{"id":227,"date":"2010-07-22T11:10:12","date_gmt":"2010-07-22T15:10:12","guid":{"rendered":"http:\/\/sciencebusiness.technewslit.com\/?p=227"},"modified":"2010-07-22T11:10:12","modified_gmt":"2010-07-22T15:10:12","slug":"acute-radiation-syndrome-drug-granted-fda-fast-track-status","status":"publish","type":"post","link":"https:\/\/technewslit.com\/sciencebusiness\/?p=227","title":{"rendered":"Acute Radiation Syndrome Drug Granted FDA Fast Track Status"},"content":{"rendered":"<p><a href=\"http:\/\/www.cbiolabs.com\/\">Cleveland BioLabs Inc.<\/a>, a biotechnology company in Buffalo, New York, today announced that CBLB502, a drug developed for the treatment of acute radiation syndrome (ARS), has been granted fast track status by the U.S. Food and Drug Administration (FDA).<\/p>\n<p>CBLB502 is derived from a microbial protein that can reduce injury from acute stresses, such as radiation and chemotherapy, by mobilizing several natural cell protective mechanisms. FDA&#8217;s fast track program expedites the review of investigational drugs for the treatment of patients with serious or life-threatening diseases where there is an unmet medical need.<\/p>\n<p>The company says CBLB502 is being developed under the FDA&#8217;s Animal Efficacy Rule to treat ARS or radiation poisoning from any exposure to radiation such as a nuclear or radiological weapon (e.g., &#8220;dirty bomb&#8221;), or from a nuclear accident. This approval pathway requires demonstration of efficacy in representative animal models and safety, and various testing protocols in healthy human volunteers.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Cleveland BioLabs Inc., a biotechnology company in Buffalo, New York, today announced that CBLB502, a drug developed for the treatment of acute radiation syndrome (ARS), has been granted fast track status by the U.S. Food and Drug Administration (FDA). CBLB502 is derived from a microbial protein that can reduce injury from acute stresses, such as [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[15,5],"tags":[21,22],"class_list":["post-227","post","type-post","status-publish","format-standard","hentry","category-products","category-regulations","tag-biotech","tag-fda"],"_links":{"self":[{"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=\/wp\/v2\/posts\/227","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=227"}],"version-history":[{"count":3,"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=\/wp\/v2\/posts\/227\/revisions"}],"predecessor-version":[{"id":230,"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=\/wp\/v2\/posts\/227\/revisions\/230"}],"wp:attachment":[{"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=227"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=227"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=227"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}