Positive guidance from US FDA on Cu-64 SAR-bisPSMA Phase III trial in prostate cancer

Sydney, Australia 4 July 2023 Highlights FDA agreement for a pivotal Phase III trial for 64Cu SAR-bisPSMA diagnostic in prostate cancer Phase III trial design based on 64Cu SAR-bisPSMA data package, including positive results from the completed PROPELLER trial A total of 383 prostate cancer patients to take part in a pivotal, non-randomised, single-arm, open-label,…

Clarity establishes a US Center of Excellence for Targeted Copper Theranostics

Sydney, Australia 28 June 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 establishment of a Center of Excellence at the Idaho Accelerator Center (IAC), a research facility operated by Idaho State…

NorthStar Medical Radioisotopes Now Routinely Manufacturing High Activity Copper-67 on its Electron Accelerators for Clarity Pharmaceuticals’ Therapy Clinical Programs

Sydney, Australia 27 June 2023 Highlights NorthStar is now producing high activity, high specific activity and high purity copper-67 (Cu-67 or 67Cu) suitable for Clarity’s ongoing clinical programs. Initial shipments by NorthStar for Clarity’s Targeted Copper Theranostic (TCT) clinical programs were completed under the exclusive supply agreement. Large-scale production of Cu-67 uses a highly efficient,…

Clarity commences COMBAT theranostic prostate cancer trial in the US

Sydney, Australia 20 June 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 it has commenced its 64Cu/67Cu SAR-Bombesin Phase I/II trial in metastatic castrate resistant prostate cancer (mCRPC) with the opening…

Clarity expands supply of Cu-64 SAR-bisPSMA for pivotal Phase III clinical trials

Sydney, Australia 14 June 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 PETNET Solutions Inc, a Siemens Healthineers Company – a global positron emission tomography (PET) radiopharmaceutical network and the leading manufacturer…

Recruitment complete for Phase II prostate cancer trial

Sydney, Australia 7 June 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 completion of recruitment for the Phase II investigator initiated diagnostic trial, BOP (NCT05613842)1, evaluating its 64Cu-SAR-Bombesin product…

Oncology Expert Joins Clarity as Senior Medical Director

Sydney, Australia 2 May 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 appointment of Dr Othon Gervasio as Senior Medical Director, effective immediately. Dr Gervasio is an experienced senior leader with…

Clarity Receives $6.7 million R&D Tax Incentive Refund

Sydney, Australia 18 April 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 it has received a $6,726,900 Research and Development (R&D) Tax Incentive refund as part of the Australian Federal Government’s…

US based COBRA diagnostic prostate cancer trial reaches recruitment target

Sydney, Australia 9 February 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 its diagnostic 64Cu SAR-bisPSMA trial COBRA (NCT05249127)1 for patients with prostate cancer has reached its recruitment target. COBRA (Copper-64 SAR-bisPSMA in Biochemically Recurrent prostAte…