PTX-100 CTCL Phase 2a study reaches review milestone
Prescient Therapeutics Ltd
Key points
- Reached pre-specified enrolment threshold for first planned DOC review
- 20 evaluable patients enrolled in Phase 2a study
- DOC review on track for December 2026
Full summary
Prescient Therapeutics Limited (ASX: PTX) has achieved a significant milestone in its Phase 2a study of PTX-100 for relapsed/refractory cutaneous T-cell lymphoma (CTCL). The study has enrolled 10 evaluable patients in each of the two dosing arms, reaching the pre-specified enrolment threshold for the first planned Dose Optimisation Committee (DOC) review. The DOC, comprising clinical and biostatistical experts, will convene in December 2026 to review safety and efficacy data from both dosing arms and provide guidance on the study's continuation. This milestone aligns with the company's clinical development timeline. PTX-100 has been granted Orphan Drug Designation by the US FDA for all T-cell lymphomas and Fast Track Designation for the treatment of adults with relapsed or refractory mycosis fungoides, the most common subtype of CTCL.
Outlook
The DOC review in December 2026 will provide guidance on the continuation of the study for further development.