TG-1101 Well Tolerated and Induced 50% Overall Response Rate (5/10) 40% of Rituximab-Refractory Patients (2/5) Achieve a Complete Response 100% of Marginal Zone Lymphoma Patients (3/3) Achieve a Complete or Partial Response
NEW YORK, June 3, 2013 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (TGTX) today announced preliminary results from a Phase 1 clinical study of single-agent ublituximab (TG-1101) in patients with rituximab relapsed and/or refractory Non-Hodgkin's Lymphoma (NHL), presented at the American Society of Clinical Oncology Meeting on June 2, 2013. The poster presentation, entitled "A Phase I dose-escalation trial of ublituximab (TG-1101), a novel anti-CD20 monoclonal antibody (mAb), for rituximab relapsed/refractory B-cell lymphoma patients," was presented by Principal Investigator, Dr. Owen A. O'Connor of Columbia University (Abstract #8575). The poster is available on the Company's website ( www.tgtherapeutics.com ) under the quick links section entitled "Publications."
PRELIMINARY DATA FROM THE DOSE ESCALATION PORTION OF PHASE I/II STUDYThe poster presentation highlighted preliminary safety and efficacy data from 4 cohorts of 3 patients each at dose levels of 450mg, 600mg, 900mg and 1200mg. All 12 patients (7 Follicular (FL), 3 Marginal Zone (MZL) and 2 Mantle Cell Lymphoma (MCL)) were evaluable for safety while 10/12 patients were evaluable for efficacy (2 patients were too early for efficacy evaluation (TETE)). Among these 12 patients, the median number of prior therapies was 4 (range 2-6), with 100% and 75% of patients receiving at least 1 and 2 prior rituximab-based regimens, respectively. Fifty percent (50%) of enrolled patients were considered refractory to a rituximab-based regimen, defined as progressing on or within 6 months following their last rituximab-based regimen. Ublituximab (TG-1101) was well tolerated with the majority of adverse events being Grade 1 and 2, with minimal Infusion Related Reactions (IRR) observed. Only one Grade 3 event was reported. All 12 patients completed all planned infusions. Infusion time decreased significantly from the first (mean of 4 hours) to the fourth and maintenance infusions (mean of ~ 1.5 hours).
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