Prescient Therapeutics Ltd (ASX:PTX, OTC:PSTTF)has kicked off its Phase 2a clinical trial evaluating PTX-100 for relapsed or refractory Cutaneous T-Cell Lymphoma (CTCL), having dosed its first patient.
Important first step
Prescient Therapeutics chief medical officer Dr Marissa Lim said: “The first patient in Prescient’s Phase 2a study has been dosed at the Linear Clinical Research site in Perth, under the care of Dr. Dejan Radeski, a consultant haematologist with a special interest in T-cell lymphoma.
“This marks an important step in our mission to advance additional treatment options for CTCL”.
The open-label Phase 2a study will assess two dosage levels of PTX-100 across up to 40 patients at multiple sites in Australia, the United States and Europe.
The primary objective of the trial is to evaluate efficacy, with safety among the secondary endpoints.
CTCL is a rare subtype of non-Hodgkin lymphoma in which malignant T cells migrate to and proliferate in the skin, leading to chronic and often debilitating disease.
With limited treatment options available for patients with relapsed or refractory forms of the disease, PTX-100 represents a potential first-in-class therapy targeting an unmet clinical need.
PTX-100 is designed to inhibit geranylgeranyl transferase-1 (GGT-1), disrupting key oncogenic pathways that promote cancer cell survival.
Encouraging safety and clinical activity
Previous studies have demonstrated encouraging safety and clinical activity, prompting the United States Food and Drug Administration (FDA) to grant the compound both Orphan Drug Designation for all T-cell lymphomas and Fast Track Designation for relapsed or refractory mycosis fungoides, the most common form of CTCL.
The company is continuing patient recruitment as the study progresses.
Prescient will hold a live investor briefing on Thursday 29 May at 12pm (AEST) to provide further insights into the PTX-100 program and broader pipeline developments – see the company website for more information.