TG Therapeutics Announces Completion of Target Enrollment in the ULTIMATE Phase 3 Trials in Multiple Sclerosis
Aug 07, 2018
ABOUT THE ULTIMATE TRIALS
ULTIMATE I and ULTIMATE II are two independent Phase 3 trials. Each trial is a global, randomized, multi-center, double-blinded, double-dummy, active-controlled study comparing ublituximab (TG-1101) to teriflunomide in subjects with relapsing forms of Multiple Sclerosis (RMS). The primary endpoint for each study is Annualized Relapse Rate (ARR) following 96 weeks of treatment. Additional information on these clinical trials can be found at www.clinicaltrials.gov.
TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is developing two therapies targeting hematological malignancies and autoimmune diseases. Ublituximab (TG-1101) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing umbralisib (TGR-1202), an orally available PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B‐lymphocytes. Both ublituximab and umbralisib, or the combination of which is referred to as "U2", are in Phase 3 clinical development for patients with hematologic malignancies, with ublituximab also in Phase 3 clinical development for Multiple Sclerosis. Additionally, the Company has recently brought its anti-PD-L1 monoclonal antibody into Phase 1 development and aims to bring additional pipeline assets into the clinic in the future. TG Therapeutics is headquartered in New York City.
Statements included in this press release, particularly those with respect to anticipating the benefit of the early data seen in the Phase 2 MS trial, as well as anticipating the timing of the release of additional data from our Phase 2 MS trial and the timing of complete enrollment or anticipation of positive data from our Phase 3 ULTIMATE program in MS may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete the MS Phase 2 trial; the risk that early clinical results from the MS Phase 2 trial will not be reproduced in the final MS Phase 2 data or in the MS Phase 3 ULTIMATE trials; the risk that the clinical results from the MS Phase 3 program, will be not positive and/or will not support regulatory approval of ublituximab for MS; the risk that ublituximab will not have a differentiated profile from the other drugs in the class; the risk that some of the perceived attributes of ublituximxab in MS, in particular the infusion times and potential pricing advantages may not be incorporated into future plans; the risk that some or all of the pivotal trials expected by mid-2020 will be delayed, will be not be considered pivotal and/or will not be positive or otherwise not support regulatory approval; and other risk factors identified from time to time in our reports filed with the
Senior VP, Corporate Communications
Source: TG Therapeutics, Inc.