Clarity reports on third cohort in copper theranostic trial

Clarity Pharmaceuticals has completed its third cohort in the theranostic SECuRE trial evaluating copper-64 (Cu-64) and copper-67 (Cu-67) sarcophagine chelator technology in patients with metastatic castration-resistant prostate cancer.

In this phase I/IIa trial of Cu-64 for the diagnostic and Cu-67 for the therapeutic, the company noted no dose-limiting toxicities in cohort 3, and an overall safety review of all cohorts 1, 2, and 3 also showed favorable safety profiles. Cohort 3 participants had the highest number of pretreatments prior to entering the study across all cohorts, with most patients receiving five or more lines of therapy.

"Although the last participants in cohort 3 only completed dosing in January 2024, 60% of participants across all cohorts so far showed reductions in prostate-specific antigen (PSA) levels of greater than 35% from a single dose of Cu-67 SAR-bisPSMA. Twenty-seven percent of participants showed reductions in PSA levels of greater than 80%," the company said.

This and other published data await review by the U.S. Food and Drug Administration (FDA), according to the firm, and the drugs are not yet commercially available.

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