The first United States clinical trial site for Prescient Therapeutics Ltd (ASX:PTX, OTC:PSTTF)’s Phase 2a study of PTX-100 has been initiated. The site at Virginia Commonwealth University’s (VCU) Massey Comprehensive Cancer Center is one of the top cancer research centres in the US, and the initiation marks a major milestone in the company’s global clinical development strategy.
The US launch adds to four patients already enrolled across three Australian sites, advancing the trial’s goal of recruiting up to 40 patients globally.
Prescient CEO James McDonnell confirmed that more trial sites are expected to open in the coming weeks and will explain more during an investor briefing on Wednesday, July 16, at 2:00pm AEST.
Register here: https://prescienttherapeutics.investorportal.com.au/investor-briefing/
VCU Massey Cancer Center joins Phase 2a trial
Chief medical officer Dr Marissa Lim said the site will now begin enrolling American patients for the global trial, giving them access to PTX-100.
“We are very pleased to have completed the first US site initiation visit at the VCU Massey Comprehensive Cancer Center in Richmond, Virginia. This is part of the Virginia Commonwealth University (VCU) which is ranked as one of the top cancer research centres in the US. This site initiation marks the start of the US recruitment into the Phase 2a trial, allowing US patients to access PTX-100 through this trial," Lim said.
Scientific founder Professor Said Sebti, based at VCU, called the milestone “exhilarating and humbling”, adding that it brings a long-term vision closer to clinical impact.
“As a cancer researcher, there is no greater fulfillment than seeing a drug you co-invented in the laboratory begin to touch patients’ lives; so the launch of this global Phase 2 clinical trial of PTX-100 in r/r CTCL is one of the most exhilarating and humbling moments of my career, and a powerful reminder of what science can achieve when driven by purpose and passion. I’m profoundly proud that VCU Massey Comprehensive Cancer Center, my academic home, is the first US site to open for patient accrual, bringing us one step closer to turning a long-held dream into meaningful impact for patients,” Sebti said.
Background on PTX-100: A first-in-class GGT-1 inhibitor
PTX-100 targets geranylgeranyl transferase-1 (GGT-1), an enzyme involved in cancer growth. The compound blocks Ras-dependent pathways, leading to cancer cell death. It is currently the only GGT-1 inhibitor in clinical development worldwide.
PTX-100 has shown encouraging efficacy and safety in prior Phase 1b studies in T-cell lymphomas, and has received Orphan Drug Designation and Fast Track Designation from the United States Food and Drug Administration (FDA) for T-cell lymphoma and relapsed/refractory mycosis fungoides, respectively.
The Phase 2a trial aims to recruit up to 40 global patients, with ongoing site expansion in both the US and Australia. The trial builds on prior data suggesting strong safety and early clinical activity. Prescient Therapeutics continues to engage with key stakeholders and expand trial access to additional eligible patients. The company anticipates that further site initiations will accelerate enrolment and data readout timelines.
About Prescient Therapeutics
Prescient Therapeutics is a clinical-stage oncology company developing personalised therapies, including small molecule and cell therapy platforms. Its pipeline includes:
- PTX-100 (targeted therapy for T-cell lymphomas)
- CellPryme-M (enhancing cell therapy potency during manufacturing)
- CellPryme-A (boosting in vivo cell therapy effectiveness)
- OmniCAR (a modular, controllable CAR-T cell platform for multiple tumour targets)