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Data from a Phase Ib Clinical Trial of TG-1101 in Patients with Neuromyelitis Optica (NMO) presented at the 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis

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Additional Information

Clinical Data
  • 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."
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Catalyst Date
Occurred on:
Sep 16, 2016
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Related Keywords Phase Ib, Tg-1101, Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder, Multiple Sclerosis