On June 8, 2021 Clarity Pharmaceuticals, a clinical stage radiopharmaceutical company focused on the treatment of serious disease, reported that its clinical trial of 64/67Cu SARTATE for paediatric patients with neuroblastoma has been expanded to include five sites in the U.S (Press release, Clarity Pharmaceuticals, JUN 8, 2021, View Source [SID1234583704]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are very excited to expand into additional clinical sites which are now open for recruitment in the trial of Clarity’s lead product in neuroblastoma," commented Dr Alan Taylor, Clarity’s Executive Chairman. "Some of the initial data we have received to date from our first clinical site has been shared at one of the industry’s leading conferences, the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Mid-Winter Meeting 2021 and was very well received. We look forward to continuing the 64/67Cu SARTATE clinical trial in this important patient population in some of the leading cancer centres in the U.S."

The 67Cu SARTATE trial is a Peptide Receptor Radionuclide Therapy 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 with the following confirmed clinical sites:1

Memorial Sloan Kettering Cancer Centre (MSK);
Cincinnati Children’s Hospital Medical Centre;
Medical University of South Carolina;
University of Texas Southwestern Medical Centre; and
University of Wisconsin.
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: "We are very pleased to have received strong support on the development of 64/67Cu SARTATE for neuroblastoma to date from numerous supporters, such as the five clinical sites, Clarity’s team, our collaborators, and the U.S. Food and Drug Administration in granting both diagnostic 64Cu SARTATE and therapeutic 67Cu SARTATE products Orphan Drug Designations and Rare Paediatric Disease Designations. We believe this highlights the importance of SARTATE development in this important patient population to improve the prognosis of children with high-risk neuroblastoma, where current treatment strategies are limited. We are looking forward to further progressing this trial at five clinical sites and getting closer to our ultimate goal of better treating children and adults with cancer."

References
ClinicalTrials.gov Identifier: NCT04023331
Nadja C. Colon and Dai H. Chung 2011, "Neuroblastoma", Advances in Pediatrics, <View Source>
Valeria Smith and Jennifer Foster 2018, "High Risk Neuroblastoma Treatment Review", Children, <View Source>