Prescient Therapeutics Ltd (ASX:PTX) has received authorisation from the European Clinical Trials Information System (CTIS) to initiate its PTX-100 clinical trial in patients with relapsed or refractory cutaneous T-cell lymphoma (r/r CTCL) in Italy.
The approval allows the Melbourne-based clinical-stage oncology company to activate trial sites and begin recruiting patients in Europe for the Phase 2a study of PTX-100, a first-in-class therapy targeting cancer growth pathways.
Prescient CEO James McDonnell said the CTIS decision was an important step for the program and for patients with this rare form of non-Hodgkin lymphoma.
“This authorisation marks a significant milestone for Prescient and for patients living with CTCL. It reflects months of dedicated work by our clinical team and brings us closer to delivering a new treatment option for a disease with high unmet need,” McDonnell said.
PTX-100 is being evaluated as a potential new treatment option for patients whose CTCL has returned or not responded to existing therapies, an area where treatment choices remain limited.
Orphan drug designation in Europe
Today's CTIS authorisation comes just weeks after Prescient secured orphan drug designation in Europe for PTX-100.
The company said the designation provides 10 years of data exclusivity following approval and enables direct engagement with the European Medicines Agency on study design. Prescient described the status as commercially advantageous and a key factor in improving its appeal to potential partners, while also addressing a significant unmet need for European patients, who currently have fewer treatment options than those in the United States.
CEO James McDonnell said the designation represents a meaningful step forward for the PTX-100 program and “provides choices” both clinically and commercially.
Prescient will host a live and online investor webinar on Tuesday, November 25 at 3:00 pm AEDT to discuss the implications of orphan drug status for PTX-100 and provide an update on its Phase II clinical development. Shareholders and interested investors have been directed to the company’s latest press release for registration details.