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NEW YORK, Oct. 28, 2013 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (Nasdaq:TGTX), reports that in view of the unusual market activity in the Company's stock price, NASDAQ MarketWatch has contacted the company in accordance with its usual practice. While the Company does not typically comment on unusual market activity, TG Therapeutics confirms that it is not aware of any developments that would merit such trading activity.
The Company reiterates its guidance from its last presentation at BioCentury's NewsMakers in the Biotech Industry Conference on September 27, 2013 in which it guided that the next major milestones for the Company are:
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 American Society of Hematology Meeting ("ASH") in December 2013, the Company intends to present a detailed pharmacokinetic ("PK") and safety analysis for all patients through the 1200mg cohort and efficacy through the 800mg cohort (the 1200mg cohort patients will be too early to evaluate at ASH).
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 Michael S. Weiss, Executive Chairman and Interim Chief Executive Officer. He continued, "Likewise, we and our clinical investigators for TGR-1202 are extremely optimistic about its potential and are encouraged by the level of activity seen thus far that appears to be mechanistically related and dose related. We all look forward to the presentation of the data at ASH and to continued dose escalations."