HOUSTON, June 2, 2020 \/PRNewswire\/ \u2014 Cellenkos Inc.<\/b>, a privately held, clinical stage biotech company announced today that the US Food & Drug Administration (FDA) has cleared the way to initiate a Phase 1 clinical trial of CK0802 (Cryopreserved Cord Blood Derived T-Regulatory Cells) for treatment of COVID-19 associated acute respiratory distress syndrome (ARDS). The trial is designed as a randomized, double-blinded, placebo-controlled study to assess safety and preliminary efficacy in this hospitalized patient population.<\/p>\n
\u201cWe appreciate FDA\u2019s expedited review of our plans to evaluate CK0802 in critically ill, intubated patients suffering from ARDS, a deadly complication of COVID-19\u201d, said Elizabeth J Read, MD, Chief Technology Officer, Cellenkos Inc. \u201cPreliminary observations in two intubated COVID-19 ARDS patients, who received cryopreserved cord blood T-regulatory cells under FDA Emergency Use Authorization after failing tociluzumab, were promising. In the forthcoming Phase 1 randomized trial, CK0802 will be assessed for both toxicity and 28-day treatment success, as co-primary outcomes.\u201d<\/p>\n
\u201cUse of allogeneic, off-the-shelf cord blood-derived T-regulatory cells has emerged as a promising therapeutic strategy for the treatment of inflammatory disorders, specifically in terms of interrupting and arresting the cytokine storm unleashed by COVID-19 infection,\u201d said Dr Siddhartha Mukherjee, MD, PhD, Columbia University, New York, scientific advisor and collaborator on the multi-center clinical trial. \u201cRather than indiscriminate therapy with a drug such as an inhibitor of single cytokine such as IL-6, the T-regulatory cells can potentially calm inflammation exactly where it is most active, without causing a more general \u201cglobal\u201d immunosuppression that would be harmful in a virally infected patient. Planned correlative assays during the clinical trial will provide insights into the mechanism of action of CK0802 and its relation to clinical outcomes.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"
HOUSTON, June 2, 2020 \/PRNewswire\/ \u2014 Cellenkos Inc., a privately held, clinical stage biotech company announced today that the US Food & Drug Administration (FDA) has cleared the way to initiate a Phase 1 clinical trial of CK0802 (Cryopreserved Cord Blood Derived T-Regulatory Cells) for treatment of COVID-19 associated acute respiratory distress syndrome (ARDS). The [\u2026]<\/p>\n","protected":false},"author":575,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[11],"tags":[],"class_list":["post-108207","post","type-post","status-publish","format-standard","hentry","category-biotech-medical"],"_links":{"self":[{"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/posts\/108207","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/users\/575"}],"replies":[{"embeddable":true,"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/comments?post=108207"}],"version-history":[{"count":1,"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/posts\/108207\/revisions"}],"predecessor-version":[{"id":108234,"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/posts\/108207\/revisions\/108234"}],"wp:attachment":[{"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/media?parent=108207"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/categories?post=108207"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/tags?post=108207"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}