TG Therapeutics Announces Positive DSMB Recommendation For Continuation Of The UNITY-CLL Phase 3 Trial

NEW YORK, Nov. 22, 2016 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), today announced that the independent Data Safety Monitoring Board (DSMB) providing oversight for the UNITY-CLL Phase 3 trial reviewed the cumulative safety data from the ongoing clinical study and informed the Company that it has identified no safety concerns, and recommended the continuation of the study with no modifications.  Per the protocol's pre-specified DSMB charter, the DSMB is scheduled to meet approximately every 6-9 months to review cumulative safety data.  "We are encouraged by the positive outcome of the first DSMB safety review, especially since over two-thirds of the patients currently enrolled in the study are treatment naive CLL patients.  Many may recall, as reported by Dr. Jennifer Brown at last year's ASH meeting, and published earlier this year in Blood, that idelalisib in treatment naive CLL patients was observed to cause rapid (most within <5 weeks) and profound (Grade 3/4) liver toxicity in approximately 50% of the patients treated.  Given those findings, we are pleased to report that the DSMB did not find any safety concerns and recommended the study continue without modification," stated Michael S. Weiss, the Company's Executive Chairman and Interim Chief Executive Officer.  Mr. Weiss continued, "We are also excited to report that the UNITY-CLL study continues to enroll well and we are still targeting completion of enrollment in the first half of 2018."


TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is developing two therapies targeting hematological malignancies and autoimmune diseases. TG-1101 (ublituximab) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing TGR-1202, an orally available PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B-lymphocytes. Both TG-1101 and TGR-1202 are in clinical development for patients with hematologic malignancies, with TG-1101 recently entering clinical development for autoimmune disorders. The Company also has preclinical programs to develop IRAK4 inhibitors, BET inhibitors, and anti-PD-L1 and anti-GITR antibodies. TG Therapeutics is headquartered in New York City.

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