Prescient Therapeutics has reached an enrolment milestone in its Phase 2a trial of PTX-100 for patients with relapsed or refractory cutaneous T-cell lymphoma, setting the company up for a planned dose optimisation review in December.
The Melbourne-based clinical-stage oncology company said 20 patients are now evaluable in the study, with 10 patients having completed four cycles of treatment in each of the trial’s two dosing arms.
That meets the pre-specified threshold for the first meeting of the study’s Dose Optimisation Committee, an independent group of clinical and biostatistical experts that will assess safety and efficacy data from both arms before advising on the next stage of development.
Prescient said the committee remains on track to meet in December 2026, after which the company expects to update the market on its recommendation.
The milestone does not mark the end of the study. Recruitment is continuing internationally, with the Phase 2a component designed to enrol up to 40 evaluable patients.
PTX-100 is being investigated as a treatment for cutaneous T-cell lymphoma, a rare form of non-Hodgkin lymphoma that affects the skin. The study is focused on patients whose disease has relapsed or failed to respond to previous therapies.
The drug is intended to inhibit geranylgeranyl transferase-1, an enzyme involved in cancer-related signalling pathways. Prescient says the mechanism disrupts pathways involving Rho, Rac and Ral proteins, which are associated with cancer cell growth and survival.
PTX-100 has already received US Food and Drug Administration Orphan Drug Designation for all T-cell lymphomas. It also has Fast Track Designation for adults with relapsed or refractory mycosis fungoides, the most common subtype of cutaneous T-cell lymphoma.
Chief executive James McDonnell said reaching the enrolment threshold reflected the work of the company’s clinical team and participating study sites.
He said Prescient was now looking ahead to the committee’s December assessment as it seeks to move PTX-100 into its next phase of development.
The company is also developing cell therapy technology platforms, including OmniCAR, CellPryme-A and CellPryme-M, although those programs remain at earlier stages of development.
