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TG Therapeutics Presents Data for Ublituximab at the 35th Annual Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)
NEW YORK, Sept. 12, 2019 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today presented the first look at the ULTIMATE I & II Phase 3 trial design
About this update from Tg Therapeutics, Inc.
[{"type":"text","content":"NEW YORK, Sept. 12, 2019 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today presented the first look at the ULTIMATE I & II Phase 3 trial design and demographic data and updated Phase 2 extension trial data for ublituximab, the Company’s novel, glycoengineered anti-CD20 monoclonal antibody, in relapsing forms of multiple sclerosis (RMS) at the 35th Annual Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), being held in Stockholm, Sweden.\n Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer stated, “We are pleased to present the first look at the study design and patient demographics data from our Phase 3 ULTIMATE program. Importantly, the population enrolled appears consistent with a typical RMS population and similar to the patient populations enrolled in other CD20 Phase 3 trials.” Mr. Weiss continued, “We are also highly encouraged by the Phase 2 long-term safety data demonstrating ublituximab continues to be very well tolerated with a median duration of follow-up of 124.7 weeks and no discontinuations due to AEs reported. We look forward to continuing to follow our Phase 2 patients and to topline results from our Phase 3 trial in the middle to second half of 2020. If successful, we believe ublituximab will represent an important anti-CD20 treatment option for patients with RMS that can be delivered in a convenient one-hour infusion every six months.” The following summarizes the highlights from each presentation during the 35th ECTRIMS meeting: Title: Study Design and Patient Demographics of the ULTIMATE Phase III Trials Evaluating Ublituximab (UTX), a Novel Glycoengineered Anti-CD20 Monoclonal Antibody (mAb), in Patients with Relapsing Multiple Sclerosis (RMS) This presentation includes the study design and demographic data from ULTIMATE I & II, two identical, randomized, international, multi-center, double-blinded, double dummy, active controlled Phase 3 trials, evaluating a twice per year one-hour 450mg infusion of ublituximab in RMS. These trials are being conducted under Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) and are being led by Lawrence Steinman, MD, of Stanford University. Presentation Highlights: Patient recruitment for ULTIMATE I & II was successfully completed in the second hal...