- Clarity Pharmaceuticals (CU6) gains a tick of approval to begin a phase three trial called CLARIFY, assessing its 64Cu SAR-bisPSMA diagnostic in prostate cancer
- The new trial follows a successful end-of-phase meeting with the US FDA and will treat patients with high-risk PC before receiving a radical prostatectomy
- The phase three trial follows positive results from CU6’s previously completed PROPELLER trial
- Clarity expects its single-arm, multi-centre, blinded-review, phase three diagnostic performance study to begin patient recruitment in late 2023
- CU6 shares are up 4.05 per cent, trading at 77 cents at 11:22 am AEST
Clarity Pharmaceuticals (CU6) has gained approval to begin a phase three trial called CLARIFY, assessing its 64Cu SAR-bisPSMA diagnostic in prostate cancer (PC).
The new trial follows a successful end-of-phase meeting with the US Food and Drug Administration (FDA) and will treat patients with high-risk PC before receiving a radical prostatectomy.
Clarity expects its single-arm, multi-centre, blinded-review, phase three diagnostic performance trial to begin patient recruitment in late 2023.
“We are very excited to progress our phase three 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,” CU6 Executive Chairperson Dr Alan Taylor said.
“The positive results from our completed PROPELLER1 trial showed that 64Cu SAR bisPSMA is safe, and its uptake in PSMA-expressing cancer lesions was significantly higher compared to the approved standard-of-care PSMA imaging agent for PC in Australia and the US.
“Furthermore, we believe that the additional shelf-life of up to 48 hours could not only allow clinics greater flexibility in scheduling scans but could also improve patient’s access to care in clinics and geographic areas where the short half-life of current PSMA PET tracers restricts the use of radiopharmaceuticals.”
The company’s phase three trial design is based on positive results from its previously completed PROPELLER trial.
CU6 will monitor 383 prostate cancer patients across multiple sites, aimed to commence in late 2023.
CU6 shares were up 4.05 per cent, trading at 77 cents at 11:22 am AEST.