Currently, early detection of its spread to lymph nodes and other parts of the body is not possible with standard PET scans and by the time it is detected, treatment may not be effective. Phase III trials have started.
Cu6 is also developing other products for the early detection of other cance
Clarity Pharmaceuticals Ltd (ASX: CU6)
Clarity Pharmaceuticals share price has been on a positive run since late 2023. The share price increased 52.6% from 31 December 2023 to 29 February 2024 and is up 229.5% over the 12-months to 29 February 2024.
Clarity Pharmaceuticals is a clinical stage radiopharmaceutical company developing next generation products to address the growing need for better diagnostics and treatments in oncology through its Targeted Copper Theranostic (TNT) platform.
The Company has a strong balance sheet, with over $37.9 million in cash as at 31 December 2023. The addition of the RDTI of ~$10 million is expected to provide a cash runway into late 2024.
The Company has a number of ongoing clinical trials for its three core products, SAR-bisPSMA, SAR-Bombesin and SARTATE, each of which contain a different targeting agent and bind to different receptors that are present on different cancer cells.
In December 2023, the Company dosed the first patient in the Phase III CLARIFY trial. The trial is a non-randomised, open-label trial that will include 383 participants. The aim of the trial is assess the diagnostic performance of 64Cu-SAR-bisPSMA PET
to detect prostate cancer within the pelvic lymph nodes. The CLARIFY study is investigating if delayed imaging allows for improved disease detection. The longer half-life of 64Cu may not only allow the detection of additional cancerous lesions on delayed imaging but also provide a timely supply of products covering a broad geographic area and flexibility for the scheduling of patients.
According to the Company, currently approved diagnostic products have low sensitivity, meaning some lesions may remain undetected. Clarity’s SAR-bisPSMA product was developed in response to this issue. The dual PSMA targeting agent and delayed imaging feature have the potential to improve product uptake and retention in prostate cancer lesions.
In February, the Company announced the initial results of the Phase 1/2 COBRA trial, which showed that the Company’s SAR-bisPSMA is safe and effective in detecting tumours in prostate cancer patients with biochemical recurrence. In trial participants where the standard of care imaging was unable to detect any lesions, up to ~60% had lesions identified by same-day 64CU-SAR-bisPSMA imaging and up to 80% on next-day imaging, with high specificity.
The possibility of performing next-day imaging is a feature not available to currently approved PSMA-targeted PET products and unique to 64Cu-based SAR diagnostics due to the optimal half-life of 64Cu and the ability of the SAR Technology to prevent leakage of copper isotopes from the radiopharmaceutical in-vivo. The COBRA trial confirmed the benefits of delayed imaging in this patient group as more lesions and more patients with a positive scan were identified on next-day imaging. These results have seen the Company commence plans for a Phase III trial.
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