SYDNEY, July 23, 2020 /PRNewswire/ -- Clarity Pharmaceuticals, a radiopharmaceutical company focused on the treatment of serious disease, is pleased to announce that it has opened its trial of 67Cu-SARTATE™ for paediatric patients with neuroblastoma at Memorial Sloan Kettering Cancer Center (MSK) in New York City and recruitment has commenced.
"We are very excited to commence recruitment for our trial in this very important patient population," commented Dr Alan Taylor, Clarity's Executive Chairman. "The opening of the trial and commencement of recruitment comes shortly after the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation status for both the diagnostic and therapeutic applications of SARTATE™ in neuroblastoma. Achieving these milestones despite the challenging conditions presented by the coronavirus pandemic signifies strong support from the FDA, MSK and Clarity's collabomsrators and importantly our team which relates to the importance of progressing the development of SARTATE™ in this vulnerable patient population."
67Cu-SARTATE™ trial is a Peptide Receptor Radionuclide Therapy (PRRT) administered to paediatric patients with high-risk neuroblastoma. It is a multi-centre, dose-escalation, open label, non-randomised, Phase 1/2a theranostic clinical trial at MSK.1 MSK is the world's oldest and largest private cancer centre. It has devoted more than 135 years to exceptional patient care, innovative research, and outstanding educational programs.
Neuroblastoma most often occurs in children younger than 5 years of age and presents when the tumour grows and causes symptoms. It is the most common type of cancer to be diagnosed in the first year of life and accounts for around 15% of paediatric cancer mortality.2 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%.3
Dr Taylor said: "At this time, children with high-risk neuroblastoma have poor prognosis as current treatment strategies have limited effect in patients with late-stage disease where cancer has metastasised. It is evident that the development of new treatment approaches and strategies is crucial to improving treatment outcomes for this patient population. We are looking forward to progressing the development of SARTATE™ and getting closer to our ultimate goal of better treatment of children and adults with cancer."
References
1. ClinicalTrials.gov Identifier: NCT04023331
2. Nadja C. Colon and Dai H. Chung 2011, "Neuroblastoma", Advances in Pediatrics, <https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3668791/>
3. Valeria Smith and Jennifer Foster 2018, "High Risk Neuroblastoma Treatment Review", Children, <https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6162495/>
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.
www.claritypharmaceuticals.com
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![Figure 1. Images show considerable reduction in lesion uptake (64Cu-SAR-bisPSMA PET) following 4 doses of 67Cu-SAR-bisPSMA (4GBq each; PET conducted in July 2024, approximately 14 months post-fourth cycle). Reduction in uptake (maximum standardised uptake value [SUVmax]) and tumour volume: 72.5% and 41.6%, respectively. New bone lesions identified (red circles) in the most recent image prior to the fifth dose. The fifth dose was delivered on 30 July 2024, with PSA having fallen 47.5% as of 24 September 2024 and trending downward. Post-treatment scans are pending.](https://mma.prnasia.com/media2/2531886/Images_show_considerable_reduction_lesion_uptake__64Cu_SAR_bisPSMA_PET__4_doses.jpg?p=medium600)
