Clarity Pharmaceuticals (ASX:CU6) Advances Cancer Therapy with Phase II Trial Milestone

Highlights 

• Clarity Pharmaceuticals begins Phase II cohort expansion in SECuRE trial 
• First patient treated with 8 GBq dose of improved radiopharmaceutical 
• New formulation enhances stability and scalability for future trials 

Clarity Pharmaceuticals (ASX:CU6), a clinical-stage radiopharmaceutical company, has marked a significant development in its SECuRE trial by treating the first patient in the Cohort Expansion Phase II of the study. This phase involves 24 participants and utilizes an 8 GBq dose of the therapeutic candidate 67Cu-SAR-bisPSMA, following a green light from the Safety Review Committee to increase both the dosage and number of treatment cycles. 

The SECuRE trial is focused on evaluating the efficacy and safety of 67Cu-SAR-bisPSMA, a copper-based radiopharmaceutical therapy designed for patients with metastatic castration-resistant prostate cancer (mCRPC). This next phase aims to build on the early success seen in the dose escalation stage of the study and provide deeper insights into treatment response and patient outcomes. 

One of the key developments accompanying this phase is the introduction of a new and enhanced formulation of 67Cu-SAR-bisPSMA. The reformulated version offers improved room temperature stability and better scalability, both crucial factors for late-stage clinical trials and potential future commercial manufacturing. These advancements not only support the current trial but also position the therapy for more seamless integration into wider clinical practice should the data remain favorable. 

Dr Alan Taylor, Executive Chairperson of Clarity Pharmaceuticals, expressed optimism about the SECuRE trial’s trajectory, emphasizing the strategic updates to the protocol and the company’s commitment to scientific rigor. “The latest protocol amendments ensure that we are utilizing the most recent advances and knowledge in the radiopharmaceutical space,” he noted. “We continue to be driven by the highest standards of clinical trial management and research.” 

The SECuRE trial represents a cornerstone in Clarity Pharmaceuticals’ broader clinical pipeline and aligns with the growing momentum in targeted radiopharmaceutical therapies. By using copper-67, the company leverages a next-generation isotope that offers both diagnostic and therapeutic benefits, strengthening the potential for a theranostic approach in treating prostate cancer. 

With the cohort expansion now underway, Clarity Pharmaceuticals continues to progress toward its goal of offering innovative, targeted cancer treatments built on a robust platform of radiopharmaceutical science.