On November 3, 2020 Clarity Pharmaceuticals, a clinical stage radiopharmaceutical company focused on the treatment of serious disease, reported that treatment has commenced in a 64/67Cu-SARTATETM theranostic trial of paediatric patients with neuroblastoma at Memorial Sloan Kettering Cancer Center (MSK) in New York City (Press release, Clarity Pharmaceuticals, NOV 3, 2020, View Source [SID1234569699]).
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The first patient was treated with 67Cu-SARTATE therapy following a positive diagnostic scan with 64Cu-SARTATE and is progressing through the study assessments as planned. Patient recruitment continues at MSK and will be expanding to other clinical sites across the United States (U.S.) in the coming months (ClinicalTrials.gov Identifier: NCT04023331)1.
"We are very excited to commence the treatment of neuroblastoma patients with SARTATE, especially given the great promise of both the diagnostic and therapeutic products in changing the treatment outcomes in these children," commented Dr Alan Taylor, Clarity’s Executive Chairman. "We are looking forward to building more data as we expand the trial to include additional clinical sites and recruit more patients with high-risk neuroblastoma into the study. We are very hopeful that 64/67Cu-SARTATE will save and improve lives of children with this insidious disease."
The SARTATE neuroblastoma trial uses the next-generation radiopharmaceutical pair of 64Cu-SARTATE and 67Cu-SARTATE to assess and treat paediatric patients with high-risk neuroblastoma. It is a multi-centre, dose-escalation, open label, non-randomised, Phase 1/2a theranostic clinical trial being conducted in the U.S. 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 continued: "Our team is pleased to have received very strong support from our numerous collaborators in the clinical development of 64/67Cu-SARTATE in neuroblastoma. We have also recently been granted Orphan Drug Designation as well as two Rare Paediatric Disease Designations for the diagnostic and therapeutic application of SARTATE in neuroblastoma by the U.S. Food and Drug Administration (FDA). These regulatory milestones will enable us to progress SARTATE through clinical development in a swift and cost-effective manner and make Clarity eligible for two Priority Review Vouchers (PRV) upon FDA marketing approval of the diagnostic and therapeutic products. PRVs, which allow for the faster processing of new drug applications through the FDA, are tradable and currently have a market value of approximately USD100 million each. The awarding of these two PRVs will underpin our extensive theranostic development pipeline as we look to progress treatments in other cancers including prostate and breast, as well as neuroendocrine tumours.
"From all the support and positive feedback from the industry that we have received to date, it is clear that the development of next-generation diagnostic and therapeutic tools as well as novel treatment strategies are imperative to improving treatment outcomes for children with high risk neuroblastoma who currently have very poor prognosis and few treatment options. Clarity and our collaborators remain focused on the important goal of developing better treatments for children with cancer and we look forward to further progressing the development of SARTATE together," Dr Taylor said.