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Sunday, September 22, 2019

#ECTRIMS2019 – Data Shows Ublituximab’s Long-term Safety in Relapsing MS, TG Therapeutics Announced

Ublituximab (TGTX-1101) is a glycoengineered anti-CD20 monoclonal antibody being developed by TG Therapeutics  as a potential treatment for relapsing (RMS). Evidence shows that B-cells are activated during a relapse, and these immune system cells are found within acute lesions of the spinal cord, which suggests a role in MS flares.
Ublituximab targets a specific receptor on the CD20 antigen found on mature B-cells, depleting their number in the blood and central nervous system.
Originally developed to treat B-cell proliferative disorders like non-Hodgkin’s lymphoma and chronic lymphocytic leukemia, ublituximab is now also being studied in autoimmune diseases like MS, lupus and rheumatoid arthritis.

Ublituximab (TGTX-1101) research in RMS

TG Therapeutics released early data from a Phase 2 study (NCT0273877) assessing ublitiximab’s safety and efficacy in RMS patients in January 2017. The first part of the study, being led by Edward Fox, director of the Multiple Sclerosis Clinic of Central Texas and a professor at the University of Texas Medical Branch in Round Rock, evaluated ublitiximab at three different doses in three groups of patients (eight per group; infusions given on days 1 and 15 and week 24, and accelerated in two cohorts). In addition to safety and accelerated infusion tolerability, this initial part was to determine an optimal dosage by examining B-cell depletion up to week 24. (Data on other MS efficacy measures is still being collected and evaluated.)
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