TG Therapeutics, Inc. Announces Completion of Enrollment and B-Cell Depletion Data from Part 1 of Ongoing Phase 2 Multiple Sclerosis Study
January 11, 2017 at 06:00 pm IST
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TG Therapeutics, Inc. announced that the completion of enrollment into Part 1 of its ongoing Phase 2 study of TG-1101 (ublituximab), the company's novel glycoengineered anti-CD20 monoclonal antibody, in patients with relapsing forms of multiple sclerosis. The study, led by Edward Fox, MD, PhD, Director of the Multiple Sclerosis Clinic of Central Texas and Clinical Assistant Professor at the University of Texas Medical Branch in Round Rock, TX, evaluated three dosing cohorts, each with 8 patients. The primary objective of the study was to assess the safety and tolerability of TG-1101 in patients with RMS as well as to determine the optimal dosing regimen for TG-1101 by examining the level of B-cell depletion and the tolerability of accelerated infusion times. Established MS clinical efficacy endpoints are also being evaluated, which require longer-term follow-up and are anticipated to be reported on later this year or next year at a medical conference. Part 1 of the study is exploring TG-1101 at an initial dose of 600 mg administered as a 150 mg infusion on day 1 and 450 mg infusion on day 15, followed by either 450 mg or 600 mg at week 24. The day 15 and week 24 doses were subject to accelerated infusion times by cohort, down to a 1-hour infusion by cohort 3. The median B-cell depletion for all patients in Part 1 was 99% and TG-1101 was well-tolerated with no grade 3/4 adverse events reported, including in patients receiving the one-hour infusion at the target Phase 3 dose and infusion rate. As Part 2 of the trial, the company has added expansion cohorts and will explore accelerated dosing of the initial 150mg dose.
TG Therapeutics, Inc. is a fully integrated, commercial stage, biopharmaceutical company. The Company is focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. Its clinical drug candidates include Ublituximab (anti-CD20 mAb), TG-1701 (BTK inhibitor) and TG-1801 (anti-CD47/CD19 bispecific mAb). BRIUMVI is an anti-CD20 monoclonal antibody for the treatment of RMS, which include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. TG-1701 is a novel, orally available and covalently bound Brutonâs tyrosine kinase (BTK) inhibitor that exhibits selectivity to BTK in in vitro kinase screening. TG-1801 is a bispecific CD47 and CD19 antibody. It is the therapy to target both CD19, a B-cell specific market expressed across B-cell malignancies, and CD47. It also evaluates complementary products, technologies and companies for in-licensing, partnership, acquisition and/or investment opportunities.