Clinical-stage oncology company Prescient Therapeutics (ASX:PTX) has announced the results of its Phase 1b study of PTX-100 in patients with advanced malignancies.
The study's focus was on patients with relapsed and refractory T-cell lymphomas (r/r TCL).
Prescient said the study successfully achieved its primary objectives of demonstrating safety and determining pharmacokinetics (PK) and pharmacodynamics (PD). It said it also successfully demonstrated preliminary efficacy in r/r TCL patients exceeding that expected from the standard of care.
The company said it is currently working towards a Phase 2 trial in r/r TCL, due to start around mid-2024.
According to the study's principal investigator, haematologist Professor H. Miles Prince AM, "These Phase 1b results highlight the excellent tolerability of PTX 100 among TCL patients. Beyond monotherapy, PTX's excellent safety profile make it a viable option for exploring combination therapies in the future.
"In addition to PTX-100's safety, early indications suggest promising efficacy in both systemic and cutaneous T cell lymphomas, as evidenced by several patients exhibiting clinical responses and others demonstrating durable stable disease. Notably, the median PFS of 12.2 months surpasses the usual expectations associated with standard care treatments, which typically yield a median PFS of around 4 months.
"This compelling outcome fuels my enthusiasm to advance into a Phase 2 study. I am hopeful that expanding this research will provide a beacon of hope for patients facing limited treatment options and poor anticipated outcomes."
Prescient CEO and managing director Steven Yatomi-Clarke added, "Prescient is very pleased with the data from this Phase 1b study in patients with relapsed and refractory TCL. The data has surpassed our expectations, from both safety and early efficacy perspectives, especially in this difficult to treat patient population. The team is working judiciously with its advisors in planning and working towards the Phase 2 study, which Prescient believes will be a watershed moment for the company."
