Prescient Therapeutics Doses First Patient in Phase 2a PTX-100 Trial for Rare T-Cell Lymphoma

Key Highlights:

• First patient dosed in PTX-100 Phase 2a study targeting relapsed/refractory Cutaneous T-Cell Lymphoma (CTCL).
• Study to recruit up to 40 patients across Australia, the USA, and Europe.
• PTX-100 is the world’s only GGT-1 inhibitor in clinical development.
   

Prescient Therapeutics Ltd (ASX: PTX) marked a key milestone today, announcing the dosing of the first patient in its Phase 2a clinical trial for PTX-100—a promising investigational therapy for relapsed/refractory Cutaneous T-Cell Lymphoma (CTCL). This rare form of cancer affects T-cells, integral to the immune system, which instead attack the skin, leading to debilitating and often treatment-resistant disease.

The Phase 2a trial, an open-label study, aims to enrol up to 40 patients across clinical sites in Australia, the USA, and Europe. The primary focus will be on evaluating PTX-100’s efficacy, with safety as a secondary endpoint. The first patient was dosed at the Linear Clinical Research site in Perth under the supervision of Dr. Dejan Radeski, a consultant haematologist with a special interest in T-cell lymphomas.

PTX-100, Prescient’s lead targeted therapy, is a first-in-class inhibitor of geranylgeranyl transferase-1 (GGT-1)—a critical enzyme in cancer growth pathways. By disrupting the oncogenic Ras pathway, PTX-100 induces cancer cell death while sparing healthy cells. Previous Phase 1 studies demonstrated a strong safety profile and encouraging early efficacy signals, supporting the move into this Phase 2a study. Notably, the U.S. FDA has granted PTX-100 Orphan Drug Designation for all T-cell lymphomas and Fast Track Designation for adults with relapsed or refractory mycosis fungoides, the most common subtype of CTCL.

CEO James McDonnell hailed the milestone as a testament to Prescient’s commitment to addressing urgent unmet needs in oncology. “Dosing the first patient in our Phase 2a study is a critical step in delivering new hope for CTCL patients who have limited options,” McDonnell said.

Investors and stakeholders can learn more at a scheduled investor briefing on May 29, with McDonnell set to discuss the company’s broader oncology pipeline, including its innovative CellPryme and OmniCAR platforms.

Prescient’s share price (ASX: PTX) ticked up 4.35% to $0.048 today, on modest volume of around 846,000 shares. The company’s market cap stands at $38.7 million, reflecting the early-stage nature of its clinical programs.

Looking ahead, the successful advancement of PTX-100 could not only provide a lifeline for patients battling CTCL but also reinforce Prescient’s position as a leader in next-generation targeted and cellular therapies. As the study progresses, eyes will be on enrolment milestones, safety updates, and early efficacy signals—each critical in determining the commercial and clinical potential of PTX-100.