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…

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…

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…

Clarity update on NorthStar copper-67 production

Sydney, Australia 4 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 provide an update on copper-67 (Cu-67 or 67Cu) production by NorthStar Medical Radioisotopes, LLC (NorthStar). NorthStar, a global innovator in the…

World leading expert in copper-67 joins Clarity’s SAB

Sydney, Australia 1 March 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 the world leading expert in copper-67 isotope (Cu-67 or 67Cu) production, Jon Stoner, to Clarity’s Scientific Advisory…

Clarity reaches 50% recruitment milestone for DISCO neuroendocrine tumour diagnostic Phase II trial

Sydney, Australia 16 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 Phase II diagnostic 64Cu SARTATE trial (DISCO NCT044383041) for patients with known or suspected neuroendocrine tumours (NETs) has reached the…