Positive guidance from US FDA on Cu-64 SAR-bisPSMA Phase III trial in prostate cancer

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, “We are very excited to progress our Phase III trial and are appreciative of the time and valuable guidance the FDA has provided in relation to our 64Cu SAR-bisPSMA program during the end of phase meeting. The initiation of the CLARIFY trial is supported by compelling preclinical and clinical trial data. We would like to thank everyone who contributed to this exciting milestone, from our scientific collaborators at the University of Melbourne, who helped us overcome the low uptake and washout of first generation PSMA agents by assisting us in making an optimised PSMA agent for imaging and therapy, to the patients who participate in our clinical trials and to our incredible team and collaborators who work tirelessly towards our mutual goal of improving treatment outcomes for patients with PC. With this product, in both our diagnostic and therapy trials, we are now getting very close to achieving this goal.