Author Archives: India Broom Waugh

DISCO topline results: Cu-64 SARTATE is highly effective in detecting tumours in NET patients compared to SOC imaging. Phase III planning underway.

Sydney, Australia 5 June 2025 Highlights Topline data from Clarity’s diagnostic Phase II trial, DISCO, confirms that 64Cu-SARTATE is safe and highly effective compared to standard-of-care (SOC) imaging at detecting lesions in patients with neuroendocrine tumours (NETs). DISCO compared the diagnostic performance of 64Cu-SARTATE at an average of 4 hours (between 3 to 5 hours) and 20…

First patient imaged in Phase III AMPLIFY trial with Cu-64 SAR-bisPSMA PET/CT

Sydney, Australia 29 May 2025 Clarity Pharmaceuticals (ASX: CU6) (“Clarity” or “Company”), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, is pleased to announce that it has imaged the first patient in its registrational Phase III 64Cu-SAR-bisPSMA diagnostic trial in participants with biochemical recurrence…

Registrational Phase III AMPLIFY trial in biochemical recurrence of prostate cancer commences

Sydney, Australia 20 May 2025 Clarity Pharmaceuticals (ASX: CU6) (“Clarity” or “Company”), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, is pleased to announce that it has commenced its second registrational Phase III 64Cu-SAR-bisPSMA diagnostic trial in prostate cancer, AMPLIFY (NCT06970847)1, with the initiation…

Clarity signs Cu-64 Supply Agreement with The University of Queensland

Sydney, Australia 5 March 2025 Highlights Clarity has signed a new agreement with The University of Queensland (UQ) advanced imaging at the Australian Institute for Bioengineering and Nanotechnology (AIBN) for supply of copper-64 (Cu-64 or 64Cu) isotope. The copper-64 supply will be used to expand the manufacturing capability of the diagnostic 64Cu-SAR-bisPSMA product for the…

SECuRE trial update: 92% of pre-chemo participants experience greater than 35% drop in PSA levels across all cohorts. Cohort Expansion Phase commences.

Sydney, Australia 5 March 2025 Highlights Safety Review Committee (SRC) meeting confirms end of the Dose Escalation Phase and commencement of the Cohort Expansion Phase (Phase II stage) of the SECuRE study. Based on the efficacy and safety assessment of all cohorts and the focus on earlier stages of treatment, the SRC confirmed expansion at…

Clarity receives US FDA Fast Track Designation for the treatment of metastatic castration-resistant prostate cancer patients with Cu-67 SAR-bisPSMA

Sydney, Australia 19 February 2025 Clarity Pharmaceuticals (ASX: CU6) (“Clarity” or “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 that the United States (US) Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for 67Cu-SAR-bisPSMA…

Clarity expands pipeline in breast cancer with Cu-64/67 SAR-trastuzumab: Pre-clinical data published and trastuzumab supply agreement in place

Sydney, Australia 11 February 2025 Highlights Clarity renews its focus on the breast cancer market, spearheaded by 64/67Cu-SAR-trastuzumab and reinforced by its SAR-Bombesin, SARTATE and SAR-bisPSMA products in this indication. It is estimated that 316,950 women will be diagnosed with invasive breast cancer in 2025 in the United States (US), with 42,170 dying from the disease1.…

Clarity to present COBRA and CLARIFY abstracts at two world-leading conferences

Sydney, Australia 28 January 2025 Highlights Two abstracts on Clarity’s diagnostic COBRA and CLARIFY trials with 64Cu-SAR-bisPSMA have been accepted for presentation at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) 2025. An abstract on the COBRA study has also been selected for presentation at the American Urological Association (AUA) Annual Meeting…

Clarity receives U.S. FDA Fast Track Designation for Cu-64 SAR-bisPSMA in biochemical recurrence of prostate cancer

Sydney, Australia 24 January 2025 Clarity Pharmaceuticals (ASX: CU6) (“Clarity” or “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 that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for 64Cu-SAR-bisPSMA for positron…

Clarity expands its pipeline with a novel optimised FAP-targeted radiopharmaceutical

Sydney, Australia 18 December 2024 Highlights Clarity has developed a proprietary fibroblast activation protein (FAP)-targeted radiopharmaceutical product that can be used with the perfect pairing of copper isotopes for the diagnosis and treatment of cancer. The product, termed SAR-bisFAP, has shown strong tumour targeting, retention and pharmacokinetic data to date in pre-clinical models. FAP is…