Author Archives: Lisa Sadetskaya

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…

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…

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…

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…

First participant treated in the highest dose cohort of neuroblastoma trial

Sydney, Australia 25 August 2023 Highlights First participant of cohort 4 of the theranostic CL04 trial investigating 64Cu/67Cu SARTATE in neuroblastoma has been treated at the highest dose cohort of 375MBq/kg body weight. Cohort 3 was successfully completed in 3 participants with neuroblastoma who received therapy with 67Cu SARTATE at a dose of 275MBq/kg body…

First participant treated at the highest dose level in Clarity’s theranostic prostate cancer trial

Sydney, Australia 25 August 2023 First participant of cohort 3 in the theranostic SECuRE trial investigating 64Cu/67Cu SAR-bisPSMA in metastatic castrate-resistant prostate cancer (mCRPC) has been treated at the highest dose level of 12GBq. Cohort 2 was recently completed in 3 participants who received therapy with 67Cu SAR-bisPSMA at the dose level of 8GBq. Data…

Clarity’s theranostic prostate cancer trial advances to highest dose level

Sydney, Australia 10 August 2023 Highlights Cohort 2 of the theranostic SECuRE trial investigating 64Cu/67Cu SAR-bisPSMA in metastatic castrate-resistant prostate cancer (mCRPC) has been completed in 3 participants who received therapy with 67Cu SAR-bisPSMA at the dose level of 8GBq. No dose limiting toxicities (DLTs) have been reported in cohort 2. The Safety Review Committee…

Final cohort opens for recruitment in the CL04 theranostic trial in paediatric neuroblastoma

Sydney, Australia 26 July 2023 Highlights Cohort 3 completed in participants with neuroblastoma who received therapy with 67Cu SARTATE at a dose of 275MBq/kg body weight. Safety Review Committee (SRC) has recommended the trial continues with the dose escalation phase as planned. Recruitment of cohort 4 is open at clinical sites in the US at…

Clarity reaches 50% recruitment milestone for Phase II SABRE prostate cancer trial

Sydney, Australia 24 July 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 Phase II US-based diagnostic 64Cu SAR-Bombesin trial (SABRE NCT05407311)1 for patients with prostate cancer has reached its…