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Prescient Therapeutics gains fast-track FDA designation for PTX-100 to treat T-cell lymphoma

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By Imelda Cotton - 
Prescient Therapeutics ASX PTX PTX-100 FDA Fast Track Designation
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Prescient Therapeutics (ASX: PTX) has received fast-track designation from the US Food and Drug Administration for lead candidate PTX-100 to treat adults with relapsed or refractory mycosis fungoides.

The skin condition – a type of blood cancer – is the most common subtype of cutaneous T-cell lymphoma (CTCL).

The FDA’s fast-track process aims to expedite the review of therapies that treat serious conditions with a high unmet need, with the aim of getting therapies to patients earlier, by improving regulatory access and approval pathways for drug manufacturers.

Potential treatment option

Prescient chief executive officer James McDonnell said fast-tracking of PTX-100 indicated its promise as a potential treatment option for mycosis fungoides alongside other therapies available in the US.

“Fast-track designation is a critical milestone towards our goal of advancing PTX-100 into a registration-enabling trial designed to support accelerated approval and commercialisation,” he said.

“As we progress our Phase 2 trials, we will be engaging closely with the FDA to ensure alignment on endpoints and study scope.”

Site initiation visit

Last month, Prescient completed the first site initiation visit for a Phase 2a clinical study of PTX-100 at the Epworth Freemasons haematology unit in Melbourne.

The open-label trial will evaluate two dosage levels in approximately 40 patients with relapsed/refractory CTCL.

Professor Miles Prince, a world-leading expert in the treatment of the disease, will be the principal investigator of the trial—the first of multiple Phase 2a studies Prescient will be initiating in Australia, the US and Europe.

Phase 1b results

A Phase 1b study of PTX-100, which enrolled 19 T-cell lymphoma (TCL) patients, demonstrated a good safety profile at various doses up to 2,000 milligrams per square metre.

Prescient reported a 42% overall response rate among all evaluable TCL patients, with six out of seven CTCL patients receiving clinical benefit.

Responders had a median progression-free survival (PFS) rate of over 10 months, surpassing the typical median PFS of approximately 3.1 months associated with vorinostat, the standard care treatment.

The Phase 1 study has since closed, with one patient still in complete response and continuing to receive PTX-100 under Australia’s compassionate access scheme.