Clinical-stage oncology company Prescient Therapeutics (ASX:PTX) has announced H. Lee Moffitt Cancer Centre in Florida has dosed the first patient to PTX’s Phase 1b/2 clinical trial in acute myeloid leukemia (AML).
The clinical trial is being led by Principal Investigator, Dr Jeffrey Lancet, Professor of Oncologic Sciences at the Moffitt and University of South Florida. He is Chair of the Department of Malignant Hematology at Moffitt.
Moffitt is the third largest cancer centre in the US and is an NCI-designated comprehensive cancer center.
The clinical trial will be conducted with PTX’s Akt inhibitor, PTX-200, plus cytarabine in refractory or relapsed AML. Approximately 18 patients will be recruited in the Phase 1b stage of the trial.
According to Professor Lancet, “I am excited to commence recruitment on this important trial. PTX-200 has shown some promising activity and the proposed study will frame our direction as we progress further down the clinical trial process with PTX-200.”
Prescient CEO and Managing Director, Steven Yatomi-Clarke, said: “Professor Lancet is an authority on AML with deep clinical experience across many AML treatment regimes. We are pleased to be working so closely with him.”
The Phase 1b study is an open-label dose escalation study, using a standard design for dose escalation and for determining the safe dose to be used in combination with cytarabine in the Phase 2 part of the study. Up to four dose levels will be evaluated, with the initial dose level of 25 mg/m2 PTX-200. Each dose level will be increased by 10 mg/m2 . Doses will be administered for a maximum of four 21-day cycles. Safety and clinical activity will be evaluated at the end of each cycle. PTX will also be evaluating the effect of PTX- 200 on Akt signaling, inhibition of proliferation (growth) and induction of apoptosis (cell death).