CLEO Selects U.S. Clinical Trial Sites

MELBOURNE, AUSTRALIA, 31 July 2024: Ovarian cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) (CLEO, or the Company) is pleased to announce progress for its U.S. clinical trials in support of its FDA application for its ovarian cancer diagnostic blood test.

• Initial U.S. clinical trial sites contracted following Institutional Review Board (IRB) approval
• 7 sites selected across Texas, Arizona, Florida, Nevada, California, and New York
• First patients being recruited with trials to begin mid-August 2024
• Australian ethics approval also obtained with mirror trial to run at Monash Health.

U.S. Clinical Trial Sites Selected

CLEO is pursuing regulatory approval in the U.S. as the largest diagnostics market in the world. Prior to submission with the Food and Drug Administration (FDA), the Company will complete a study that will benchmark CLEO’s technology through a 500 patient clinical trial. CLEO’s U.S.-based clinical trials manager, Lindus Health, has now obtained Institutional Review Board (IRB) approval for, and formally contracted 7 clinical trial sites across the U.S.

This follows CLEO obtaining IRB approval for its clinical trial design last month. A wide geographic range of sites ensures that a diverse representation of the U.S. population is met. Initial sites that have been selected and contracted are located in Texas, Arizona, Florida (x2), Nevada, California, and New York. First patients are being recruited with the trials to begin mid-August 2024.

Commenting on the selection of U.S. trial sites, CLEO Chief Executive, Richard Allman, said:

“This marks the first visible activity by CLEO in the U.S. and effectively a large step in the įourney there to bring our ovarian cancer diagnostic blood test to the largest diagnostic market in the world.

We believe that we have a sound strategy and plan that has been supported by the FDA and IRB, and we now move to progress our clinical trials that will ultimately drive our market entry.

I look forward to announcing the start of trial activities in the coming weeks.”

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