Clinical-stage radiopharmaceutical company Clarity Pharmaceuticals (ASX:CU6) has received confirmation from the US FDA that the diagnostic 64Cu SAR-bisPSMA trial (COBRA) may proceed.
Executive chairman Dr Alan Taylor said, “We are excited to be progressing this stand-alone diagnostic trial following a Study May Proceed letter from the US FDA as we head towards registering this product in the US. Following this exciting news, we are now planning to commence recruitment in the trial in the second quarter of CY2022."
COBRA (Copper-64 SAR-BisPSMA in Biochemically Recurrent prostAte cancer) is a Phase I/II Positron Emission Tomography (PET) trial of participants with biochemical recurrence (BCR) of prostate cancer following definitive therapy.
It is a multi-centre, single-arm, non-randomised, open-label trial of 64Cu-labelled SAR-bisPSMA in up to 50 participants.
The company said the primary objectives of the trial are to investigate the safety and tolerability of 64Cu-SAR-bisPSMA as well as its ability to correctly detect recurrence of prostate cancer.
COBRA is the third clinical trial of the optimised SAR-bisPSMA agent in prostate cancer.
Dr Taylor continued, “The preliminary data from our SAR-bisPSMA trials in Australia and the US look very promising and the high uptake and retention of SAR-bisPSMA shown in preclinical and clinical trials to date may lead to improved detection in patients with prostate cancer, particularly those with low PSA levels. Our team and our collaborators are excited to commence the COBRA trial, generating more data to progress the development of SARbisPSMA as we move this product closer to registration in the US.
“We also look forward to further validating our on-demand distribution model as the trial sites will be supplied with ready-to-use cGMP 64Cu-SAR-bisPSMA product. Clarity’s vision is to move the diagnostic field towards centrally manufactured products that can be delivered on demand, shifting away from the supply constraints of the first generation of PET agents such as gallium-68 and fluorine-18 and the burdensome challenges of short-lived radionuclides. But most importantly, on-demand central manufacture of radiopharmaceuticals could potentially improve patient care by focusing on the needs of patients and their treating staff, delivering critical treatments that are safe and efficacious, on time and at any treatment centre with a PET camera.”