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     345  0 Kommentare TG Therapeutics Announces Presentation of Data from the ULTIMATE I & II Phase 3 Trials of BRIUMVI (ublituximab-xiiy) in Multiple Sclerosis at the 2023 Consortium of Multiple Sclerosis Centers Annual Meeting

    NEW YORK, June 02, 2023 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the presentation of data from the ULTIMATE I & II Phase 3 trials evaluating BRIUMVI (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the Consortium of Multiple Sclerosis Centers (CMSC) annual meeting. A link to the oral presentation is included below.

    Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics stated, “We were excited to present additional analyses from the ULTIMATE I & II Phase 3 trails last night at the CMSC annual meeting. We believe the data continue to support the unique attributes of BRIUMVI and we look forward to continuing to present additional data at medical meetings throughout the year.”

    Oral Presentation: Ublituximab Is Associated with Significant Improvement in Fatigue: Results from Ultimate I and II

    • Lead Author: Enrique Alvarez, MD, University of Colorado, Aurora, CO

    The data presentation is 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 TRIALS
    ULTIMATE I & II are two randomized, double-blind, double-dummy, parallel group, active comparator-controlled clinical trials of identical design, in patients with RMS treated for 96 weeks. Patients were randomized to receive either BRIUMVI, given as an IV infusion of 150 mg administered in four hours, 450 mg two weeks after the first infusion administered in one hour, and 450 mg every 24 weeks administered in one hour, with oral placebo administered daily; or teriflunomide, the active comparator, given orally as a 14 mg daily dose with IV placebo administered on the same schedule as BRIUMVI. Both studies enrolled patients who had experienced at least one relapse in the previous year, two relapses in the previous two years, or had the presence of a T1 gadolinium (Gd)-enhancing lesion in the previous year. Patients were also required to have an Expanded Disability Status Scale (EDSS) score from 0 to 5.5 at baseline. 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 and Neurological Sciences, Pediatrics and Genetics, at Stanford University. Additional information on these clinical trials can be found at www.clinicaltrials.gov (NCT03277261; NCT03277248).

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    TG Therapeutics Announces Presentation of Data from the ULTIMATE I & II Phase 3 Trials of BRIUMVI (ublituximab-xiiy) in Multiple Sclerosis at the 2023 Consortium of Multiple Sclerosis Centers Annual Meeting NEW YORK, June 02, 2023 (GLOBE NEWSWIRE) - TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the presentation of data from the ULTIMATE I & II Phase 3 trials evaluating BRIUMVI (ublituximab-xiiy) in patients with relapsing forms of multiple …

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