Is the MS drug the primary value driver here or are there others?
August 1, 2017 TG Therapeutics Announces Special Protocol Assessment (SPA) Agreement with the FDA for a Phase 3 Program of TG-1101 (ublituximab) for Patients with Multiple Sclerosis (MS) Global Phase 3 Program Expected to Commence Before End of Q3 2017
International Phase 3 Trials Entitled "ULTIMATE I" and "ULTIMATE II" to be Led by Lawrence Steinman, MD, of Stanford University
NEW YORK, Aug. 01, 2017 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (Nasdaq:TGTX) announced today that it has reached an agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of two Phase 3 clinical trials for TG-1101 (ublituximab), the Company's glycoengineered anti-CD20 monoclonal antibody, for the treatment of relapsing forms of Multiple Sclerosis (RMS). The SPA provides agreement that the two Phase 3 trial designs adequately address objectives that, if met, would support the regulatory submission for approval of TG-1101.
The RMS Phase 3 program consists of two trials, called the ULTIMATE I and ULTIMATE II trials. Each trial is a global, randomized, multi-center, double-blinded, double-dummy, active-controlled study comparing TG-1101 (ublituximab) to teriflunomide in subjects with RMS. The primary endpoint for each study is Annualized Relapse Rate (ARR) following 96 weeks of treatment. Each trial will enroll approximately 440 subjects, randomized in a 1:1 ratio, with approximately 880 patients to be enrolled across both trials.
Lawrence Steinman, MD, George A. Zimmermann Professor and Professor of Pediatrics, Neurology and Neurological Sciences at Stanford University, and global study chair for both ULTIMATE I and ULTIMATE II trials commented, "B-cell targeted therapy with anti-CD20 monoclonal antibodies has been shown to be very active in the treatment of multiple sclerosis, and with the recent approval of ocrelizumab, we have entered a new era of B-cell targeted therapy for MS. The Phase 2 data recently presented for ublituximab demonstrates an encouraging safety and efficacy profile in the treatment of MS with this novel glycoengineered anti-CD20 monoclonal antibody. We are excited to lead this global Phase 3 program, and believe the unique attributes of ublituximab, in particular the rapid infusion times and potential pricing advantages, may provide added convenience and enhance patient care and access over currently available therapies."
Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics, stated "Reaching agreement with the FDA on the design of our Phase 3 program for TG-1101 in RMS has been a priority for us and we would like to thank the FDA for its invaluable guidance throughout this process. We have long believed the potential of TG-1101 is beyond oncology and believe this significant Phase 3 program will establish TG-1101 as an important new drug in the treatment of MS. The early data from our Phase 2 clinical trial, the highly successful pivotal results for the anti-CD20 monoclonal antibody ocrelizumab in MS, and the substantial safety data generated in our oncology program, gives us a high level of confidence in the potential for a successful outcome." Mr. Weiss continued, "Our team in concert with our CRO has been hard at work on the logistics and the launch of these Phase 3 trials on a global basis, and we look forward to enrolling our first patient before the end of the summer."
AI
