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TG Therapeutics, Inc. Announces Presentation of Encouraging Clinical Activity of TGR-1202 in an Ongoing Multi-Center Phase I Clinical Study
Dec 09, 2013
- All evaluable CLL patients treated with once daily TGR-1202 at 800 mg exhibited significant nodal reductions with 3 of 4 patients achieving > 50% nodal partial response
- TGR-1202 appears well tolerated; no hepatic toxicity observed; limited GI side effects with no Grade 3 or greater GI toxicity
- Activity correlates with higher drug exposure; linear pharmacokinetics observed through 1200 mg QD dose cohort
- Half-life in excess of 24 hours supports once daily dosing
- 1200mg QD cohort cleared without defining an MTD; dosing continues at 1800 mg
The multi-center Phase I study is being conducted in
Today's poster presentation includes data from 22 patients with relapsed and refractory hematologic malignancies treated with TGR-1202 at doses ranging from 50 mg to 1200 mg QD. Evaluable patients included CLL (10), indolent
Key data presented from the study include:
Safety and Tolerability
TGR-1202 appears to be well-tolerated with no dose-related trends in adverse events observed. Grade 3 events have been limited and no patient has discontinued study drug due to an adverse event. Notably, of the 22 patients evaluable for safety, no hepatotoxicity or Grade 3 or greater GI side effects were observed. No MTD has been achieved and dose escalation is ongoing, now dosing patients at 1800 mg QD.
Pharmacokinetics
Pharmacokinetic evaluation for TGR-1202 displays linear kinetics through 1200 mg QD. TGR-1202 was found to be rapidly absorbed (Tmax of approximately 2 hours) with an estimated effective steady state half-life (t½) exceeding 24 hours which supports once daily (QD) oral administration of TGR-1202.
Clinical Activity
Nineteen patients were evaluable for efficacy, which included all patients up through the 800 mg QD cohort. Patients in the 1200mg QD cohort were too early to evaluate.
Nodal responses were observed at the 800 mg cohort. In this cohort, 100% of the evaluable CLL patients demonstrated significant nodal reductions of which 3 of 4 patients achieved a nodal partial response ( > 50% reduction) at the first response assessment. In addition to the activity observed in CLL, a heavily pre-treated patient (6 prior lines of therapy) with refractory Germinal Cell DLBCL, an aggressive form of
As of
Enrollment into the study continues, with an expansion cohort recently opened at 800 mg QD as dose escalation continues.
Dr.
The poster, entitled "A Phase I Dose Escalation Study of TGR-1202, a Novel PI3K-delta Inhibitor for Patients with Relapsed or Refractory Hematologic Malignancies," is being presented on
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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 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:Source:Jenna Bosco Director- Investor RelationsTG Therapeutics, Inc. Telephone: 212.554.4484 Email: ir@tgtxinc.com
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