Just the Facts: Prescient Therapeutics secures FDA approval for PTX-100 Phase 2 trials

Proactive - Interviews for investors

Proactive’s Tylah Tully breaks down ‘Just the Facts’ of the latest news from Prescient Therapeutics Ltd (ASX:PTX, OTC:PSTTF). The company has received US FDA clearance to proceed with Phase 2 clinical trials for its Ras pathway inhibitor, PTX-100. This study will focus on relapsed and refractory cutaneous T-cell lymphomas (r/r CTCL). The decision follows the completion of a Phase 1b trial involving 19 T-cell lymphoma patients, which demonstrated an excellent safety profile and a 42% overall response rate. Among evaluable r/r CTCL patients, five of seven experienced clinical benefits. The global Phase 2 trial will enrol 115 patients across 15 sites in Australia, the US and Europe. It will consist of two parts: dose optimisation and efficacy assessments. Primary endpoints include objective response rate, with secondary metrics focusing on progression-free survival, overall survival, safety, and quality of life. The company describes FDA clearance as a transformative milestone, reflecting years of preclinical and clinical development. Prescient aims to collaborate with global CTCL experts to deliver a safe and effective therapy for this area of unmet need. The announcement drove a 55% surge in the company’s shares. #ProactiveInvestors #PrescientTherapeutics #ASX #OTC #PTX100 #FDAApproval #ClinicalTrials #OncologyResearch #TCellLymphoma #CTCL #CancerTreatment #OrphanDrug #Phase2Trial #GlobalTrial #DrugDevelopment #MedicalInnovation #PatientCare #RasPathway #CutaneousLymphoma #BiotechNews #ClinicalResearch #ASXStocks #PharmaInnovation