Trovagene completes first dosing in Phase 1b/2 trial of leukemia candidate
Trovagene completed the first dose cohort in its Phase 1b/2 clinical trial of PCM-075, a highly-selective Polo-like Kinase 1 Inhibitor, in combination with LDAC, in Acute Myeloid Leukemia. Patients eligible for Phase 1b have relapsed or refractory disease and may have received as many as three prior regimens for treatment of their AML. The combination of PCM-075 and LDAC was well tolerated in all patients. The independent Safety Review Committee has recommended escalating to the second dose cohort of three patients at PCM-075 at 18 mg/m2, a 50% increase, in combination with LDAC. The PCM-075 dose level may be increased by 50% increments in successive cohorts of three patients until a maximum tolerated dose or recommended Phase 2 dose is achieved. In Phase 2 the MTD or RP2D will be administered to 32 patients to evaluate preliminary antitumor activity and to continue to evaluate the safety and tolerability of PCM-075 in combination with standard-of-care chemotherapy.