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TG Therapeutics, Inc. Comments on Unusual Trading Activity
Oct 28, 2013
The Company reiterates its guidance from its last presentation at BioCentury's NewsMakers in the
- Commencement of combination trials for TG-1101, the Company's novel glycoengineered CD20, in combination with novel small molecule BTK and/or PI3K delta inhibitors; and
- Presentation of Phase 1 dose escalation data for TGR-1202, the Company's novel PI3K delta inhibitor.
With respect to TG-1101, the Company is committed to aggressively pursuing novel combinations that it believes can dramatically improve patient care in terms of both efficacy and safety, and to be at the forefront of this paradigm shift in the treatment of B-cell lymphoma and leukemia. The Company plans to commence such studies this quarter and, pending satisfactory safety and efficacy, to move rapidly into registration trials in 2014.
With respect to TGR-1202, the Company has completed dosing in the 800mg QD cohort and has now initiated dosing of the 1200mg QD cohort. At the
With respect to TGR-1202, the Company reiterates the data presented at the BioCentury conference:
- Preliminary PK analysis confirms that TGR-1202 can be dosed once per day with significant accumulation and a steady state half-life that exceeds 24 hours;
- No drug related liver toxicity has been observed, an adverse event generally associated with competitive PI3K delta inhibitors; and
- Investigators have reported what they believe to be signs of PI3K delta related activity (i.e. lymphocytosis and nodal reductions)
"We have been quite busy planning and preparing for our first combination studies of TG-1101 with BCR targeted kinase inhibitors, our core development strategy for TG-1101, and believe in the great potential for our novel glycoengineered CD20 in these novel combinations, stated
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Cautionary Statement
Some of the statements included in this press release, particularly those anticipating future clinical trials and business prospects for TG-1101 and TGR-1202 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 and TGR-1202; the risk that early pre-clinical and clinical results that supported our decision to move forward with TG-1101 and TGR-1202 will not be reproduced in additional patients or in future studies; the risk that TGR-1202 will not produce satisfactory safety and efficacy results to
warrant further development following 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; 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: 212.554.4484 Email: ir@tgtxinc.com
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