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TG Therapeutics continues with leukaemia trial after all-clear

Tuesday, November 22, 2016 8:02
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TG Therapeutics Inc (NASDAQ:TGTX) has been given the all-clear to continue its phase III trial of a combination treatment for Chronic Lymphocytic Leukaemia (CLL).

The US Data Safety Monitoring Board (DSMB), an independent body,  reviewed the cumulative safety data from the ongoing Unity-CLL trial and found no safety concerns for Ublituximab/TGR-1202.

“We are encouraged by the positive outcome of the first DSMB safety review, especially since over two-thirds of the patients currently enrolled in the study are treatment naive CLL patients.” 

Last year, a rival company’s trial of a drug for naive CLL patients was halted after liver toxicity developed in many of those treated.

“Given those findings, we are pleased to report that the DSMB did not find any safety concerns and recommended the study continue without modification,” said Michael S Weiss, executive chairman.

“The target remains for full enrolment of patients for the Unity-CLL trial by the first half of 2018.” 

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