Clarity Pharmaceuticals (ASX:CU6) announced a breakthrough in its mission to improve cancer treatment outcomes, confirming that the registrational Phase 3 AMPLIFY trial has met its recruitment targets.
Following strong demand across clinical sites in both Australia and the United States, the study has consented more patients than its initial target of 220.
Enrolment has now been paused while the final screening assessments are completed.
The AMPLIFY trial evaluates the diagnostic effectiveness of 64Cu-SAR-bisPSMA, a next-generation positron emission tomography imaging agent.
The study specifically targets men with biochemical recurrence of prostate cancer—those with rising PSA levels after initial treatment.
By comparing imaging results from Day 1 (same-day) and Day 2 (next-day), researchers aim to demonstrate the agent’s superior ability to detect recurrent cancer cells compared to current standards of care.
Dr Alan Taylor, Executive Chairperson of Clarity, highlighted the speed of the achievement, noting that the recruitment milestone was reached in just nine months.
The rapid pace is particularly notable given the presence of existing products in the market.
As a pivotal trial, the data generated from AMPLIFY will be used to support a formal application to the US Food and Drug Administration for the approval of 64Cu-SAR-bisPSMA.
At the time of reporting, Clarity Pharmaceuticals' share price was $3.39.