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TG Therapeutics, Inc. Initiates A Phase I/II Clinical Trial Of Its Novel Third-Generation Anti-CD20 Monoclonal Antibody, Ublituximab, In Patients With Relapsed Or Refractory B-cell Non-Hodgkin's Lymphoma
Multi-Center Phase I/II Trial Led by Dr. Owen O'Connor, MD, PhD, Director, Center for Lymphoid Malignancies, New York Presbyterian Columbia Medical Center
TG Therapeutics to Host a Conference Call on Thursday, September 6 , 2012 at 8:30am EDT to Provide an Update on the Company's Business and Clinical Developments
NEW YORK, Sept. 5, 2012 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (TGTX) today announced that it has initiated a Phase I/II trial to evaluate the safety, tolerability and efficacy of ublituximab, the company's novel third-generation anti-CD20 monoclonal antibody, for patients with relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL) who were previously treated with rituximab (Rituxan®). This is the company's first clinical trial conducted in North America and the first trial of ublituximab in patients with NHL. Previously, at the 53
rd Annual American Society of Hematology meeting in December 2011, Phase I data from a trial conducted in France of ublituximab administered as a single agent to patients with relapsed and refractory Chronic Lymphocytic Leukemia (CLL) reported an objective response rate of 45%.
The trial, entitled "An Open Label Phase I/II Trial of the Efficacy and Safety of Ublituximab in Patients with B-cell Non-Hodgkin Lymphoma who have Relapsed or are Refractory After CD20 Directed Antibody Therapy," will enroll up to 36 patients in the Phase I dose escalation component. Once the optimal dose is determined, up to 77 patients total will be enrolled for the Phase II component and stratified by subtype of B-cell Lymphoma, including Follicular Lymphoma, Diffuse Large B-cell Lymphoma, Marginal Zone Lymphoma and other NHL subtypes. All enrolled patients will be relapsed or refractory to Rituxan® or a Rituxan® containing regimen, and in most cases multiple other lines of therapy.
"Ublituximab has demonstrated profound and sustained B-cell depletion in multiple pre-clinical NHL models, as well as impressive single agent activity in patients with relapsed/refractory CLL, and could now represent an important therapy for patients relapsed from or refractory to prior rituximab. We are excited to evaluate the role of ublituximab in this NHL patient population which is in great need of more effective therapies," stated Dr. Owen O'Connor, Professor of Medicine and Director, Center for Lymphoid Malignancies at New York Presbyterian Columbia Medical Center, and principle investigator of the trial.