- TG Therapeutics (NASDAQ:TGTX) is up 9% premarket on average volume in response to its announcement that an interim analysis of its Phase 3 clinical trial assessing the combination of TG-1101 (ublituximab) and TGR-1202 and each candidate alone in patients with chronic lymphocytic leukemia (CLL).
- The analysis, conducted by the independent Data Safety Monitoring Board, showed the contribution of the combination has been established and is safe so recruitment in the single agent arms will cease. Going forward, the trial will assess the combination against a control arm of obinutuzumab (Roche's GAZYVA) plus chlorambucil.
- CEO Michael S. Weiss says, “We are extremely pleased that the DSMB has once again found no safety concerns that would require modifying the study. This is particularly comforting when we consider that the safety population now includes over 60 front-line CLL patients treated for more than 6 weeks with TGR-1202 alone or in combination with TG-1101. As most who have followed this area will recall, treatment-naïve CLL patients appear to be exquisitely sensitive to the autoimmune mediated side effects of idelalisib (Gilead's ZYDELIG), with approximately 50% experiencing Grade 3/4 liver toxicity by week 6 in a published study."
- Now read: Ovid Therapeutics Continues Streak Of BioPharm Companies Going Public
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