Prescient Therapeutics Opens First US Site for PTX-100 CTCL Trial – What’s Next?
Prescient Therapeutics has initiated its first US clinical site for the PTX-100 Phase 2a trial targeting Cutaneous T-Cell Lymphoma, marking a key milestone in expanding patient recruitment beyond Australia.
- First US clinical site opened at VCU Massey Comprehensive Cancer Center
- Adds to ongoing recruitment of 4 patients across 3 Australian sites
- PTX-100 targets relapsed/refractory Cutaneous T-Cell Lymphoma (CTCL)
- FDA granted orphan drug and fast track designations for PTX-100
- CEO James McDonnell to host investor briefing on July 16
Expanding Clinical Reach
Prescient Therapeutics Limited (ASX, PTX) has announced the initiation of its first US clinical site for the Phase 2a trial of PTX-100, a targeted therapy for relapsed or refractory Cutaneous T-Cell Lymphoma (CTCL). The new site at the VCU Massey Comprehensive Cancer Center in Richmond, Virginia, a leading cancer research institution, represents a significant step in broadening the trial’s geographic footprint and patient access.
Until now, patient recruitment has been focused on three Australian sites, with four patients enrolled. The addition of the US site is expected to accelerate enrollment and provide access to a wider patient population, potentially enhancing the robustness of clinical data.
PTX-100, A Targeted Oncology Candidate
PTX-100 is a first-in-class inhibitor targeting geranylgeranyl transferase-1 (GGT-1), an enzyme involved in oncogenic pathways that promote cancer cell survival. By disrupting these pathways, PTX-100 aims to induce apoptosis in cancer cells. The drug has already demonstrated safety and encouraging activity in earlier Phase 1 and 1b studies across hematological and solid tumors.
The US Food and Drug Administration (FDA) has granted PTX-100 orphan drug designation and fast track status for CTCL, underscoring the unmet medical need and the potential for expedited development. These regulatory designations may facilitate a smoother path toward approval if clinical outcomes prove favorable.
Leadership Perspective and Next Steps
Prescient’s CEO, James McDonnell, highlighted the milestone as a pivotal moment in the company’s clinical development journey. He emphasized the importance of expanding patient access and advancing the trial toward completion. An investor briefing is scheduled for July 16, where McDonnell will provide further insights into trial progress and company strategy.
Scientific founder Professor Said Sebti expressed pride in the collaboration with VCU Massey Comprehensive Cancer Center, noting the significance of translating laboratory discoveries into potential patient benefits. The company anticipates enrolling up to 40 patients globally in this Phase 2a trial segment.
Broader Oncology Pipeline
Beyond PTX-100, Prescient is developing complementary cell therapy platforms, including CellPryme-M and CellPryme-A, designed to enhance the efficacy and persistence of adoptive T-cell therapies. Additionally, the OmniCAR platform offers a modular, universal immune receptor system aimed at improving CAR-T cell targeting and control.
These pipeline assets position Prescient as a diversified player in the oncology biotech space, with multiple avenues to address cancer treatment challenges.
Bottom Line?
With US patient recruitment underway, Prescient’s PTX-100 trial is poised for critical data readouts that could reshape CTCL treatment options.
Questions in the middle?
- How quickly will patient enrollment ramp up at the new US site?
- What interim efficacy signals might emerge from the Phase 2a trial?
- How will Prescient’s broader cell therapy platforms integrate with PTX-100’s development?
