TG Therapeutics (TGTX) Presents Encouraging Data from TG-1101 Phase 1b in NMO, NMOSD

September 16, 2016 10:36 AM EDT

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TG Therapeutics, Inc. (Nasdaq: TGTX) announced the presentation of data from a Phase Ib open label study of TG-1101 (ublituximab), the Company’s novel, glycoengineered anti-CD20 monoclonal antibody, for the treatment of patients with acute optic neuritis and/or transverse myelitis in neuromyelitis optica (NMO) and neuromyelitis optica spectrum disorder (NMOSD). The data is being presented today, Friday, September 16, 2016, from 15:30 – 17:00 BST, at the 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), being held at the ExCel, in London, UK.

The poster, entitled “Phase Ib, open label study of ublituximab in acute relapses of neuromyelitis optica spectrum disorder,” (Abstract Number: P1195), is being presented by Michael Levy, MD, PhD, an Associate Professor of Neurology & Director of the Neuromyelitis Optica Clinic at the Johns Hopkins University, and principle investigator of the study, and includes data from patients with acute NMO relapses treated with a combination of ublituximab and corticosteroids. Highlights from the poster include:

  • A single 450 mg infusion of TG-1101 (ublituximab) rapidly and effectively depleted B-cells during acute NMO relapses without significant risks in this patient population
  • TG-1101 was well tolerated, with minimal adverse events and no SAEs or infections observed
  • Timed 25-foot walk and visual acuity, NMO-specific functional measures of recovery, improved along with EDSS scores in patients treated with TG-1101 in combination with corticosteroids

“We are encouraged by the ability of TG-1101 to safely and rapidly deplete B-cells, even with a single low dose, which we believe will be key to the success of TG-1101 in treating patients with autoimmune disorders such as NMO/NMOSD and multiple sclerosis,” stated Michael S. Weiss, Executive Chairman and Interim CEO of TG Therapeutics. Mr. Weiss continued, “NMO and NMOSD, disorders which are closely related to multiple sclerosis, represent areas of significant unmet medical need, with no currently approved treatments. We are pleased by the data presented today as well as the orphan drug status that was granted to TG-1101 in NMO and NMOSD just a few weeks ago. We look forward to reviewing additional information from this trial as well as exploring future clinical trial opportunities in NMO and multiple sclerosis.” A copy of the poster presentation is available on the Company’s website at, located on the Publications Page, within the Pipeline section.

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