Business
TG Therapeutics Announces Publication of Ublituximab Phase 2 Clinical Trial Results in Multiple Sclerosis Journal
Ublituximab was generally well tolerated across all cohorts including those patients receiving one-hour infusions for the 450mg dose currently being studied
About this update from Tg Therapeutics, Inc.
[{"type":"text","content":"Ublituximab was generally well tolerated across all cohorts including those patients receiving one-hour infusions for the 450mg dose currently being studied in the Phase 3 ULTIMATE MS program\n Annualized Relapse Rate of 0.07 observed at week 48 NEW YORK, May 01, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced the publication of results from the multicenter Phase 2 trial evaluating ublituximab, the Company’s investigational, glycoengineered, anti-CD20 monoclonal antibody, in patients with relapsing forms of multiple sclerosis (RMS), in the Multiple Sclerosis Journal. Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer stated, “We are extremely pleased to see the ublituximab Phase 2 results published in Multiple Sclerosis Journal. Anti-CD20 therapy has quickly become a very important treatment option for patients with MS, and we believe our Phase 2 data highlight the potential therapeutic benefits for ublituximab delivered in a convenient one-hour infusion following day 1. Further, these Phase 2 data strengthen our confidence in the design of our fully enrolled Phase 3 ULTIMATE program for ublituximab in RMS, for which we are targeting topline data in the second half of this year.” Mr. Weiss continued, “We want to thank Dr. Edward Fox as well as the investigators and staff at each of the participating trials sites, and most importantly the patients who participated in this study.” Edward Fox, MD, PhD, Director of the Multiple Sclerosis Clinic of Central Texas at Central Texas Neurology Consultants, Clinical Associate Professor at the University of Texas Dell Medical School in Austin, TX and the Principal Investigator for this Phase 2 study stated, “The encouraging clinical data we have published illustrate the potential for ublituximab in the treatment of patients with relapsing forms of multiple sclerosis. The compelling efficacy findings and favorable tolerability profile reported in this Phase 2 study along with the one-hour infusion time are promising and support a differentiated profile for ublituximab.” Dr. Fox continued, “I am encouraged that all patients who completed the 48-week Phase 2 trial entered the extension phase of the study and look forward to updates from the Phase 2 extension, as well as to topline data from the Phase 3 trials evaluating ublituximab late...