Prescient (ASX: PTX) expands its PTX-200 trial in AML patients

Highlights

• Patient achieved complete remission at 45mg/m² PTX-200 + cytarabine
• 4th complete remission on relapsed & refractory AML study
• No dose limiting toxicities were reported at 45mg/m²
• The cohort to be expanded to three additional patients at same dose level.
• Follows a partial response confirmed at the previous cohort of 35mg/m²

Prescient Therapeutics Limited (ASX:PTX), a clinical-stage oncology company, has taken another step towards advancing its study of diseases of unmet medical needs. PTX will expand the cohort at 45 mg/m² of PTX-200 together with cytarabine in patients with relapsed and refractory acute myeloid leukemia (AML).

Cohort expansion for its Phase 1b clinical study was planned after another complete remission was achieved and no dose-limiting toxicities were reported at this dose level.

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Three patients reported no dose-limiting toxicities following treatment with 45 mg/ m² PTX-200 plus cytarabine. One patient in the cohort reported complete disease remission, with neutrophils and/or platelets yet recovered to normal levels. Further, a patient from the prior cohort at 35mg/ m² reported a partial response (reduction in cancer burden).

AML, a bone marrow cancer preventing the formation of normal blood cells, affects 158,000 patients globally. It proliferates rapidly and has poor survival rates. Currently, it is an unmet medical need as most patients relapse after receiving initial chemotherapy.

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The Principal Investigator of the AML study is Professor Jeffrey Lancet. He is a world-renowned leukemia expert at H. Lee Moffitt Cancer Center (Moffitt) in Florida, US, where he is Chair of the Department of Malignant Hematology.

The latest data, along with data from the earlier Phase 1 monotherapy study of PTX-200 in AML patients, has guided Prescient and Professor Lancet to expand enrolment at this dose level to another three patients to further study safety and efficacy at this dose level.

Professor Lancet said, “It is encouraging to see a CRi at this dose level, which brings a total of four complete remissions on the study so far. It was also pleasing to see that this dose level was well tolerated by patients, with no reported dose-limiting toxicities.”

CR (complete remission) and CRi are typically ascribed the same predictive value of successful treatment outcome.

He further added that 45mg/m² is believed to be a biologically effective dose of PTX-200. Therefore, an additional three patients will be recruited at this dose level to continue to examine safety and effectiveness in this fragile patient population.

Stock information

At the time of writing this article (09 MAY 12:03 PM AEST), shares of PTX were trading at AU$0.127 with a gain of 2%.

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