BTG Announces Positive Data from First US Phase III Trial of Varisolve®
Study meets all primary, secondary and tertiary endpoints
London, UK, 30 January 2012: BTG plc (LSE: BGC), the specialist healthcare company, today announces the successful outcome of VANISH-2, the first of two US pivotal Phase III studies comparing the safety and efficacy of Varisolve® (polidocanol endovenous microfoam (PEM)) with placebo in patients with symptomatic and visible varicose veins and saphenofemoral junction incompetence. Both pivotal Phase III studies are fully recruited, and all patients have been treated, reached the primary endpoint and are in long-term follow-up.
The study met all primary, secondary and tertiary efficacy endpoints. Patients treated with PEM (0.5% or 1.0% dose concentrations) demonstrated a statistically significant improvement in symptoms, the study primary endpoint as measured by the VVSymQ™ score, compared with patients who received placebo (p < 0.0001). The VVSymQ™ score is a patient-reported outcome measure of varicose vein symptoms developed and validated by BTG in accordance with FDA guidelines. The study's co-secondary endpoint, improvement of appearance as measured by both a patient-reported outcome (PA-V3™) and by a blinded independent panel review of photographs (IPR-V3™), was also met. Patients treated with PEM (0.5 or 1.0% dose concentrations) reported a statistically significant improvement in appearance in both the PA-V3 and IPR-V3 scores compared with patients who received placebo (p < 0.0001 and p < 0.0001, respectively).
The three tertiary endpoints, response to treatment as determined by duplex ultrasound, change in the Venous Clinical Severity Score and Quality of Life as measured by the modified VEINES-Sym/QOL questionnaire, were all statistically significantly better for patients treated with PEM (0.5% or 1.0% dose concentrations) compared to patients who received placebo (all at p < 0.0001).
In this study and across the whole Phase III programme, in which 590 patients received PEM and there were 984 PEM treatments in total, there were no serious or unexpected adverse events associated with the use of PEM. There were no cerebrovascular events or pulmonary emboli reported in any study. Chemically induced thrombosis occurred in 5.8% of PEM treatments, of which 0.5% were symptomatic deep vein thrombosis of the upper leg and 0.7% of the lower leg, respectively. The safety profile of PEM was consistent with previous clinical studies.
VANISH-2 investigator Dr Kenneth Todd, MD, South East Vein and Laser Centre, and American College of Phlebology Committee Member, said: "VANISH-2 is an important study because it is the first time patient benefit has been shown using a patient-reported outcome measure in a randomised controlled clinical trial in patients with varicose veins. If Varisolve® demonstrates the same sort of significant improvement in symptoms and acceptable safety profile in the additional Phase III trials, it should provide an important new treatment option for varicose veins. It has been a great trial to be part of as my patients have been so happy with their results."
Louise Makin, BTG's CEO, commented: "We are delighted with the successful outcome of VANISH-2. We look forward to the results of the second pivotal Phase III trial, VANISH-1, and to the results of study VV017 in which Varisolve® is used following heat ablation. These are both due in the first half of 2012, and we are on track to submit our US regulatory application by the end of 2012."
VANISH-2 included 235 patients who were randomised to receive treatment with one of three dose concentrations (0.125%, 0.5% or 1.0%) of PEM (n = 176) or "vehicle", effectively a placebo comparator (n = 59). The primary endpoint of the study was an improvement in symptoms recorded by patients using a novel patient-reported outcomes instrument, VVSymQ™. Patients scored a variety of symptoms such as swelling and aching using a daily electronic diary for 10 days prior to treatment (baseline) and for an additional 10 days prior to the primary endpoint at eight weeks following treatment. The secondary endpoint was the improvement in appearance and was measured both by patients, who used another novel, validated patient-reported outcome instrument, PA-V3™ and by an independent panel review of before and after photographs in a blinded setting using a validated clinician-reported instrument, IPR-V3™.
PEM is a unique patent-protected drug/device combination. It produces highly uniform CO2/O2 polidocanol endovenous microfoam engineered to improve safety and efficacy in the treatment of varicose veins. It is injected directly into the incompetent vein under ultrasound guidance, where it first displaces blood and then the polidocanol chemically ablates the inner lining of the vein wall, causing the vein to close. A compression bandage is applied to the leg for a period of approximately two weeks. If approved, this would be the first non-surgical, comprehensive treatment for varicose veins above and below the knee.
Forward Looking Statements
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