The ASX 200 index is back on form and pushing higher on Thursday.
While that is good, one ASX 200 stock is rising more than most today and has jumped 9% in morning trade.
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Which ASX 200 stock?
The ASX 200 stock that is catching the eye today is Clarity Pharmaceuticals Ltd (ASX: CU6).
This morning, the clinical-stage radiopharmaceutical company's shares have risen 9.5% to $3.74 following the release of a promising announcement.
According to the release, the Co-PSMA (NCT06907641) Investigator-Initiated Trial (IIT) led by Prof Louise Emmett at St Vincent's Hospital Sydney has now completed its study enrolment and all participants have been imaged.
This study is evaluating the performance of the ASX 200 stock's diagnostic product, 64Cu-SAR-bisPSMA, in comparison to standard-of-care (SOC) 68Ga-PSMA-11. This is for the detection of prostate cancer recurrence in patients with low prostatespecific antigen (PSA) who are candidates for curative salvage therapy.
The release notes that the diagnostic capabilities of 64Cu-SAR-bisPSMA compared to SOC diagnostic imaging have been demonstrated in two prospective clinical trials, PROPELLER2 and COBRA3.
Following the positive results of these trials, Clarity is conducting two Phase III registrational trials, CLARIFY4 and AMPLIFY5, in the pre-prostatectomy and BCR settings, respectively. The CLARIFY trial is recruiting patients at St Vincent's Hospital Sydney and this site will also open recruitment for the AMPLIFY trial shortly with Prof Emmett as the principal investigator.
Commenting on the news, the ASX 200 stock's executive chair, Dr Alan Taylor, said:
We are excited about this important milestone in the Co-PSMA trial and the development program of 64Cu-SAR-bisPSMA. With mounting data of the benefits that 64Cu-SAR-bisPSMA could offer compared to SOC diagnostic imaging, demonstrated in the PROPELLER and COBRA trials, we eagerly anticipate the results from this head-to-head trial against 68Ga-PSMA-11.
The high volume of patients imaged in recent months at a single site reflects the high unmet need for more effective diagnostic tools for men with rising PSA following radical prostatectomy. Visualising cancer early in these patients is crucial for physicians to determine the optimal course of treatment before the cancer spreads, leading to improved outcomes, including the potential for cure.
The Principal Investigator in the Co-PSMA trial, Prof Louise Emmett, spoke positively about the trial, stating:
We are pleased to have reached our enrolment target for the Co-PSMA trial. Imaging prostate cancer patients has evolved significantly in recent years, particularly with the development of the current-generation PSMA targeted products. The approved PSMA PET products have high specificity, however, due to their low sensitivity, especially in patients with low PSA, a considerable proportion of patients have no detectable disease on the scans while their PSA continues to rise, indicating recurrence of their cancer.
With no clear visualisation of where the cancer is located, planning effective treatments is challenging. Early intervention is essential in order to achieve cure in BCR, and the need for more sensitive diagnostics remains. This unmet need is what led us to design the Co-PSMA study.
