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NEW YORK, June 03, 2022 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced data presentations, including one oral and two poster presentations, highlighting data from exploratory and pooled analyses from the ULTIMATE I & II Phase 3 trials evaluating ublituximab in patients with relapsing forms of multiple sclerosis (RMS), presented at the Consortium of Multiple Sclerosis Centers (CMSC) annual meeting. Links to the presentations are included below.
Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics stated, “We are pleased to have presented three data sets at the CMSC conference yesterday. We believe these data further support the previously reported positive Phase 3 results from the ULTIMATE I and II studies.” Mr. Weiss continued, “We continue to be encouraged by the feedback received at this week’s conference, which reinforces our confidence in the commercial potential of ublituximab, if approved.”
CMSC 2022 Presentations
Oral Presentation:Reduced Disease Progression with Ublituximab Vs Teriflunomide in the Phase 3 Ultimate I and II Studies in Relapsing Multiple Sclerosis
Poster Presentation:Improved Cognitive Processing Speed with Ublituximab in Patients with Highly Active Relapsing Multiple Sclerosis
Poster Presentation:Infusion-Related Reactions with Ublituximab in the Phase 3 Ultimate I and II Studies in Relapsing Multiple SclerosisThe above data presentations are also available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.cfm.
ABOUT THE ULTIMATE I & II PHASE 3 TRIALSULTIMATE I and ULTIMATE II are two independent Phase 3, randomized, double-blinded, active-controlled, global, multi-center studies evaluating the efficacy and safety/tolerability of ublituximab (450mg dose administered by one-hour intravenous infusion every 6 months, following a Day 1 infusion of 150mg over four hours and a Day 15 infusion of 450mg over one hour) versus teriflunomide (14mg oral tablets taken once daily) in subjects with relapsing forms of Multiple Sclerosis (RMS). The ULTIMATE I & II trials enrolled a total of 1,094 patients with RMS across 10 countries. These trials were led by Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University and were conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). As previously announced, both studies met their primary endpoint with ublituximab treatment demonstrating a statistically significant reduction in annualized relapse rate (ARR) compared to terifunomide over a 96-week period (p
