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TG Therapeutics, Inc. Initiates First-In-Human, Phase I Clinical Trial For Its Novel, Highly Specific PI3K-Delta Inhibitor, TGR-1202, In Patients With Hematologic Malignancies

Stocks in this article: TGTX

NEW YORK, Jan. 8, 2013 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (TGTX) today announced that it has initiated a Phase I, open label, multi-center, first-in-human clinical trial of its novel PI3K delta inhibitor, TGR-1202, in patients with hematologic malignancies.

The study, entitled "A Phase I Dose Escalation Study Evaluating the Safety and Efficacy of TGR-1202 in Patients with Relapsed or Refractory Hematologic Malignancies," is being run in collaboration with the Sarah Cannon Research Institute in Nashville, TN, and will enroll approximately 30 patients during the initial dose escalation phase, followed by up to an additional 30 patients in an expansion phase once the optimal dose has been determined. Enrollment is open to patients with relapsed or refractory Non-Hodgkin's Lymphoma ("NHL"), Chronic Lymphocytic Leukemia ("CLL"), and Peripheral T-Cell Lymphoma ("PTCL"). Michael R. Savona, MD, Director of Leukemic Research, Sarah Cannon Research Institute, will act as Study Chair for the Phase I study.

"Having received FDA clearance of our IND only last week, the launch of this first-in-human Phase I study of TGR-1202 demonstrates our team's commitment to rapidly initiating and executing our clinical programs," stated Michael S. Weiss, Executive Chairman and Interim CEO of TG Therapeutics. "Inhibition of PI3K delta has demonstrated remarkable potential as a therapeutic strategy for the treatment of patients with hematologic malignancies and we are excited to begin working with Dr. Savona and the research team at Sarah Cannon and other centers across the United States to begin assessing the clinical potential of TGR-1202."

The commencement of this Phase I study of TGR-1202 marks the third clinical trial for TG Therapeutics, following the initiation of two Phase I/II clinical trials last year for TG-1101 (ublituximab), the Company's novel anti-CD20 monoclonal antibody, also under development for hematologic malignancies.


TGR-1202 is a highly specific, orally available, PI3K delta inhibitor, targeting the delta isoform with nanomolar potency and several fold selectivity over the alpha, beta, and gamma isoforms of PI3K. Inhibition of PI3K delta signaling with TGR-1202 has demonstrated activity in numerous pre-clinical models and primary cells from patients with hematologic malignancies. TG Therapeutics, Inc. and Rhizen Pharmaceuticals, SA are jointly developing TGR-1202 on a worldwide basis, excluding India.

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