NEW YORK, June 18, 2018 (GLOBE NEWSWIRE) — TG Therapeutics, Inc. (NASDAQ:TGTX), today announced updated results from the Phase 2 multicenter trial of ublituximab (TG-1101), the Company’s novel glycoengineered anti-CD20 monoclonal antibody, in relapsing forms of Multiple Sclerosis (RMS). The data is being presented today at the 4thCongress of the European Academy of Neurology in Lisbon, Portugal, via an oral session titled “MS and related Disorders 2”, at 17:00 CET.
Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated, “We are extremely pleased to see that the preliminary Week 48 data presented today from this Phase 2 trial supports the Week 24 data presented earlier this year at the AAN meeting. While only an early look at the Week 48 timepoint, the data continue to be impressive and suggestive of a highly efficacious anti-CD20 monoclonal antibody with a manageable safety profile that can be administered in a convenient one-hour infusion. Mr. Weiss continued, “We look forward to presenting the final results from this Phase 2 trial including Week 48 data on up to 48 patients at a major medical meeting later this year.”
This Phase 2 trial is a 48-week randomized, placebo controlled, multi-center study evaluating the safety and efficacy of ublituximab at accelerated infusion times as fast as one hour. Today’s oral presentation includes Week 24 data from 48 patients with relapsing forms of multiple sclerosis (RMS) that were treated with ublituximab across six dosing cohorts, as well as data from the first 14 patients through Week 48.
|•||An Annualized Relapse Rate (ARR) of 0.07, calculated cumulatively, based on 48 subjects with a mean follow-up of approximately 11 months|
|•||99% median B-cell depletion was observed at week 4 and maintained at Week 24 (n=44)|
|•||Ublituximab completely eliminated all (100%) of T1 Gd-enhancing lesions at Week 24 (n=44) (p=0.003) and at Week 48 (n=14)|
|•||7.67% Reduction in T2 lesion volume at Week 24 from baseline (n=44) and a 10.5% reduction in T2 lesion volume at Week 48 from baseline (n=14)|
|•||Ublituximab was well tolerated across all patients including those receiving rapid infusions, as low as a one hour for the 450mg Phase 3 dose|
These data presentations support the international Phase 3 ULTIMATE program evaluating ublituximab for the treatment of relapsing forms of Multiple Sclerosis (RMS). The Phase 3 trials, entitled ULTIMATE I and ULTIMATE II, 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. The ULTIMATE trials are currently enrolling and complete enrollment is expected by the end of 2018.
A copy of the above poster can be found on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtxinc.com/publications.cfm.
ABOUT TG THERAPEUTICS, INC.
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.
Jun 18, 2018