Sydney, Australia 3 September 2019 – Clarity Pharmaceuticals, a radiopharmaceutical company focused on the treatment of serious disease, is pleased to announce that it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for a Phase 1-2a theranostic (i.e. diagnostic and therapy) trial with 64Cu-SARTATE™ and 67Cu-SARTATE™ in paediatric patients.
This trial will be using Clarity’s lead product, SARTATE™, administered to paediatric patients with somatostatin receptor-2 positive, relapsed or refractory, high-risk neuroblastomas. It is a multi-centre, dose escalation, open-label, non-randomised, Phase 1-2a theranostic clinical trial planned for up to 34 patients using 64Cu-SARTATE™ for PET imaging and 67Cu-SARTATE™ for therapy.
Neuroblastoma is a disease that occurs most often in infants and young children, usually in children younger than 5 years old. It is the most common type of cancer to be diagnosed in the first year of life and accounts for around 13% of paediatric cancer mortality. High-risk neuroblastoma accounts for approximately 45% of all neuroblastoma cases. Patients with high-risk neuroblastoma have the lowest 5-year survival rates at 40%-50%.
This study is supported by a human imaging study in 10 adults with neuroendocrine tumours and preliminary results of a first-in-human study of adult patients with meningioma, who were administered a diagnostic dose of 64Cu-SARTATE™ followed by up to four doses of 67Cu-SARTATE™.
Dr Alan Taylor, Clarity’s Executive Chairman, said “This IND application is a major milestone for our team and our collaborators who have worked diligently to prepare our first submission to the US FDA. The IND submission summarises our extensive preclinical, clinical and manufacturing efforts in the field of copper based theranostics. We hope to receive a confirmation from the FDA shortly in order to progress this trial at major cancer centres in the United States and advance closer to our ultimate goal of better treating children and adults with cancer.”
Media Contact
Dr Alan Taylor
Executive Chairman
Ph: +61 (0)413 871 165
E: ataylor@claritypharm.com
About Clarity
Clarity is a personalised medicine company focused on the treatment of serious diseases. The Company is a leader in innovative radiopharmaceuticals, developing targeted therapies for the treatment of cancer and other serious diseases in adults and children.
