Prescient Therapeutics opens first US site for PTX-100 trial

Prescient Therapeutics has crossed a major milestone in its international expansion, with the first US site now open for its Phase 2a clinical trial of PTX-100, a novel cancer therapy targeting relapsed or refractory cutaneous T-cell lymphoma.

The site initiation visit was completed at the VCU Massey Comprehensive Cancer Center in Richmond, Virginia, which is part of Virginia Commonwealth University and considered one of the top cancer research centres in the United States. This development marks the beginning of patient recruitment in the US for the trial.

PTX-100 is a first-in-class inhibitor targeting the GGT-1 enzyme, which plays a role in cancer cell survival. The compound disrupts key oncogenic pathways and has already demonstrated safety and signs of activity in earlier studies. It is the only drug of its kind currently in clinical development worldwide. PTX-100 has also received Orphan Drug Designation for all T-cell lymphomas and Fast Track Designation for the treatment of relapsed or refractory mycosis fungoides, the most common form of cutaneous T-cell lymphoma.

Prescient’s Chief Medical Officer Dr Marissa Lim welcomed the milestone, stating, “We are very pleased to have completed the first US site initiation at VCU Massey. This marks the start of US recruitment into the Phase 2a trial and allows American patients to access PTX-100 through this study.”

The global trial has already enrolled four patients across three Australian sites. Prescient expects to enrol up to 40 patients in this Phase 2a segment, with more US sites planned to open soon.

Scientific founder Professor Said Sebti, who has deep ties with VCU Massey, described the site launch as a personal and professional highlight. “There is no greater fulfilment than seeing a drug you co-invented begin to reach patients. The launch of this trial is both exhilarating and humbling.”

Chief Executive Officer James McDonnell added, “The completion of the first site in the US is another step forward in our Phase 2a trial. With sites now open on both sides of the Pacific, we are well positioned to accelerate recruitment and gather important data on PTX-100.”

The trial forms part of Prescient’s broader push into personalised cancer therapies, which also includes development of cell therapy enhancement technologies and its universal CAR-T platform, OmniCAR.

An online investor briefing with CEO James McDonnell is scheduled for Wednesday 16 July at 2pm AEST, offering shareholders and prospective investors a closer look at the company’s strategy and trial progress.

With the first US site now activated, Prescient is entering a new phase of clinical development. The coming months will reveal whether PTX-100 can deliver on its early promise and emerge as a viable treatment for patients with limited options.