The completion of Cohort 3 marks a significant milestone, with six participants receiving therapy with 67Cu-SAR-bisPSMA at the highest single dose level of 12GBq. Notably, no dose-limiting toxicities were reported in Cohort 3, showcasing a favorable safety profile across all cohorts.

An overall safety review of Cohorts 1, 2, and 3 demonstrated promising results, with most adverse events being mild or moderate. As a result, the Safety Review Committee has recommended advancing to Cohort 4, the multi-dose phase, at the highest dose investigated in the study.

Preliminary data from the trial revealed encouraging outcomes, with a majority of participants showing reductions in prostate-specific antigen (PSA) levels following treatment with 67Cu-SAR-bisPSMA. Notably, participants with the highest baseline PSA levels and extensive prior therapy demonstrated significant PSA reductions, underscoring the therapeutic potential of the treatment.

The SECuRE trial incorporates dosimetry assessments to evaluate the absorbed dose in organs and lesions by 67Cu-SAR-bisPSMA, further supporting the administration of multiple doses at the highest dose level.

Dr. Alan Taylor, Clarity's Executive Chairperson, expressed excitement about the trial's progress and the promising responses observed across all cohorts. He emphasized the importance of longevity of response and highlighted the potential for 67Cu-SAR-bisPSMA to become a gold standard therapeutic agent for mCRPC patients.

With recruitment open for Cohort 4 in the US, Clarity Pharmaceuticals aims to continue advancing its groundbreaking theranostic prostate cancer trial, offering hope for improved treatment outcomes in patients with advanced prostate cancer.