Prescient Therapeutics’ Progresses to Next Dose Level in PTX-200 AML Phase 1b Study

Summary

• Prescient Therapeutics’ Phase 1b trial with PTX-200 in AML progresses to the next dose level of 35 mg/m² PTX-200.
• Phase 1b study of PTX-200 at a dose of 25 mg/m² demonstrated no dose-limiting toxicities and therapy was better tolerated.
• The first cohort of three patients with this amended protocol (35 mg/m² PTX-200) was enrolled and completed without any dose-limiting toxicities.

Prescient Therapeutics Limited (ASX:PTX) is an ASX-listed biotechnology company engaged in developing targeted and personalised medicines for treating challenging cancers with unmet medical needs.

Two drug candidates PTX-200 and PTX-100 are the targeted therapies of Prescient. PTX-200 is a novel PH domain inhibitor under clinical study for relapsed & refractory AML, HER2-negative breast cancer, and recurrent or persistent platinum-resistant ovarian cancer.

On 3 August 2020, Prescient disclosed that its Phase 1b study of PTX-200 & cytarabine in AML (Acute Myeloid Leukemia) patients completed the first cohort at 25 mg/m2 PTX-200 under the modified study protocol.

Prescient increased the next dose level to 35 mg/m² PTX-200

Prescient disclosed that no dose-limiting toxicities were observed with the first cohort, and therapy was better tolerated. Now PTX is progressing the dose to the next level of 35 mg/m2 PTX-200.

As reported earlier, three of 15 patients in a notoriously difficult to treat cancer population (relapsed or refractory AML patients), experienced complete responses.

Prescient disclosed that the modification in the study was made in consultation with the study investigators to change the dosing schedule of PTX-200 concerning the administration of chemotherapy agent cytarabine, and the aim of modification is to minimise the potential for overlapping drug interactions that possibly could lead to side effects.

This modification entailed maintaining the day 1 PTX-200 dose and removal of days 8 and 15 while impeding the beginning of the cytarabine 5-day continuous infusion to days 3 to 7 (of a 21-day cycle).

Pleasingly, Prescient stated that the first cohort of 3-patients with this amended protocol was enrolled and completed without any dose-limiting toxicities reported.

Upon evaluation of the safety data from this modified cohort with the investigators of the study, the Company has opened the next cohort for enrolment at 35 mg/m² PTX-200, and this cohort is actively screening.

Management Commentary

Prescient’s Chief Medical Officer, Dr Terrence Chew stated-

ALSO READ: Another Golden Feather in Prescient’s Hat, PTX-200 Receives Two US Patents

On 3 August 2020, PTX traded at A$0.058 climbed by 3.571% at AEST 1:10 PM. The market cap of PTX stood at A$22.08 million.

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