Clarity Pharmaceuticals Begins Cohort Expansion Phase in Secure Trial for Prostate Cancer

Clarity Pharmaceuticals (ASX: CU6) has commenced dosing the first participant in the Cohort Expansion Phase (Phase II) of its SECuRE trial with 8 GBq of 67Cu-SAR-bisPSMA. This follows the successful completion of the Dose Escalation Phase and a recommendation from the Safety Review Committee to advance the study based on strong safety and efficacy results. The expanded protocol allows up to six treatment cycles. It includes a subset of patients receiving combination therapy with enzalutamide (ARPI), supported by insights from the Enza-p trial and global clinical experts. The trial now focuses on pre-chemotherapy metastatic castration-resistant prostate cancer (mCRPC) patients, where earlier data showed PSA reductions of ≥35% in 92% of participants and ≥80% in 46.2%. Clarity has also introduced an enhanced room-temperature stable formulation of 67Cu-SAR-bisPSMA to support late-stage trials and future commercial production. Backed by FDA Fast Track Designations, Clarity aims to accelerate development and improve treatment outcomes for prostate cancer patients.

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