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Phase 2 Trial of TG-1101 is Underway

May 23, 2016

TG Therapeutics recently announced the opening of a new clinical trial evaluating TG-1101, its glycol-engineered anti-CD20 monoclonal antibody, in patients with relapsing-remitting multiple sclerosis.

The Phase 2 clinical trial, titled “A Placebo-Controlled Multi-Center Phase 2 Dose Finding Study of Ublituximab, a Third-Generation Anti-CD20 Monoclonal Antibody, in Patients with Relapsing Forms of Multiple Sclerosis,” is being led by Edward Fox, MD, PhD, clinical assistant professor at the University of Texas Medical Branch in Round Rock, and director of the Multiple Sclerosis Clinic of Central Texas. The trial is currently recruiting about 40 participants.

TG-1101 (ublituximab) is a novel monoclonal antibody designed to target a specific protein (CD20) found on mature B-lymphocytes. Although therapies for multiple sclerosis (MS) aiming at B-cell depletion have proven efficacious, this is the first company-sponsored trial evaluating TG-1101 for its safety, tolerability and efficacy in autoimmune diseases.

Particularly, the researchers will determine a TG-1101 optimal dose, focusing on decreasing infusion times, and at each dosing group they will monitor TG-1101 for safety, tolerability and B-cell depletion. Established MS efficacy endpoints will also be evaluated.

“We are excited to launch our first study in the treatment of patients with relapsing forms of MS, an area of significant unmet medical need. B-cell depletion therapy has recently proven to be highly effective in the treatment of both relapsing and progressive forms of MS,” Michael S. Weiss, the company’s executive chairman and interim chief executive officer said.

TG Therapeutics specializes in developing therapies for autoimmune diseases and B-cell malignancies.