Highlights
Prescient Therapeutics launches first US site at VCU Massey for Phase 2a PTX-100 trial
The global study now includes patients across both US and Australia
PTX-100, a GGT-1 inhibitor, is the only compound of its class currently in clinical development
Prescient Therapeutics Ltd (ASX:PTX), a biotechnology company listed on the ASX 300, has commenced patient enrolment in the United States for its Phase 2a clinical trial of PTX-100. The study targets relapsed and refractory cutaneous T-cell lymphoma (CTCL) and marks a significant step in the company’s international development strategy.
The first US site has been activated at the Virginia Commonwealth University’s Massey Comprehensive Cancer Center, a leading institution in cancer research. This site will now begin recruiting American participants, complementing patient enrolment already underway at Australian trial locations.
VCU Massey Begins US Participation in CTCL Trial
Prescient’s initiation of the US arm of its PTX-100 trial follows four enrolled patients across three Australian sites. The VCU Massey Comprehensive Cancer Center in Richmond, Virginia, is the first of several expected US sites to join the global study.
Dr Marissa Lim, Prescient’s chief medical officer, confirmed the site activation and commencement of enrolment. VCU Massey is part of a leading cancer research university and is now positioned to contribute significantly to the data pool through US patient participation.
Scientific Legacy Drives Clinical Progress at VCU
Professor Said Sebti, scientific founder of PTX-100 and a researcher based at VCU, described the US launch as a profound milestone. According to Sebti, advancing a drug from lab development to patient treatment represents a deeply meaningful moment for cancer researchers. He also noted the personal significance of the site initiation occurring at his academic home institution.
The trial’s expansion into the US is designed to support broader enrolment and accelerate data collection, with further site activations expected in the coming weeks.
PTX-100 Targets Novel Pathway in T-cell Lymphoma
PTX-100 is a first-in-class inhibitor of geranylgeranyl transferase-1 (GGT-1), an enzyme involved in cancer cell survival. By disrupting Ras-dependent signalling, the therapy promotes cancer cell death. PTX-100 is currently the only GGT-1 inhibitor undergoing clinical trials globally.
Prescient’s ongoing development program is supported by earlier Phase 1b trial data showing a favourable safety profile and clinical signals in T-cell lymphoma cases. The therapy has received Orphan Drug Designation and Fast Track Designation from the US Food and Drug Administration for use in T-cell lymphoma and relapsed/refractory mycosis fungoides.
Prescient’s Broader Oncology Pipeline in Focus
Prescient Therapeutics is a clinical-stage oncology company advancing targeted and cell therapy platforms. In addition to PTX-100, its pipeline includes CellPryme-M for enhancing manufacturing-stage cell therapy efficacy, CellPryme-A for boosting in vivo effectiveness, and the OmniCAR platform, which allows modular control of CAR-T therapies.
With continued site expansion and enrolment under way, Prescient is moving forward with its trial timelines while engaging international partners and clinical stakeholders.