Clarity Pharmaceuticals advances in SECuRE trial with promising prostate cancer treatment results

Clarity Pharmaceuticals (ASX: CU6), a clinical stage radiopharmaceutical company, announced significant progress in the SECuRE trial, marking a pivotal step in cancer treatment research. The company, dedicated to developing next-generation products for better cancer treatment outcomes, has successfully completed the first stage of cohort 3 in this Phase I/IIa trial.

Promising Results in Advanced Prostate Cancer Treatment

The SECuRE trial, focusing on metastatic castrate-resistant prostate cancer (mCRPC), has achieved encouraging outcomes. Three participants received the highest dose level of 12GBq of 67Cu-SAR-bisPSMA without any severe adverse events. This result is particularly noteworthy considering the advanced stage of the trial and the condition of the participants, who had previously undergone various treatments.

Safety and Efficacy at the Forefront

Clarity’s approach emphasizes the safety and efficacy of its treatment. The sole adverse event reported was a Grade 1 reduction in neutrophil count in one participant, who has since fully recovered. The Safety Review Committee (SRC) has endorsed the continuation of the trial with three additional participants, affirming the trial’s safety profile.

Clarity Pharmaceuticals Achieves Milestone in Prostate Cancer Theranostic Trial

Innovative Approach in Radiopharmaceutical Treatment

Dr. Alan Taylor, Executive Chairperson of Clarity, commented on the trial’s progress. “The favorable safety profile and absence of dose-limiting toxicities are significant. Moreover, the dual targeting mechanism of SAR-bisPSMA sets it apart from other PSMA products, showcasing higher uptake and retention in lesions,” he said.

Next Steps in the SECuRE Trial

The SECuRE trial is a multi-center, single-arm, dose escalation trial with a cohort expansion, involving up to 44 patients across the US. Its aim is to assess the safety and effectiveness of 67Cu-SAR-bisPSMA in treating prostate cancer. The trial’s next phase will evaluate multiple doses of 67Cu-SAR-bisPSMA, following the successful evaluation of single doses.

Encouraging Outcomes for Pre-Treated Patients

Notably, two of the three participants in cohort 3 demonstrated a significant reduction in Prostate Specific Antigen (PSA) levels within weeks of dosing, with one showing over a 90% reduction. This outcome is particularly encouraging, as all participants were heavily pre-treated and had failed multiple other therapies.

With these advancements, Clarity Pharmaceuticals continues to be at the forefront of developing innovative and effective cancer treatments, potentially transforming the landscape of prostate cancer therapy.