TG Therapeutics has begun a first-in-human, Phase I trial of TGR-1202 in patients suffering from hematologic malignancies such as relapsed or refractory Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia and Peripheral T-Cell Lymphoma.
TGR-1202 is a novel, highly specific, orally available PI3K delta inhibitor that targets the delta isoform with nanomolar potency and several fold selectivity over the alpha, beta, and gamma isoforms of PI3K.
TG Therapeutics executive chairman and interim CEO Michael Weiss said the launch of the first-in-human Phase I study of TGR-1202 is followed by the FDA clearance of the company's IND last week.
"Inhibition of PI3K delta has demonstrated remarkable potential as a therapeutic strategy for the treatment of patients with hematologic malignancies and we are excited to begin working with Dr Savona and the research team at Sarah Cannon and other centers across the United States to begin assessing the clinical potential of TGR-1202," Weiss said.
The open label, multi-centre study, which is being conducted in collaboration with the Sarah Cannon Research Institute, is expected enrol around 30 patients during the initial dose escalation phase, and an extra 30 patients in an expansion phase after determination of the optimal dose.
The TGR-1202 Phase I study of is the third trial for TG Therapeutics, as the company has already commenced two Phase I/II trials last year for its novel anti-CD20 monoclonal antibody, also under development for hematologic malignancies.