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TG Therapeutics, Inc. Launches Phase 1/2 "Triple-Therapy" Study With TGR-1202 + TG-1101 + the PD-1 Checkpoint Inhibitor Pembrolizumab in Patients With Advanced Chronic Lymphocytic Leukemia (CLL) at the University of Pennsylvania's Abramson Cancer Center
Sep 09, 2015
"We are very excited about the launch of this combination study and its potential in treating patients with CLL. To date, engaging T-cells to fight CLL has been promising but has yet to produce the dramatic effects seen in other settings. We believe our proprietary TG-1101 plus TGR-1202 regimen in combination with T-cell enhancing therapies, like anti-PD-1, could significantly improve the outcomes for patients with CLL," stated
Dr.
The Phase 1 part of the study will evaluate the safety, tolerability, and appropriate dose of pembrolizumab when combined with TGR-1202 and TG-1101 in patients with advanced CLL. The Phase 2 part of the study will further evaluate the safety and effectiveness of the triple combination at the recommended Phase 2 dose.
This study is currently open to enrollment at the
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Cautionary Statement
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 business prospects for TG-1101, TGR-1202, 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, 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, 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 the results seen from the triple combination of TGR-1202, TG-1101 and pembrolizumab will not be sufficiently promising to warrant additional clinical testing with anti-PD-L1/anti-PD-1 anitbodies; the risk that trends observed which underlie certain assumptions of future performance of TGR-1202 will not continue, the risk that TGR-1202 will not produce satisfactory safety and efficacy results to warrant further development following the completion of the current Phase 1 study; 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
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CONTACT:Source:Jenna Bosco Director- Investor RelationsTG Therapeutics, Inc. Telephone: 212.554.4351 Email: ir@tgtxinc.com
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