Prescient Therapeutics CEO James McDonnell talked with Proactive about the company’s latest milestone — receiving European authorisation to begin its Phase 2A clinical trial of PTX-100 in Italy.
McDonnell explained that this approval enables site activations across Italy and, in due course, France. "It allows us to start activating sites in Italy and in the future of France. And so that's important as we recruit patients into the study," he said.
The Phase 2A study focuses on dose optimisation, building on promising data from the previous Phase 1B trial in CLL patients. According to McDonnell, up to 20 patients will be enrolled across two dosing arms. Recruitment has already started in Australia and the US, with Europe now coming online.
Prescient expects data from the trial to be reviewed by a dose optimisation committee around mid to late next year. Based on that, the company will determine the next stage of development.
Site activation has already begun in Bologna, Italy. France is expected to follow in the new year after some additional paperwork is finalised.
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