{"id":8967,"date":"2016-07-12T17:33:54","date_gmt":"2016-07-12T17:33:54","guid":{"rendered":"http:\/\/www.kurzweilai.net\/?p=284663"},"modified":"2016-07-14T07:29:39","modified_gmt":"2016-07-14T07:29:39","slug":"fda-places-hold-on-clinical-trial-of-cancer-treatment-previously-reported-on-kurzweilai","status":"publish","type":"post","link":"https:\/\/hoo.central12.com\/fugic\/2016\/07\/12\/fda-places-hold-on-clinical-trial-of-cancer-treatment-previously-reported-on-kurzweilai\/","title":{"rendered":"FDA places hold on clinical trial of cancer treatment previously reported on KurzweilAI &mdash; UPDATE: FDA releases hold"},"content":{"rendered":"<p>Juno Therapeutics, Inc. announced July 7 that it has received notice from the FDA that it has placed a clinical hold on an immune-cell cancer treatment known as the \u201cROCKET\u201d trial, which was <a href=\"http:\/\/www.kurzweilai.net\/dramatic-remissions-in-blood-cancer-in-immunotherapy-treatment-trial\" >reported on KurzweilAI<\/a> on Mar. 10, 2016.<\/p>\n<p>The clinical hold was initiated after two patient deaths, which followed the recent addition of fludarabine to the pre-conditioning regimen. Juno has proposed to the FDA to continue the ROCKET trial using JCAR015 with cyclophosphamide pre-conditioning alone.<\/p>\n<p>Further information on <em><a href=\"http:\/\/www.forbes.com\/sites\/matthewherper\/2016\/07\/07\/juno-therapeutics-stops-trial-of-cancer-killing-cells-after-3-patient-deaths\/#682e9b115d89\" >Forbes<\/a><\/em>.<\/p>\n<p>UPDATE JULY 13, 2016: Juno Therapeutics <a href=\"http:\/\/www.businesswire.com\/news\/home\/20160712006692\/en\/Juno-Therapeutics-Resume-JCAR015-Phase-II-ROCKET\" >announced<\/a> Tuesday July 12 that the FDA has removed the hold and &#8220;the ROCKET trial will continue enrollment using JCAR015 with cyclophosphamide pre-conditioning only.&#8221; In related news, the Law Offices of Howard G. Smith\u00a0<a href=\"http:\/\/www.businesswire.com\/news\/home\/20160713006379\/en\/INVESTOR-ALERT-Investigation-Juno-Therapeutics-Announced-Law\" >announced<\/a> an investigation on behalf of investors of Juno Therapeutics, Inc. (NASDAQ:\u00a0<a href=\"http:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Ffinance.yahoo.com%2Fq%3Fuhb%3Duh3_finance_vert%26fr%3D%26type%3D2button%26s%3DJUNO&amp;esheet=51380783&amp;newsitemid=20160713006379&amp;lan=en-US&amp;anchor=JUNO&amp;index=1&amp;md5=1106210f269c83f403c8a31876f40be4\" rel=\"nofollow\" >JUNO<\/a>) concerning the Company and its officers\u2019 possible violations of federal securities laws and noted that &#8220;Juno&#8217;s share price fell significantly in value, dropping almost 32%.&#8221;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Juno Therapeutics, Inc. announced July 7 that it has received notice from the FDA that it has placed a clinical hold on an immune-cell cancer treatment known as the &ldquo;ROCKET&rdquo; trial, which was reported on KurzweilAI on Mar. 10, 2016. The clinical hold was initiated after two patient deaths, which followed the recent addition of [&#8230;]<\/p>\n","protected":false},"author":13,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[42,43],"tags":[],"class_list":["post-8967","post","type-post","status-publish","format-standard","hentry","category-biotech","category-news"],"_links":{"self":[{"href":"https:\/\/hoo.central12.com\/fugic\/wp-json\/wp\/v2\/posts\/8967"}],"collection":[{"href":"https:\/\/hoo.central12.com\/fugic\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/hoo.central12.com\/fugic\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/hoo.central12.com\/fugic\/wp-json\/wp\/v2\/users\/13"}],"replies":[{"embeddable":true,"href":"https:\/\/hoo.central12.com\/fugic\/wp-json\/wp\/v2\/comments?post=8967"}],"version-history":[{"count":3,"href":"https:\/\/hoo.central12.com\/fugic\/wp-json\/wp\/v2\/posts\/8967\/revisions"}],"predecessor-version":[{"id":9041,"href":"https:\/\/hoo.central12.com\/fugic\/wp-json\/wp\/v2\/posts\/8967\/revisions\/9041"}],"wp:attachment":[{"href":"https:\/\/hoo.central12.com\/fugic\/wp-json\/wp\/v2\/media?parent=8967"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/hoo.central12.com\/fugic\/wp-json\/wp\/v2\/categories?post=8967"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/hoo.central12.com\/fugic\/wp-json\/wp\/v2\/tags?post=8967"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}