On August 23, 2022 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported it has completed cohort 2 and advanced to cohort 3 in the theranostic 64Cu/67Cu SARTATE neuroblastoma trial (CL04 trial) (Press release, Clarity Pharmaceuticals, AUG 23, 2022, View Source [SID1234618559]).

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The independent Safety Review Committee (SRC) assessed the safety data from cohort 2 in all three participants, confirming no Dose Limiting Toxicities (DLTs) occurred following the administration of a single therapy cycle of 67Cu-SARTATE. The SRC has recommended the trial progress to cohort 3, without modification, increasing the 67Cu SARTATE dose from 175MBq/kg body weight in cohort 2 to 275MBq/kg body weight in cohort 3. Additional therapy cycles of 67Cu SARTATE have been requested by clinical sites and are being administered to participants in cohorts 1 and 2. Subsequent therapy cycles are contingent on the Investigators assessment that the participant is demonstrating therapeutic benefit.

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "Our team of colleagues and collaborators are very excited to advance the SARTATE product in neuroblastoma, an aggressive childhood cancer. With cohort 2 of this theranostic trial now completed, we look forward to exploring the therapeutic benefits of using an increased dose of 67Cu SARTATE in these children, where no other options are available. The further increase in dose between cohorts 2 and 3 is significant, and we look forward to analysing the safety and efficacy data in these higher-level cohorts in neuroblastoma, a radiation sensitive disease.

"We are also pleased with the speed of recruitment in cohort 2 and have been able to close this cohort in 6 months. The increased pace of recruitment is due to the subsided effects of the global pandemic. We continue to progress the trial at some of the leading cancer centres in the US and will aim to open additional clinical sites in the US over the coming months to further accelerate the speed of recruitment in this trial.

"Improving treatment outcomes of children with cancer is at the heart of our mission and something we are very passionate about. As such, we hope that Clarity will be able to continue building upon the mounting diagnostic and therapeutic benefits of the SARTATE products and improve the treatment paradigm for children with this insidious disease," said Dr Taylor.

About CL04
The CL04 trial is a Phase I/IIa theranostic (diagnosis and therapy) trial in paediatric patients with high-risk neuroblastoma using 64Cu/67Cu SARTATE in the US (NCT04023331)1. It is a multi-centre, dose-escalation, open label, non-randomised clinical trial with up to 34 patients currently conducted at five clinical sites in the US, with additional US clinical sites opening for recruitment in the coming months.

About SARTATE
SARTATE is a next generation, highly targeted theranostic radiopharmaceutical. It is being developed for diagnosing, staging and subsequently treating cancers that express somatostatin receptor 2 (SSTR2), including neuroblastoma and neuroendocrine tumours (NETs). Like all Clarity products, the SARTATE product can be used with copper-64 (64Cu) for imaging (64Cu SARTATE) or copper-67 (67Cu) for therapy (67Cu SARTATE).

About Neuroblastoma
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

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 marketing approval from US FDA for these two products, RPDDs may allow the Company to access a total of two tradeable Priority Review Vouchers (PRVs) which most recently traded at USD110M per voucher.4