NEW YORK, NY, USA I August 07, 2018 I TG Therapeutics, Inc. (NASDAQ: TGTX) today announced that target enrollment in the ULTIMATE I and II Phase 3 trials has been achieved. ULTIMATE I and II are two independent Phase 3 clinical trials evaluating the safety and efficacy of ublituximab (TG-1101), the Company’s glycoengineered anti-CD20 monoclonal antibody, as compared to teriflunomide, in patients with relapsing forms of Multiple Sclerosis (RMS). These studies are being led by Dr. Lawrence Steinman, of Stanford University and are being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). While target enrollment has been reached, in order to provide an opportunity for patients already identified to participate, enrollment is expected to continue until mid-September.
Michael S. Weiss, Executive Chairman and Chief Executive Officer, stated, “We are extremely pleased to have achieved target enrollment in the ULTIMATE Phase 3 trials approximately 9 months ahead of originally anticipated, which may enable an accelerated readout of the results possibly as early as the middle of 2020.” Mr. Weiss continued, “We’ve presented several early cuts of data from our Phase 2 MS trial of ublituximab at key conferences over the last year and believe the safety and activity demonstrated thus far support our belief that the ULTIMATE Phase 3 studies will be positive. We look forward to presenting the final data from our Phase 2 MS study at a major medical conference before year end. With the Phase 3 MS studies completing enrollment earlier than expected, we now have multiple pivotal data read-outs projected to occur between now and mid-2020 from both our cancer and MS programs.”
ABOUT THE ULTIMATE TRIALS
ULTIMATE I and ULTIMATE II are two independent Phase 3 trials. Each trial is a global, randomized, multi-center, double-blinded, double-dummy, active-controlled study comparing ublituximab (TG-1101) to teriflunomide in subjects with relapsing forms of Multiple Sclerosis (RMS). The primary endpoint for each study is Annualized Relapse Rate (ARR) following 96 weeks of treatment. Additional information on these clinical trials can be found at www.clinicaltrials.gov.
ABOUT TG THERAPEUTICS, INC.
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. Ublituximab (TG-1101) 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 umbralisib (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 ublituximab and umbralisib, or the combination of which is referred to as “U2”, are in Phase 3 clinical development for patients with hematologic malignancies, with ublituximab also in Phase 3 clinical development for Multiple Sclerosis. Additionally, the Company has recently brought its anti-PD-L1 monoclonal antibody into Phase 1 development and aims to bring additional pipeline assets into the clinic in the future. TG Therapeutics is headquartered in New York City.
SOURCE: TG Therapeutics
Post Views: 27
NEW YORK, NY, USA I August 07, 2018 I TG Therapeutics, Inc. (NASDAQ: TGTX) today announced that target enrollment in the ULTIMATE I and II Phase 3 trials has been achieved. ULTIMATE I and II are two independent Phase 3 clinical trials evaluating the safety and efficacy of ublituximab (TG-1101), the Company’s glycoengineered anti-CD20 monoclonal antibody, as compared to teriflunomide, in patients with relapsing forms of Multiple Sclerosis (RMS). These studies are being led by Dr. Lawrence Steinman, of Stanford University and are being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). While target enrollment has been reached, in order to provide an opportunity for patients already identified to participate, enrollment is expected to continue until mid-September.
Michael S. Weiss, Executive Chairman and Chief Executive Officer, stated, “We are extremely pleased to have achieved target enrollment in the ULTIMATE Phase 3 trials approximately 9 months ahead of originally anticipated, which may enable an accelerated readout of the results possibly as early as the middle of 2020.” Mr. Weiss continued, “We’ve presented several early cuts of data from our Phase 2 MS trial of ublituximab at key conferences over the last year and believe the safety and activity demonstrated thus far support our belief that the ULTIMATE Phase 3 studies will be positive. We look forward to presenting the final data from our Phase 2 MS study at a major medical conference before year end. With the Phase 3 MS studies completing enrollment earlier than expected, we now have multiple pivotal data read-outs projected to occur between now and mid-2020 from both our cancer and MS programs.”
ABOUT THE ULTIMATE TRIALS
ULTIMATE I and ULTIMATE II are two independent Phase 3 trials. Each trial is a global, randomized, multi-center, double-blinded, double-dummy, active-controlled study comparing ublituximab (TG-1101) to teriflunomide in subjects with relapsing forms of Multiple Sclerosis (RMS). The primary endpoint for each study is Annualized Relapse Rate (ARR) following 96 weeks of treatment. Additional information on these clinical trials can be found at www.clinicaltrials.gov.
ABOUT TG THERAPEUTICS, INC.
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. Ublituximab (TG-1101) 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 umbralisib (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 ublituximab and umbralisib, or the combination of which is referred to as “U2”, are in Phase 3 clinical development for patients with hematologic malignancies, with ublituximab also in Phase 3 clinical development for Multiple Sclerosis. Additionally, the Company has recently brought its anti-PD-L1 monoclonal antibody into Phase 1 development and aims to bring additional pipeline assets into the clinic in the future. TG Therapeutics is headquartered in New York City.
SOURCE: TG Therapeutics
Post Views: 27
