Sydney, Australia 15 August 2017 – Clarity Pharmaceuticals, a radiopharmaceutical company focused on the treatment of serious disease, is pleased to announce that it has been granted Ethics Approval by The Children’s Hospital at Westmead for its SARTATE™ Kids clinical trial for neuroblastoma.
Clarity filed its ethics submission to the Sydney Children’s Hospital Network Human Research Ethics Committee in March 2017 and received approval in August 2017. Clarity is currently completing centralised product manufacturing validation and is planning to complete site set up by the end of August 2017, followed by trial recruitment in September 2017.
SARTATE™ Kids is copper-64 labelled MeCOSar-Tyr3-octreotate (64Cu-SARTATE). It is a positron emission tomography (PET) diagnostic, used for the localisation of somatostatin receptor positive cancers such as neuroblastomas. Clarity has previously conducted a first-in-human clinical trial of 64Cu-SARTATE in neuroendocrine tumour patients, completed in 2015 by Professor Rodney Hicks at the Peter MacCallum Cancer Centre, Melbourne Australia. Trial results, along with research to date, suggest that 64Cu-SARTATE™ would be an ideal diagnostic for neuroblastoma, and the data from this trial will help pave the way for the use of copper-67 labelled SARTATE™ for therapy in this patient population. Copper-67 labelled SARTATE™ has been shown to be efficacious in a number of pre-clinical models and is an ideal candidate for therapeutic treatment in this patient population.
Neuroblastoma 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. It is a disease in which malignant cells form in early nerve tissue (neuroblasts) of the sympathetic nervous system and can be found anywhere along this system, including the adrenal glands, neck, chest, or spinal cord. This cancer occurs most often in infants and young children, usually in children younger than 5 years old.
The Children’s Hospital at Westmead provides quality care and clinical services to 80,000 sick and injured children each year. It is the largest paediatric centre in New South Wales and provides excellent care for children from Australia and across the Pacific Rim.
Clarity’s Executive Chairman, Dr Alan Taylor, commented “The ethics approval represents an important milestone in our clinical trial process and we are excited to finalise our preparation for the SARTATE™ Kids trial. This step will enable us to progress further in our aspiration to develop treatments for children with cancer that would not only lead to better efficacy in fighting the disease, but also potentially reduce the significant side-effects of current treatments and provide a higher quality of life post treatment for these children.”
Clarity Pharmaceuticals is a personalised medicine company focused on the treatment of serious disease. The Company is a leader in innovative radiopharmaceutical technology, developing targeted therapies and assisting in the drug development pipeline of novel therapies for companies globally.
Dr Alan Taylor
Ph: +61 (0)413 871 165