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VARISOLVE shown similar in efficacy to, and with significant potential advantages over, existing treatments

BTG : 05 October, 2006  (Company News)
BTG plc, the global technology commercialisation company, today announced the preliminary results of a pivotal European Phase III trial of the VARISOLVE endovenous microfoam procedure, being developed by its subsidiary Provensis Ltd as a new treatment for varicose veins.
The overall response rate in patients treated with VARISOLVE was 83.4%, in line with expectations. This response rate is based on a very stringent primary endpoint, being the achievement of both occlusion (closure) of the treated vein and elimination of significant reflux (flow of blood back into the vein) as measured three months after treatment. Using the more conventional success criterion of either occlusion or elimination of reflux, VARISOLVE achieved a response rate of 89.6%.

The trial was designed to establish whether VARISOLVE is similar in efficacy to conventional treatments (sclerotherapy or surgery) in the treatment of moderate to severe varicose veins, based on the primary endpoint. In total, 654 patients (68% female) were treated at 15 centres in the UK, France, The Netherlands, Belgium, Germany, Sweden and Italy. Patients were initially assigned by their physician for treatment with either sclerotherapy (liquid or foam) or surgery. Within each of these two cohorts they were then randomised in a 1:2 ratio to receive the assigned treatment or VARISOLVE. There was no significant difference between the overall response rate of patients treated with VARISOLVE (83.4%) and established alternative treatments (87.7%), hence the main goal of the trial was established. The trial also suggested significant potential benefits over existing treatments:

In the surgery cohort, VARISOLVE patients required on average only 2 days to return to normal activities following treatment compared with 13 days for patients treated surgically.
Patients treated with VARISOLVE experienced less pain than surgery-treated patients, measured using an established “visual analogue score” method after 1, 3 and 7 days.
Only 7.8% of legs required re-treatment with VARISOLVE, whereas 24.8% of conventional sclerotherapy injections had to be repeated.
Dr J-P Gobin, Independent Phlebologist in Lyon and lead investigator in France for the Phase III trial, commented: “This trial has shown that VARISOLVE microfoam has great potential for the treatment of varicose veins. The microfoam is sterile, uniform and stable, and induces rapid onset of venospasm. It is convenient to administer, for both patient and physician, and treatment can be completed in a single session.'

In total, 435 patients received VARISOLVE, 125 received conventional sclerotherapy and 94 were treated with surgery. For the primary endpoint (both elimination of significant reflux and occlusion of the treated vein), VARISOLVE was similar in efficacy to the alternative treatments overall: 363 of 435 (83.4%) VARISOLVE patients responded, while 192 of 219 (87.7%) patients receiving established treatments responded. Within the sclerotherapy cohort, 93.8% of VARISOLVE patients responded and 88.8% of sclerotherapy patients responded. In the surgery cohort, 68.2% of VARISOLVE patients responded compared with 86.2% of surgery patients.

Further analysis using either elimination of reflux or occlusion of the treated vein as the criterion for a positive response showed that VARISOLVE had an overall response rate of 89.6%. In the sclerotherapy cohort the response rates with VARISOLVE were 96.3% for treatment of the long saphenous vein 1 and 95.3% for treatment of the short saphenous vein, compared with 96.9% and 92.9% respectively with sclerotherapy. In the surgery cohort, the response rates with VARISOLVE were 84.6% for the LSV and 66.7% for the SSV, compared with 87.5% and 58.3% respectively with surgery.

Ian Harvey, Chief Executive Officer of BTG, commented: “We are very pleased with these results, which confirm our view that VARISOLVE represents a significant advance in the treatment of varicose veins with similar efficacy to, but major advantages over, existing treatments. We look forward to filing the first European marketing authorisation application, as planned.”

These preliminary results will be presented to an international audience of phlebologists at the UIP congress in San Diego, USA, on 30 August. The final study report is due later this year.
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