half since BTG missed its March target date for the start of trials, rebounded 12.75p to 263.25p.

The company admitted that Varisolve will not now be on the market in the US in 2005, as promised, but rather in 2006. The product is still on course for a 2005 launch in Europe, where 350 patients have already been treated in trials and where, according to the company, the results have been encouraging.

An estimated 150 million people in the West suffer from varicose veins, with 4 million new cases a year.

Ian Harvey, BTG's chief executive, said the company was close to signing a manufacturing deal for Varisolve, and would also be able to start the search for a marketing partner by the end of the year.

BTG was formed out of the National Research Development Corporation and sold off by the British Government in 1992. It finds, develops and commercialises new technologies in medicine and electronics and has a portfolio of more than 300 new technologies at varying stages of development.

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