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Highlights
Prescient Therapeutics (PTX) receives FDA clearance for a Phase 2 trial of PTX-100.
The trial focuses on relapsed and refractory cutaneous T-cell lymphomas (r/r CTCL).
Phase 1b data showed promising safety and response rates for PTX-100.
Prescient Therapeutics (ASX:PTX) has announced that the US Food and Drug Administration (FDA) has granted clearance for its Investigational New Drug (IND) application, allowing the commencement of a Phase 2 clinical trial for PTX-100. This development is a major milestone for the company, marking progress in the pursuit of innovative treatments for relapsed and refractory cutaneous T-cell lymphomas (r/r CTCL).
PTX-100, Prescient’s first-in-class Ras pathway inhibitor, builds on strong Phase 1b results. These findings demonstrated its potential to address unmet needs in T-cell lymphomas, with the drug already receiving Orphan Drug Designation from the FDA for all T-cell lymphomas.
Phase 2 Study Details
The upcoming Phase 2 study will be conducted across 15 global sites, including locations in Australia, the US, and Europe. The trial will focus on patients with advanced r/r CTCL who have undergone and failed at least two prior systemic therapies. Prescient’s trial will be led by Professor H. Miles Prince, AM, a globally recognized expert in T-cell lymphomas.
The study is structured into two parts:
- Phase 2a (Dose Optimization): Up to 40 patients will be randomized into two groups receiving either 500 or 1,000 mg/m² doses of PTX-100. A safety review committee will determine the optimal biologically effective dose for the next phase. Interim analysis may be undertaken.
- Phase 2b (Efficacy Evaluation): Approximately 75 patients will be enrolled to determine the treatment’s efficacy and safety.
Primary endpoints include objective response rate, while secondary endpoints include skin responses, progression-free survival, and overall quality of life metrics.
Building on Phase 1 Success
Phase 1b studies of PTX-100 enrolled 19 patients with T-cell lymphomas, showing promising outcomes. An overall response rate of 42% was observed, with five out of seven cutaneous T-cell lymphoma patients reporting clinical benefits. Responders achieved a median progression-free survival of over 12 months, significantly surpassing standard treatment outcomes.
Prescient Therapeutics has emphasized the transformative nature of this milestone, highlighting years of rigorous preclinical and clinical development. The company is optimistic about delivering a new therapeutic option to patients facing limited treatment alternatives.
As the Phase 2 trial progresses, Prescient aims to leverage its innovative approach to potentially redefine treatment standards for advanced T-cell lymphomas.
