NEW YORK, Jan. 19, 2016 (GLOBE NEWSWIRE) — TG Therapeutics, Inc. (Nasdaq:TGTX) announced today its key corporate goals and objectives for 2016, which include the following:
- Aggressively recruit into the GENUINE Phase 3 Clinical Trial of TG-1101 in combination with ibrutinib, which is now open in over 150 sites, with the goal of completing enrollment by YE16
- Aggressively enroll into the UNITY-CLL combination Phase 3 clinical trial, of the Company’s proprietary combination of TG-1101 plus TGR-1202 (aka “TG-1303”)
- Commence the UNITY- DLBCL Phase 2b/3 clinical trial
- Initiate a Phase 1/2 clinical trial in Multiple Sclerosis (MS)
- Commence a registration trial for iNHL in the 2H16
- Present updated data on the Phase 1 and 2 clinical trials at major hematology/oncology conferences during 2016
“We enter 2016 with great optimism for the Company and our product candidates and the prospect of developing best-in-class treatment options for patients with B-cell malignancies. As each year passes we become more convinced that controlling key components of combination treatments and offering package pricing will be critical to ensuring all patients have access to the best care possible,” stated Michael S. Weiss, the Company’s Executive Chairman and Interim CEO. Mr. Weiss continued, “The objectives we have set for 2016 will mark a clear transformation for TG, with year-end 2016 seeing at least four ongoing registration directed clinical trials in oncology, commencement of our MS program, and most importantly, completion of enrollment into our first Phase 3 study, setting the stage for the possible launch of our first product in late 2017.”
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. 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. The Company also has a pre-clinical program to develop IRAK4 inhibitors, as well as an antibody research program to develop anti-PD-L1 and anti-GITR antibodies. TG Therapeutics is headquartered in New York City.
Some of the statements included in this press release, particularly those with respect to anticipating future clinical trials, the timing of commencing or completing such trials and possible success of those trials and business prospects for TG-1101, TGR-1202, TG-1303, the IRAK4 inhibitor program, and the anti-PD-L1 and anti-GITR antibodies may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete pre-clinical and clinical trials for TG-1101, TGR-1202, TG-1303, the IRAK4 inhibitor program and the anti-PD-L1 and anti-GITR antibodies; the risk that early pre-clinical and clinical results that supported our decision to move forward with TG-1101, TGR-1202, TG-1303, the IRAK4 inhibitor program and the anti-PD-L1 and anti-GITR antibodies will not be reproduced in additional patients or in future studies; the risk that trends observed which underlie certain assumptions of future performance of TGR-1202 and TG-1303 will not continue, the risk that TGR-1202 or TG-1303 will not produce satisfactory safety and efficacy results to warrant further development following the completion of the current Phase 1 studies; the risk that the combination of TG-1303, will not prove to be a safe and efficacious backbone for triple and quad combination therapies; the risk that the data (both safety and efficacy) from future clinical trials will not coincide with the data produced from prior pre-clinical and clinical trials; the risk that trials will take longer to enroll than expected; our ability to achieve the milestones we project over the next year; our ability to manage our cash in line with our projections, and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
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CONTACT: CONTACT: Jenna Bosco Director- Investor Relations TG Therapeutics, Inc. Telephone: 212.554.4351 Email: email@example.com