Clarity says recruitment target achieved for Phase II SAR-Bombesin prostate cancer trial

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Radiopharmaceuticals company Clarity Pharmaceuticals (ASX:CU6) has announced that 50 patients have been imaged with 64Cu-SAR-Bombesin in its US-based diagnostic trial, SABRE.

The trial is for patients with PSMA-negative prostate cancer. It is a multi-centre, single-arm, non-randomised, open-label trial of 64Cu-labelled SAR-Bombesin.

The company said the primary objectives of the trial are to investigate the safety and tolerability of the product as well as its ability to detect recurrence of prostate cancer correctly.

According to Dr Andrei Iagaru, the trial's lead principal investigator for the trial, “We are very excited to have successfully imaged 50 participants in the SABRE trial, which further explores the clinical benefits of the innovative SAR-Bombesin product. Preclinical and clinical findings thus far indicate that SAR-Bombesin holds significant potential for improving the diagnosis and treatment of prostate cancer, giving hope to clinicians and patients who have no other suitable diagnostic options available. Being able to now visualise the gastrin-releasing peptide receptor (GRPr) expressing lesions with SAR-Bombesin has the potential to change the entire treatment paradigm for patients. With more tools to detect prostate cancer that may not be visible with other imaging agents, we may be able to better diagnose and offer more effective treatment for their disease.

“Unique to Clarity’s SAR Technology is the ability to image patients at later timepoints due to the optimal half-life of 64Cu. As such, 64Cu-SAR-Bombesin enables imaging not only on the day of product administration, but also at later timepoints, which may add utility to the diagnosis of cancerous lesions. We look forward to analysing data from the SABRE trial in hopes of continuing to validate the benefits associated with this agent and better managing the patients that have few options at present in the face of a devastating diagnosis.”

Clarity’s executive chairman, Dr Alan Taylor, said, “We are pleased to have reached our recruitment target in our Phase II SABRE trial with the 64Cu-SAR-Bombesin imaging product. SAR-Bombesin has already resulted in improvements to the management of prostate cancer for patients with PSMA-negative or low PSMA expressing lesions through our clinical program. We believe this product has immense potential, both as a theranostic and as a stand-alone diagnostic, as it targets GRPr, which is present in a number of cancers, potentially broadening its use beyond PSMA-negative prostate cancer.

“The successful C-BOBCAT and BOP investigator-initiated trials have already showed the utility of SAR-Bombesin and its potential to identify disease in some patient subgroups where conventional diagnostic imaging has failed. We look forward to reporting further data relating to the potential advantages of SAR-Bombesin and, subject to these results, moving this product into a registrational Phase III trial.”