Prescient Therapeutics Ltd (ASX:PTX) earlier this week received European authorisation to begin clinical trials for PTX-100 in Italy, marking a major step in the company’s Phase 2A development program.
The company said the approval enables it to activate clinical sites in Italy and, later, in France. These sites will support ongoing patient recruitment for the Phase 2A trial, which has already commenced in Australia and the United States.
CEO James McDonnell told investors that the trial will involve up to 20 patients and include two dosing arms. He noted that the study builds on positive data from a Phase 1B trial in chronic lymphocytic leukaemia (CLL) patients, specifically in sub-analyses that demonstrated favourable responses.
Prescient said the first European clinical site will be in Bologna, with additional French sites to follow once administrative procedures are completed early next year. “It allows us to start activating sites in Italy and in the future France,” McDonnell said.
A dose optimisation committee is expected to review initial patient data in mid to late 2026, which will help determine the trial’s next steps.
The company emphasised that the Phase 2A program remains a key clinical focus, as PTX-100 progresses toward broader validation across multiple jurisdictions.
The company is advancing site activations and patient enrolment in parallel, with the aim of generating sufficient safety and efficacy data to support future development decisions.
PTX-100 is an investigational compound being evaluated for its potential in treating haematological cancers. The company previously reported encouraging results from Phase 1B, and the Phase 2A study aims to replicate and build on those outcomes.
Prescient continues to pursue a multi-regional approach to clinical development, leveraging regulatory progress in Europe alongside existing operations in the US and Australia.
Proactive: Welcome back to Proactive Newsroom. I'm now joined by Prescient Therapeutics CEO James McDonnell. James, good to see you again.
James McDonnell: Good to see you. Good to be here.
Proactive: James, it's quite a milestone today for the company. You've now been granted European authorisation to begin clinical trials in Italy for PTX-100. What exactly does this green light from Europe grant you?
James McDonnell: This is important for the Phase 2A study. It allows us to start activating sites in Italy and in the future France. That’s important as we recruit patients into the study.
Proactive: This is all in the lead-up to a Phase 2A trial, like you just mentioned. What is the current timeframe for that?
James McDonnell: We're progressing it. We've had patients here in Australia and we have them in the US and in Europe. We expect 20 patients to be enrolled. The dose optimisation committee will review the data. We're expecting that sometime mid to late next year. Then we'll be able to make decisions on the next part forward.
Proactive: Phase 2 has already started in Australia and the US. It’s on the way to Europe now, kicking off in Italy. Let’s give investors a bit of a refresher — what will Phase 2A entail?
James McDonnell: Phase 2A will entail up to 20 patients and two dosing arms. We've got some very good data from our Phase 1B study in CLL patients, particularly in our sub-analysis. We're hoping to move that forward and get similar type results as we progress through Phase 2A.
Proactive: You've now been given the green light to go ahead and dose the first patient in Italy. That will follow in the next few weeks. How will the rest of Europe follow now that this announcement is out?
James McDonnell: We'll be opening sites that will then be able to recruit patients. The first site is in Bologna. France is the other country we have scheduled, and they will follow suit in the new year once we complete some extra paperwork.
Proactive: Prescient Therapeutics CEO James McDonnell, always good to have you on. Thank you so much for those updates.