Category Archives: News

Initial COBRA results: Clarity’s SAR-bisPSMA is safe and highly effective in detecting tumours in prostate cancer patients. Phase 3 planning underway.

Sydney, Australia 15 February 2024 Highlights Initial data from Clarity’s diagnostic Phase 1/2 trial, COBRA, confirms 64Cu-SAR-bisPSMA is safe and highly effective in detecting prostate cancer (PC) lesions in patients with biochemical recurrence (BCR). Confirmed unique benefit of 64Cu-SAR-bisPSMA for next-day imaging in this patient population, with more lesions and more patients with a positive…

Resignation of Non-Executive Directors

Sydney, Australia 16 January 2024 Clarity Pharmaceuticals (ASX: CU6) (“Clarity”, “the Company”), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, advises that Clarity’s Non-Executive Director, Ms Cheryl Maley, is resigning effective immediately to focus on her new full-time role as Chief…

First patient dosed in Clarity’s registrational Phase III prostate cancer trial with Cu-64 SAR-bisPSMA

Sydney, Australia 23 December 2023 Highlights First patient safely dosed in the pivotal Phase III 64Cu-SAR-bisPSMA diagnostic trial. The aim of the CLARIFY trial is to detect regional nodal metastases in participants with prostate cancer prior to radical prostatectomy. Final results from the CLARIFY trial are intended to provide sufficient evidence to support an application…

Recruitment successfully closes early for a diagnostic Phase II trial in neuroendocrine tumours

Sydney, Australia 19 December 2023 Clarity Pharmaceuticals (ASX: CU6) (“Clarity”, “the Company”), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, is pleased to announce the early recruitment closure for its Phase II diagnostic 64Cu-SARTATE trial, DISCO (NCT04438304)1, for patients with known or…

Registrational Phase III CLARIFY trial in prostate cancer commences

Sydney, Australia 30 November 2023 Clarity Pharmaceuticals (ASX: CU6) (“Clarity”, “the Company”), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, is pleased to announce it has commenced its registrational Phase III 64Cu-SAR-bisPSMA diagnostic trial in prostate cancer, CLARIFY (NCT06056830)1, with the…

First patient with metastatic prostate cancer to receive 2 doses of Cu-67 SAR-bisPSMA achieves undetectable PSA level

Sydney, Australia 30 November 2023 Highlights Undetectable levels of Prostate Specific Antigen (PSA) have been reported from the first patient with metastatic castrate-resistant prostate cancer (mCRPC) to ever receive two cycles of Clarity’s 67Cu-SAR-bisPSMA at the 8GBq dose level. PSA is a marker of tumour burden, clinical response to treatment and an indicator of the…

Clarity’s theranostic prostate cancer trial progresses at the highest dose level cohort

Sydney, Australia 29 November 2023 Highlights Cohort 3 of the theranostic SECuRE trial investigating 64Cu/67Cu-SAR-bisPSMA in metastatic castrate-resistant prostate cancer (mCRPC) has enrolled and treated 3 participants who received therapy with 67Cu-SAR-bisPSMA at the highest dose level of 12GBq.­ No dose limiting toxicities (DLTs) have been reported to date. Only one participant had one adverse…

Recruitment target achieved for Phase II SAR-Bombesin prostate cancer trial

Sydney, Australia 7 November 2023 Clarity Pharmaceuticals (ASX: CU6) (“Clarity”), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, is pleased to announce that 50 patients have now been imaged with 64Cu-SAR-Bombesin in its United States-based diagnostic  trial, SABRE (NCT05407311)1, for participants…

Clarity and PSI kick off SAR-bisPSMA Phase III

Sydney, Australia 26 October 2023 Clarity Pharmaceuticals (ASX: CU6) (“Clarity”, “the Company”), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, and PSI CRO AG (“PSI”), a global contract research organisation committed to on-time enrollment in radiopharmaceutical clinical trials, have entered into…

First patient treated with Cu-67 SAR-Bombesin in theranostic prostate cancer trial

Sydney, Australia 3 October 2023 Clarity Pharmaceuticals (ASX: CU6) (“Clarity”), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer,  is pleased to announce the dosing of the first patient in its theranostic 64Cu/67Cu SAR-Bombesin Phase I/II trial in metastatic castrate resistant prostate…