TG Therapeutics Initiates First Combination Clinical Trial Of TG-1101, TGR-1202

(RTTNews) - TG Therapeutics Inc. (TGTX) announced Monday that it has initiated a multi-center, Phase I trial to evaluate the safety and efficacy of the combination of TG-1101 (ublituximab) and TGR-1202 for patients with relapsed and/or refractory Chronic Lymphocytic Leukemia or CLL and non-Hodgkin's Lymphoma or NHL.

This will be the first clinical trial evaluating the combination of TG-1101, the Company's novel glycoengineered anti-CD20 monoclonal antibody, and TGR-1202, the Company's novel, once per day, PI3K Delta inhibitor. In this study, dosing of TGR-1202 will commence at 800mg once per day (or QD) with dose escalation proceeding in a 3+3 design, the company noted.

According to the company, the trial, entitled "A Multi-center Phase I/Ib Study Evaluating the Efficacy and Safety of TG-1101 (Ublituximab), a novel Glycoengineered Anti-CD20 Monoclonal Antibody, in Combination with TGR-1202, a Novel PI3k Delta Inhibitor, in Patients with B-cell Malignancies," will enroll CLL and NHL patients whose disease is relapsed from or refractory to prior therapies, including prior anti-CD20 monoclonal antibodies, PI3K Delta inhibitors, and/or BTK inhibitors.

In addition, TG Therapeutics announced that it has opened its first expansion cohort in its ongoing single agent Phase 1 dose escalation study of TGR-1202. The expansion cohort will enroll additional patients at the 800mg QD dose level. As a maximum tolerated dose has not been reached, dose escalation continues in this study. To date, the Company has not observed any TGR-1202 drug-related liver toxicity.

At the upcoming American Society of Hematology Meeting in December 2013, the company said it intends to present detailed pharmacokinetic and safety data for all patients in the ongoing single agent study of TGR-1202 through the 1200mg QD cohort as well as efficacy data through the 800mg QD dose escalation cohort.