朱诺治疗（JUNO）的CAR-T方案已经放置在临床保留

StephenW

Feuerstein: Juno Patient Deaths Crash Cancer-Killing CAR-T Party
The lead CAR-T program of Juno Therapeutics has been placed on a clinical hold by U.S. regulators following the deaths of two patients in a pivotal clinical trial.
Adam Feuerstein
Follow Jul 7, 2016 4:54 PM EDT

The lead CAR-T program of Juno Therapeutics (JUNO) has been placed on a clinical hold by U.S. regulators following the deaths of two patients in a pivotal clinical trial.

Juno shares are down 29% to $29.01. Shares of Kite Pharma (KITE) , Ziopharm (ZIOP) and Bluebird Bio (BLUE) -- competitors developing their cancer-killing CAR-T therapies -- are all trading lower.

CAR-T, or chimeric antigen receptor T-cells, is a new form of cancer immunotherapy in which a patient's own T cells are removed and then engineered to identify and kill malignant blood cancer cells.

The U.S. Food and Drug Administration ordered a clinical hold after two leukemia patients died from cerebral edema following treatment with Juno's product JCAR015 in a phase II clinical trial. A third patient in the same study died earlier this year, also from cerebral edema.

Juno believes the deaths were caused by the use of the chemotherapy agent fludarabine interacting with JCAR015. Fludarabine is used to clear out a patient's old T cells in order for the re-engineered T cells in the CAR-T to grow and take hold.
The company intends to quickly submit paperwork to the FDA to amend its study so that fludarabine is no longer used. Juno hopes the FDA concerns are satisfied and the clinical hold can be lifted but there are not guarantees. Previous guidance from Juno that JCAR015 could be approved in 2017 is now off the table.
Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

StephenW

斯坦：朱诺患者死亡崩溃杀癌CAR-T党
下面的两个病人处于举足轻重的临床试验死亡朱诺治疗的铅CAR-T方案已经放置在临床拿住美国监管机构。
亚当·福伊尔施泰因
按照2016年7月7日下午4时54 EDT
朱诺治疗（JUNO）的CAR-T方案已经放置在临床保留
下面的两个病人处于举足轻重的临床试验死亡朱诺治疗（JUNO）的铅CAR-T方案已经放置在临床拿住美国监管机构。

朱诺股价下跌了29％至$ 29.01。发展自己的杀癌CAR-T治疗的竞争对手 - - 风筝制药（KITE），ZIOPHARM（ZIOP）和蓝鸟生物（蓝色）的股票均走低。

CAR-T，或嵌合抗原受体的T细胞，是癌症免疫疗法的一种新形式，其中患者自身的T细胞被除去，然后设计来识别和杀死恶性血液癌细胞。

美国食品和药物管理局下令暂停临床经过两次白血病患者患脑水肿与Juno的产品JCAR015治疗的II期临床试验死亡。在同一研究中的第三个病人在今年早些时候去世，也是从脑水肿。

朱诺认为死亡是由使用化疗剂氟达拉滨与JCAR015相互作用引起的。氟达拉滨用于清除出去，以便重新设计的T细胞中的CAR-T成长，扎根病人的旧T细胞。
该公司打算很快递交文书向FDA修订其研究，使氟达拉滨不再使用。朱诺希望FDA关注的是满意和临床保持可以解除，但有没有保证。从朱诺的JCAR015可能在2017年得到批准之前的指导，现在是假表。
亚当斯坦定期为TheStreet写道。在与公司的编辑政策一致，他并不拥有或短的个股，虽然他拥有的股票TheStreet。他也不会投资于对冲基金或其他私人投资伙伴关系。斯坦感谢您的反馈;点击这里给他的电子邮件。