Clinical-stage oncology company Prescient Therapeutics Ltd has opened the first clinical site for its Phase 2a study of PTX-100 in patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL).
Prescient Therapeutics chief medical officer, Dr Marissa Lim said: “It is very exciting to reach this milestone of opening the first study site for the Phase 2a study of PTX-100 at the Epworth Freemasons Haematology Clinical Trial Unit.
“Professor Miles Prince, AM, a world leading expert in the treatment of patients with CTCL will be the principal investigator.
“We look forward to working with Professor Prince and his international medical colleagues around the globe as we advance the development of our first-in-class therapeutic candidate.”
First of several sites
This follows a successful Site Initiation Visit (SIV) at the Epworth Freemasons Haematology Clinical Trial Unit in Melbourne.
The site is the first of several that Prescient plans to activate across Australia, the United States and Europe in the coming months.
The Phase 2a study is designed as an open-label trial to evaluate two dosage levels of PTX-100 in some 40 patients diagnosed with CTCL, a rare and difficult-to-treat non-Hodgkin lymphoma that primarily affects the skin.
Efficacy and safety
The primary endpoint of the trial is efficacy, with secondary endpoints including safety and other relevant clinical markers.
PTX-100 is a first-in-class inhibitor of geranylgeranyl transferase-1 (GGT-1), an enzyme involved in activating cancer-promoting proteins within the Ras pathway.
By disrupting this pathway, PTX-100 induces apoptosis in malignant cells.
It is currently believed to be the only GGT-1 inhibitor undergoing clinical development globally.
The investigational therapy has previously demonstrated a favourable safety profile and early signs of efficacy in earlier-stage clinical trials, including a recently completed Phase 1b expansion cohort in T-cell lymphomas.
These findings have provided the foundation for the current Phase 2a program. PTX-100 has also received Orphan Drug Designation from the United States Food and Drug Administration (FDA) for the treatment of all T-cell lymphomas, offering regulatory incentives including potential market exclusivity.
The current trial is expected to provide important data to inform future development, with patient enrolment and first dosing anticipated to commence shortly.
Targeted therapy pipeline
PTX-100 is part of Prescient’s targeted therapy pipeline, which sits alongside its cell therapy platforms – CellPryme-M, CellPryme-A and OmniCAR – supporting the company’s mission to develop advanced, personalised treatment options for cancer patients.
The CellPryme and OmniCAR platforms are being developed to enhance cell therapy efficacy, durability, and flexibility and remain in pre-clinical stages.
The company is hosting a live investor briefing on Monday 31 March at 12pm AEDT to provide further insights into the PTX-100 program and its broader development pipeline. Investors can register for the session at: https://prescienttherapeutics.investorportal.com.au/investor-briefing.
Further updates on site activations and study progress are expected in the coming weeks.