logo
Share SHARE
FONT-SIZE Plus   Neg

BTG Reports Positive Data From First US Phase III Trial Of Varisolve

Healthcare company BTG Plc (BGC.L) announced 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, or 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.

BTG noted that the study met all primary, secondary and tertiary efficacy endpoints. Patients treated with PEM showed a statistically significant improvement in symptoms, the study primary endpoint as measured by the VVSymQ score, compared with patients who received placebo.

The study's co-secondary endpoint, improvement of appearance as measured by both a patient-reported outcome, or PA-V3, and by a blinded independent panel review of photographs, or IPR-V3, was also met. Patients treated with PEM reported a statistically significant improvement in appearance in both the PA-V3 and IPR-V3 scores versus patients who received placebo.

Moreover, 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 compared to patients who received placebo.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
KMG Chemicals Inc. (KMG) is likely to beat earnings per share or EPS estimates, when it reports first quarter results on December 11, after the bell. First quarter results of KMG are expected to benefit from the impact of Irma and Harvey, and early October fires in the West. Sysco Corp. is looking ahead to own 50 fully electric semi tracks to be launched by Tesla. The new electric tractors could run 500 miles on a single charging. The order from the food service distribution giant that owns more than 7000 trucks is worth up to $10 million. Patreon, the crowdfunding platform for artists, announced Wednesday a change in its payment structure that it says will help creators keep more money. Meanwhile, many are concerned that the change may discourage their patrons from pledging.
comments powered by Disqus
Follow RTT