TG Therapeutics Announces Phase I Study of Novel BTK inhibitor, TG-1701, in Patients with Relapsed or Refractory B-cell Malignancies is Open for Enrollment
Tue November 13, 2018 7:30 AM|GlobeNewswire|About: TGTX
First dose cohort fully enrolled
First patient enrolled with relapsed/refractory Mantle Cell Lymphoma achieved Partial Response (PR) to lowest dose being tested
NEW YORK, Nov. 13, 2018 (GLOBE NEWSWIRE) -- TG Therapeutics (TGTX), Inc. (NASDAQ: TGTX) today announced the first Company sponsored Phase I study of its novel, orally available and covalently-bound Bruton Tyrosine Kinase (BTK) inhibitor, TG-1701, is open for enrollment for patients with relapsed or refractory B-cell malignancies. The first cohort evaluating TG-1701 at a dose of 100 mg once-daily has been fully enrolled, and the first patient enrolled, a patient with relapsed/refractory Mantle Cell Lymphoma (MCL), achieved a partial response (PR) at the first efficacy assessment. The remaining two patients are too early to evaluate.
This Phase I open label trial is designed to assess the safety, pharmacokinetics, pharmacodynamics and efficacy of TG-1701 in patients with non-Hodgkin’s Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL). The trial is first evaluating TG-1701 as a single agent, with subsequent cohorts designed to evaluate the triple combination of TG-1701 with ublituximab, the Company's novel glycoengineered anti-CD20 monoclonal antibody and umbralisib, the Company's novel PI3K delta inhibitor, the combination referred to as “U2”. The primary objective of the study is to determine the Maximum Tolerated Dose (MTD) of TG-1701, with secondary objectives including evaluation of efficacy. The study is being led by Constantine Tam, M.D., Director of Hematology, St. Vincent’s Hospital and Consultant Hematologist, Peter MacCallum Cancer Center, in Australia.
Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer stated, “We are extremely pleased to announce the commencement of our first TG sponsored trial of TG-1701, our proprietary BTK inhibitor which was licensed from Jiangsu Hengrui earlier this year. The pre-clinical data presented at the European Hematology Association (EHA) annual congress this past summer on TG-1701 showed a highly selective kinase profile giving us confidence in its clinical potential.” Mr. Weiss continued, “We are excited to see the study is off to a strong start with the first cohort rapidly enrolled and the first patient achieving a PR at our lowest evaluated dose. Seeing early activity should accelerate our ability to identify a dose appropriate for use in combination with U2 and for expansion cohorts. We look forward to seeing more data from TG-1701 in 2019 and start
