The Phase 1 study involved 32 patients with either acute myelogenous leukemia (AML) or acute lymphoblastic leukemia (ALL), and will determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), safety, tolerability, clinical activity and pharmacokinetics of TH-302 in patients with advanced leukemia.
In the study, patients were administered with the drug dosages ranging from 120mg/m2 to 550 mg/m2, as a 30-60 minute intravenous infusion daily for 5 days every 21 days, and found that patients established a maximum tolerated daily dose at 460 mg/m2.
The preclinical study of TH-302 also showed that TH-302 demonstrated potent anti-leukemia activity and hypoxia-dependent cytotoxicity against primary ALL and AML mice models.
MD Anderson Cancer Center Department of Leukemia associate professor Marina Konopleva said the study findings reported a reduction in blasts in refractory advanced leukemia patients treated with TH-302 .
”Ongoing preclinical investigations have demonstrated that TH-302 is active as a monotherapy and demonstrate synergistic activity in combination with multiple chemotherapies. We are excited to continue further clinical investigations," Konopleva added.