{"id":3050,"date":"2024-04-12T00:06:38","date_gmt":"2024-04-12T00:06:38","guid":{"rendered":"https:\/\/businesstriumphs.com\/index.php\/2024\/04\/12\/cleo-appoints-cro-to-manage-u-s-ovarian-cancer-clinical-trials\/"},"modified":"2024-04-12T00:06:38","modified_gmt":"2024-04-12T00:06:38","slug":"cleo-appoints-cro-to-manage-u-s-ovarian-cancer-clinical-trials","status":"publish","type":"post","link":"https:\/\/businesstriumphs.com\/index.php\/2024\/04\/12\/cleo-appoints-cro-to-manage-u-s-ovarian-cancer-clinical-trials\/","title":{"rendered":"CLEO Appoints CRO to Manage U.S. Ovarian Cancer Clinical Trials"},"content":{"rendered":"

Ovarian cancer diagnostics company, Cleo Diagnostics Limited<\/strong> (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. <\/p>\n

Highlights<\/strong><\/p>\n

CLEO has appointed U.S.-based Lindus Health to manage U.S. clinical trials for its revolutionary ovarian cancer blood testLindus Health is a leader in clinical trial management for the med-tech sector, with a strong record of timely and successful trial executionCLEO\u2019s U.S. study will prospectively recruit up to 500 patients commencing next month and will verify the performance of CLEO\u2019s pre-surgical ovarian cancer test for FDA regulatory approval. <\/p>\n

U.S. Ovarian Cancer Clinical Trials
<\/strong><\/div>\n

As a part of CLEO\u2019s 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\u2019s objectives.<\/p>\n

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.<\/p>\n

Comprehensive U.S. patient data is essential for a successful regulatory application through the Food and Drug Administration (FDA). CLEO will leverage Lindus Health\u2019s expertise to execute a cost-effective and rapid clinical study that will support its subsequent FDA 510(k) application.<\/p>\n

The study will benchmark CLEO\u2019s 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. <\/p>\n

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. <\/p>\n

The study data will be published in the mainstream medical literature as a part of CLEO\u2019s rigorous publication strategy. <\/p>\n

Commenting on the partnership with Lindus Health, CLEO Chief Executive, Richard Allman, said:<\/strong><\/p>\n

\u201cWith the appointment of Lindus Health, our U.S. market access program is well underway to achieve our goal of obtaining regulatory approval for CLEO\u2019s initial pre-surgical market in the U.S. for our ovarian cancer blood test.<\/em><\/p>\n

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.\u201d <\/em><\/em><\/p>\n<\/p>\n

Click here for the full ASX Release<\/strong><\/p>\n<\/p>\n

This post appeared first on investingnews.com<\/div>\n","protected":false},"excerpt":{"rendered":"

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. Highlights CLEO has appointed U.S.-based Lindus Health to manage U.S. clinical trials for its revolutionary ovarian cancer blood testLindus […]<\/p>\n","protected":false},"author":0,"featured_media":3051,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-3050","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-investing"],"_links":{"self":[{"href":"https:\/\/businesstriumphs.com\/index.php\/wp-json\/wp\/v2\/posts\/3050","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/businesstriumphs.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/businesstriumphs.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"replies":[{"embeddable":true,"href":"https:\/\/businesstriumphs.com\/index.php\/wp-json\/wp\/v2\/comments?post=3050"}],"version-history":[{"count":0,"href":"https:\/\/businesstriumphs.com\/index.php\/wp-json\/wp\/v2\/posts\/3050\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/businesstriumphs.com\/index.php\/wp-json\/wp\/v2\/media\/3051"}],"wp:attachment":[{"href":"https:\/\/businesstriumphs.com\/index.php\/wp-json\/wp\/v2\/media?parent=3050"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/businesstriumphs.com\/index.php\/wp-json\/wp\/v2\/categories?post=3050"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/businesstriumphs.com\/index.php\/wp-json\/wp\/v2\/tags?post=3050"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}