CLEO Appoints CRO to Manage U.S. Ovarian Cancer Clinical Trials

MELBOURNE, AUSTRALIA, 11 April 2024: Ovarian cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) (CLEO, or the Company) is pleased to announce the appointment of international Contract Research Organization (CRO), Lindus Health, as a key partner for its U.S. clinical trials program.

U.S. Ovarian Cancer Clinical Trials

As a part of CLEO’s U.S. market access program, the Company will partner with U.S.-based CRO, Lindus Health, appointing it to manage the successful execution of its ovarian cancer U.S. clinical trials. Lindus Health was chosen following a robust process to identify a partner with the proven experience, technology and high standards capable of delivering on CLEO’s objectives.

Lindus Health specialises in collaborating with med-tech companies to conduct clinical trials worldwide, leveraging their innovative patient recruitment and trial management technology platform to deliver efficient and timely outcomes.

Comprehensive U.S. patient data is essential for a successful regulatory application through the Food and Drug Administration (FDA). CLEO will leverage Lindus Health’s expertise to execute a cost-effective and rapid clinical study that will support its subsequent FDA 510(k) application.

The study will benchmark CLEO’s pre-surgical ovarian cancer triage test and provide the core data requirements for the FDA 510(k) application. Up to 500 U.S.-based patients will be recruited, with the trial scheduled over 10 months following ethic approvals and site engagement.

An Australian arm of the trial will also run concurrently and be managed directly by CLEO. This dual-arm strategy mitigates risk to the timelines due to patient recruitment, and will provide additional patient samples for kit verification following manufacture.

The study data will be published in the mainstream medical literature as a part of CLEO’s rigorous publication strategy.

Commenting on the partnership with Lindus Health, CLEO Chief Executive, Richard Allman, said:

“With the appointment of Lindus Health, our U.S. market access program is well underway to achieve our goal of obtaining regulatory approval for CLEO’s initial pre-surgical market in the U.S. for our ovarian cancer blood test. CLEO is appointing high calibre partners that we believe will help us deliver our important ovarian cancer detection technology to improve the health outcomes for women.”

About Lindus Health

Lindus Health is an anti-CRO running radically faster and more reliable trials for life science pioneers – bringing ground-breaking treatments to patients more quickly. This is achieved  through a commercial model that aligns incentives (fixed-priced quotes per study, with milestone-based payments), a world-class clinical operations team with its unique software platform, and access to over 30 million Electronic Health Records. 

Clinical trials are the biggest bottleneck to advances in healthcare. Lindus Health removes this constraint by handling the end-to-end execution of clinical studies, including design, patient recruitment, clinical data capture, monitoring and project management.

To date, Lindus Health has delivered more than 90 trials across the US, UK and Europe to tackle a range of conditions, including diabetes, asthma, acne, social anxiety, major depressive disorder, hypertension, chronic fatigue syndrome and insomnia. The company has raised over $24M from investors including Peter Thiel, CREANDUM, Firstminute Capital, Presight Capital, Seedcamp, Hambro Perks, Amino Collective and Calm/Storm.

About Cleo Diagnostics Ltd

CLEO aims to bring to market a simple blood test for the accurate and early diagnosis of ovarian cancer based on the novel patented CXCL10 biomarker, which is produced early and at high levels by ovarian cancers but is largely absent in nonmalignant disease. The test aims to distinguish benign from malignant growths in a standard format that will be readily compatible with existing equipment used by diagnostic laboratories worldwide.

The platform is backed by over 10 years of scientific Research & Development at the Hudson Institute of Medical Research, with two clinical studies conducted with over 500 patients. Pursuant to a licence agreement with the Hudson Institute ofMedical Research, CLEO has a worldwide exclusive licence to commercialise the intellectual property which underpins its operations and the ovarian cancer tests.

The clinical unmet worldwide need is urgent. An accurate and early detection blood test could shift survivability for ovarian cancer significantly as seen with other cancers. CLEO is advancing the availability of its simple blood test, under a modularexecution strategy which is designed to eventually address all ovarian cancer detection markets with specific tests includingsurgical triage, recurrence, high risk, and early-stage screening.