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Rapid and robust B-cell depletion reported in preliminary phase II study of ublituximab (29/06/17)

Relapsing remitting multiple sclerosis (RRMS) patients treated with ublituximab (TG-1101) have exhibited a median B-cell depletion of 99% at week four of an ongoing five month study, conducted by TG Therapeutics, Inc.

A total of 24 patients with RRMS have been treated with ublituximab. Three dosing cohorts of up to eight patients each were evaluated to assess the safety and tolerability of the drug at accelerated infusion times.

The drug was well tolerated, with no grade three to four adverse events reported. The most commonly reported adverse event was an infusion related reaction, with median time on study of five months.

All patients met the primary end-point of > 95% B-cell depletion by four weeks and the median B-cell depletion at week four was 99% after two infusions (day 1 and 15) with a cumulative dose of 600mg, which compares favourably with other anti-CD20 monoclonal antibodies. 

This data was presented at the 3rd Congress of the European Academy of Neurology (EAN), taking place in Amsterdam, by Dr. Edward Fox, MD, PhD, Director of the Multiple Sclerosis Clinic of Central Texas, Clinical Assistant Professor at the University of Texas Medical.

Source: MS-UK (29/06/17)