Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics, stated, "We are extremely pleased to announce this research collaboration with the National Multiple Sclerosis Society and Dr. Lawrence Steinman to explore the use of TGR-1202 in pre-clinical models of progressive forms of MS. Our long-term vision has always included developing TGR-1202 in auto-immune diseases and it is research collaborations like this one that will help us identify the most appropriate targets for clinical evaluation." Mr. Weiss continued, "MS has rapidly become a core focus for our autoimmune R&D effort and we were excited to recently announce the commencement of our first Phase 3 clinical program, entitled ULTIMATE I and II, for TG-1101, our novel glycoengineered anti-CD20 monoclonal antibody, pursuant to a Special Protocol Assessment."
Lawrence Steinman, MD, George A. Zimmermann Professor and Professor of Pediatrics, Neurology and Neurological Sciences at Stanford University, commented, "The recent approval of ocrelizumab has proven that B-cell targeted therapy is a very attractive treatment option for progressive MS patients as well as those with relapsing MS. Umbralisib is a B-cell targeting agent that inhibits PI3K-delta, an enzyme that is essential for B-cell maturation and growth, providing a novel mechanism of action in treating patients with MS. We look forward to evaluating umbralisib's effect on our preclinical progressive MS models in hopes to move umbralisib closer to clinical development in MS."
Mark Allegretta, PhD, Associate Vice President of Commercial Research at the Society, stated, "We are hopeful that these proof of concept studies will support the rationale for further clinical development of TGR-1202 for progressive forms of MS, for which there are few treatment options." Mr. Allegretta continued, "TG Therapeutics is clearly committed to finding solutions for people with MS and we are pleased to work with a partner with the credibility and experience to carry this project forward. This exemplifies our effort to identify clinic-ready drug candidates to expand the pipeline of therapies being tested for use in MS."
About the National Multiple Sclerosis Society
The Society mobilizes people and resources so that everyone affected by multiple sclerosis can live their best lives as we stop MS in its tracks, restore what has been lost and end MS forever. Last year alone, through our comprehensive nationwide network of services, the Society devoted more than $100 million to connect approximately one million people affected by MS to the connections, information and resources they need. To move closer to a world free of MS, the Society also invested $42 million to support more than 380 new and ongoing research projects around the world. We are united in our collective power to do something about MS now and end this disease forever. Learn more at www.nationalMSsociety.org.
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. 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 also in 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.
Statements included in this press release, particularly those with respect to potential utility of TGR-1202 as a possible treatment option for patients with MS, anticipating the benefit of the early data seen in the Phase 2 MS trial, as well as anticipating the timing of the release of additional data from our Phase 2 MS trial and the timing of the first patient enrolled into our MS Phase 3 program 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: the risk that TGR-1202 will not be a viable treatment option for patients with MS, the risk that any preclinical results generated for TGR-1202 do not translate into successful results when and if TGR-1202 enters clinical studies for the treatment of MS; our ability to successfully and cost-effectively complete the MS Phase 2 trial; the risk that early clinical results that supported our decision to move forward will not be reproduced in additional patients in expansion cohorts or in the MS Phase 3 program; the risk that the clinical results from the MS Phase 3 program, will be not positive and/or will not support regulatory approval of TG-1101 for MS; the risk that TG-1101 will not have a differentiated profile from the other drugs in the class; the risk that some of the perceived attributes of TG-1101, in particular the infusion times and potential pricing advantages may not be incorporated into future plans; the risk that TGR-1202 does not prove to be an efficacious oral treatment option for patients with MS 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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Vice President- Investor Relations
TG Therapeutics, Inc.
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