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
KFC has brought its "Finger Lickin' Good" tag line to life by creating KFC-flavored nail polishes. KFC Hong Kong has partnered with advertising agency Ogilvy & Mather to make "Original" and "Hot & Spicy" edible nail polishes. The flavors contain natural ingredients and are based on KFC's two popular... Telecom giant AT&T Inc. has awarded a contract to host its web and mobile portals to Synacor Inc., ending a major portion of its 15-year old deal with Yahoo! Inc. The move by AT&T deals a blow to Yahoo!'s already shrinking search and display ad business and comes at a time when the struggling Internet giant is weighing offers from potential bidders. Chinese e-commerce giant Alibaba Group Holding Limited on Thursday reported an 85 percent surge in profit for the fourth quarter from last year on strong revenue growth, mainly driven by the continued rapid growth of the company's China commerce retail business. Shares of the company are gaining almost 3 percent in pre-market activity.
comments powered by Disqus
Follow RTT