Clinical-stage radiopharmaceutical company Clarity Pharmaceuticals (ASX:CU6) has announced that its Phase 2 diagnostic 64Cu SARTATE trial for patients with known or suspected neuroendocrine tumours (NETs) has reached the 50 per cent recruitment milestone.
The company 32 out of 63 participants have been enrolled and imaged.
DISCO, which is derived from 'Diagnostic Imaging Study of 64Copper-SARTATE Using PET on Patients With Known or Suspected Neuroendocrine Tumours', is assessing the performance of Clarity’s SARTATE imaging product as a potential new way to help diagnose and manage NETs.
It is a Phase 2 study in up to 63 patients with Gastroenteropancreatic NETs (GEP-NETs) across four sites in Australia, comparing the diagnostic performance of 64Cu SARTATE at four and 20 hours post-administration to the current standard of care, 68Ga DOTATATE, at one hour.
Clarity executive chairman Dr Alan Taylor said, “We are pleased with the progress of our SARTATE product. There is a clear unmet need in the NET indication with misdiagnosis and delay in diagnosis remaining very common.
"The vast majority of patients have the cancer spread to distant parts of the body by the time of diagnosis, which significantly affects treatment outcomes for people with NETs. Clarity continues to build on the promising first-in-human data, indicating the safety and potential effectiveness of the product as a new way to detect NETs.
"Combined with the logistical and supply benefits of central manufacturing enabled by the use of Targeted Copper Theranostics, SARTATE holds promise of delivering timely and crucial diagnostic scans to patients and their treating staff, bringing us closer to our ultimate goal of improving treatment outcomes for children and adults with cancer.”