Clarity Pharmaceuticals (ASX: CU6), a clinical-stage radiopharmaceutical company committed to advancing next-generation products that enhance treatment outcomes for both pediatric and adult cancer patients, is excited to announce a significant milestone in its mission. The first participant in the highest dose cohort, receiving a dose of 12GBq, has been successfully dosed in the Phase I/II theranostic trial evaluating 67Cu SAR-bisPSMA for metastatic, castrate-resistant prostate cancer (mCRPC).

The ongoing SECuRE trial (NCT04868604)[1] is a groundbreaking Phase I/IIa theranostic initiative designed for the identification and treatment of individuals with metastatic, castrate-resistant prostate cancer expressing Prostate-Specific Membrane Antigen (PSMA) using 64Cu/67Cu SAR-bisPSMA. The trial aims to visualize PSMA-expressing lesions through 64Cu SAR-bisPSMA, aiding in the selection of suitable candidates for subsequent 67Cu SAR-bisPSMA therapy. Encompassing a multi-center, single-arm, dose-escalation approach, the trial involves up to 44 participants across the United States. The primary objective is to ascertain the safety and efficacy of 67Cu SAR-bisPSMA as a potential treatment for prostate cancer.

Notably, Cohort 3 represents a pivotal phase investigating the impact of the highest dosage of 12GBq in SECuRE trial participants, following a single administration of 67Cu SAR-bisPSMA. This cohort marks the conclusion of the assessment of single doses of 67Cu SAR-bisPSMA and paves the way for a multi-dose cohort, pending thorough safety evaluation.

Promisingly, the initial two cohorts in the dose escalation phase of the trial were successfully concluded, with no dose-limiting toxicities reported. Among these, the three participants in Cohort 2, who received a single dose of 8GBq of 67Cu SAR-bisPSMA, have exhibited encouraging outcomes. Monitored closely by their medical teams, all three participants have displayed a remarkable reduction of over 50% in PSA levels—a primary endpoint of the SECuRE trial, often used as a surrogate marker of efficacy in this patient population. Notably, PSA levels have continued to decrease, with the first two participants showcasing reductions exceeding 95%, and the last participant demonstrating a reduction of approximately 70% to date.

Dr. Alan Taylor, Executive Chairperson of Clarity Pharmaceuticals, expressed his enthusiasm about these developments. He stated, "The outcomes observed in Cohort 2 are exceptionally promising, and we eagerly anticipate the results from the escalated dosing of 12GBq. Furthermore, we are excited to explore the potential benefits of multi-dosing on prostate cancer patients."

Dr. Taylor also emphasized the rapid pace of recruitment in the dose escalation phase, reflecting the urgent demand for innovative solutions in prostate cancer therapy. He underscored Clarity's commitment to addressing not only the treatment needs of individuals with mCRPC but also the logistical and manufacturing challenges posed by current-generation radiopharmaceuticals. He highlighted the availability of commercial quantities of the 67Cu radioisotope, produced domestically in the US and exclusively supplied by NorthStar, as a significant advancement in this direction.

As the SECuRE trial continues to enroll participants, Dr. Taylor expressed his anticipation for sharing more data on 67Cu SAR-bisPSMA. He reiterated Clarity Pharmaceuticals' dedication to advancing toward commercialization, with the ultimate goal of improving treatment outcomes for individuals affected by cancer.

 

Source: prnewswire.com

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