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June 13, 2014
05:38 EDTTGTXTG Therapeutics reports compelling clinical data from TG-1101 Phase 2 study
TG Therapeutics announced preliminary clinical results from its ongoing Phase 2 study of TG-1101, the company's novel glycoengineered anti-CD20 monoclonal antibody, in combination with ibrutinib. The overall response rate, or ORR, at the first planned efficacy assessment for the 10 evaluable patients was 90%. Of the 28 patients enrolled on study to date, including patients with high risk CLL, no patients have progressed while on the combination, with patients on study now for upwards of 5 months. TG-1101 in combination with ibrutinib was well tolerated in the 28 patients evaluable for safety, with Day 1 infusion related reactions, or IRR, being the most frequently reported adverse event for TG-1101. Updated data presented at the EHA meeting demonstrates an 89% nodal response rate with 8/9 CLL patients now achieving a nodal or partial response on TGR-1202 monotherapy at doses greater than or equal to 800 mg.
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September 15, 2014
14:10 EDTTGTXTG Therapeutics SPA for CLL study earlier than expected, says Ladenburg
Ladenburg said TG Therapeutics reached an agreement with the FDA regarding a Special Protocol Assessment, or SPA, for a trial of its combo treatment for Chronic Lymphocytic Leukemia, or CLL, "quite ahead" of the firm's December expectation. The firm believes there is a relatively high probability for TG's combo to meet the specified primary endpoint and increased its price target on the stock to $22 from $18.
07:03 EDTTGTXTG Therapeutics announces SPA agreement with FDA for Phase 3 trial of TG-1101
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