TG Therapeutics launches first clinical trial in multiple sclerosis for TG-1101

This is the first company sponsored clinical trial evaluating the safety, tolerability, and efficacy of TG-1101 in autoimmune diseases.

The Company is also supporting an investigator-sponsored study at John’s Hopkins University Medical Center that is currently enrolling patients with Neuromyelitis Optica (NMO), a related demyelinating disease similar to MS but of the optic nerve and spinal cord.

The study, entitled "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, Director of the Multiple Sclerosis Clinic of Central Texas and Clinical Assistant Professor at the University of Texas Medical Branch in Round Rock, TX.

The primary objective of the study is to determine the optimal dosing regimen for TG-1101 with a focus on accelerating infusion times. In addition to monitoring for safety and tolerability at each dosing cohort, B-cell depletion and established MS efficacy endpoints will also be evaluated.

Michael S. Weiss, the Company’s Executive Chairman and Interim Chief Executive Officer commented on the news, "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. TG-1101 is a potent b-cell depleting agent; in our oncology studies TG-1101 has demonstrated an ability to cause rapid and profound B-cell depletion with a favorable safety profile.

Additionally, early B-cell depletion data from our NMO study appears to confirm TG-1101’s potent B-cell depleting effects."

Mr. Weiss continued, "This Phase 2 trial has been uniquely designed to evaluate rapid administration schedules for TG-1101, potentially allowing us to offer a very attractive and convenient treatment option for patients. We look forward to collaborating with Dr. Fox and the other investigators in this important study and launching a Phase 3 trial for TG-1101 in MS next year."

Edward Fox, MD, PhD, Director of the Multiple Sclerosis Clinic of Central Texas and Clinical Assistant Professor at the University of Texas Medical Branch in Round Rock, TX and Study Chair of the Phase 2 study added, "We look forward to collaborating with TG Therapeutics on this first clinical trial of TG-1101 in patients with relapsing forms of MS.

"An increasing amount of data strongly suggests a critical role for B-cells in the pathophysiology of MS. B-cell depletion therapy through the use of an anti-CD20 monoclonal antibody has the potential to offer a highly effective treatment option that has an acceptable safety and tolerability profile."