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TG Therapeutics Announces Data Presentations from the ULTIMATE I & II Phase 3 Trials of Ublituximab in Multiple Sclerosis to be Presented at the 2022 Consortium of Multiple Sclerosis Centers Annual Meeting

Published: 2022-05-26 11:30:00 ET
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NEW YORK, May 26, 2022 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the schedule of data presentations, including one oral and two poster presentations, highlighting data from the ULTIMATE I & II Phase 3 trials evaluating ublituximab in patients with relapsing forms of multiple sclerosis (RMS), at the upcoming Consortium of Multiple Sclerosis Centers (CMSC) annual meeting, being held June 1-4, 2022, in National Harbor, Maryland. Abstracts are now available online and can be accessed on the International Journal of MS Care (IJMSC) website at www.ijmsc.org, or by following this direct link https://doi.org/10.7224/1537-2073-24.s1.1. Details of the presentations are outlined below. Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics stated, “We are excited to be presenting three data sets from the ULTIMATE I & II Phase 3 trials at the 2022 CMSC annual meeting next week, including an oral presentation highlighting reduced disease progression with ublituximab compared to teriflunomide in patients with RMS.” Mr. Weiss continued, “We look forward to next week’s meeting and to sharing these additional data.”

Oral Presentation Title: Reduced Disease Progression with Ublituximab Vs Teriflunomide in the Phase 3 Ultimate I and II Studies in Relapsing Multiple Sclerosis

  • Presentation Date/Time: Thursday, June 2, 2022/ 3:10 – 3:30 PM ET
  • Session: Disease Modifying Therapies Platform Session
  • Presentation ID: DMT03
  • Lead Author: Enrique Alvarez, MD, University of Colorado, Aurora, CO

Poster Presentation Title: Improved Cognitive Processing Speed with Ublituximab in Patients with Highly Active Relapsing Multiple Sclerosis

  • Presentation Date/Time: Thursday, June 2, 2022 / 5:00 – 7:00 PM ET
  • Session: Poster Session in Prince George’s Exhibit Hall
  • Poster Board Label: DMT19
  • Lead Author: Derrick Robertson, MD, University of South Florida, Tampa, FL

Poster Presentation Title: Infusion-Related Reactions with Ublituximab in the Phase 3 Ultimate I and II Studies in Relapsing Multiple Sclerosis

  • Presentation Date/Time: Thursday, June 2, 2022 / 5:00 – 7:00 PM ET
  • Session: Poster Session in Prince George’s Exhibit Hall
  • Abstract Number/Poster Number: DMT23
  • Lead Author: Edward J. Fox, MD, PhD, Central Texas Neurology Consultants, Round Rock, TX

Following the presentations, the data presented will be 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