Clarity Pharmaceuticals, a clinical-stage radiopharmaceutical company developing next-generation products to address the growing needs in oncology, announced that it has successfully treated its first participant in cohort 2 of the 64Cu/67Cu SARTATE™ neuroblastoma therapy trial (CL04) at the increased dose level of 175MBq/kg body weight.
Clarity has recently progressed to cohort 2 of the CL04 trial following the completion of cohort 1 where three participants received therapy with 67Cu SARTATE™ at a dose of 75MBq/kg body weight. The Safety Review Committee assessed the data from cohort 1 where no dose limiting toxicities have occurred and recommended to progress the trial to cohort 2, without modification, increasing the dose to 175MBq/kg body weight.
Clarity’s Executive Chairman, Dr Alan Taylor, commented, “We are very excited to dose the first patient in cohort 2 in our neuroblastoma therapy trial in the US, having successfully completed cohort 1 in January 2022. The increase in administered activity between cohorts 1 and 2 is significant in radiation-sensitive disease, such as neuroblastoma, and cohort 2 will see administered activities more than double in comparison to cohort 1. We look forward to continuing recruitment in cohort 2 at all five clinical sites in the US, building upon the encouraging initial data from cohort 1 and further gathering evidence of diagnostic and therapeutic benefits of the SARTATE™ product for the treatment of children with neuroblastoma.”
The CL04 trial is a theranostic (diagnosis and therapy) trial in paediatric patients with high-risk neuroblastoma (NCT04023331). It is a multi-centre, dose-escalation, open label, non-randomised, Phase 1/2a clinical trial with up to 34 participants conducted at five clinical sites in the US.
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. 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%.
In 2020, the US Food and Drug Administration (FDA) awarded Clarity two Orphan Drug Designations (ODDs), one for 64Cu SARTATE™ as a diagnostic agent for the clinical management of neuroblastoma and one for 67Cu SARTATE™ as a therapy of neuroblastoma, as well as two Rare Paediatric Disease Designations (RPDDs) for these products. Should Clarity be successful in achieving US FDA New Drug Applications for these two products, RPDDs may potentially allow the Company to access a total of two tradeable Priority Review Vouchers (PRVs) which most recently traded at USD110M per voucher.