BrainStorm Cell Therapeutics is mapping out the path forward for its experimental amyotrophic lateral sclerosis (ALS) therapy, and while those plans include a new Phase 3 clinical trial the biotech is slimming down its operations in order to pay for it.

BrainStorm Cell Therapeutics正在为其实验性肌萎缩侧索硬化症（ALS）治疗开辟道路，虽然这些计划包括一项新的3期临床试验，但生物技术正在缩减其运营以支付费用。

About 30% of BrainStorm’s staff will be laid off, the New York-based biotech company said Tuesday. The company’s most recent financial report issued in August lists 44 employees in the U.S. and Israel. The company expects to complete the job cuts by the end of this year.

纽约生物技术公司星期二表示，大约30%的BrainStorm员工将被解雇。该公司8月份发布的最新财务报告列出了美国和以色列的44名员工。公司预计在今年年底前完成减职工作。

The corporate shakeup comes nearly a month after an FDA advisory committee voted against backing NurOwn, BrainStorm’s stem cell therapy for ALS. In explaining their votes, committee member expressed concerns that ranged from uncertainty about the efficacy of the therapy as well as questions about its safety.

在FDA咨询委员会投票反对支持护理，BrainStorm的干细胞治疗ALS近一个月后，该公司的摇动就出现了。在解释他们的投票时，委员会成员表达了各种担忧，包括对治疗效果的不确定性以及对其安全性的质疑。

BrainStorm had pointed to benefit in a subgroup of patients, but FDA staffers and some committee members said these findings by themselves were insufficient to support regulatory approval and would need to be explored further in another clinical trial..

BrainStorm指出在一小组患者中受益，但FDA工作人员和一些委员会成员表示，这些发现本身不足以支持监管部门的批准，需要在另一项临床试验中进一步探讨。。

The FDA was expected to issue a regulatory decision for NurOwn in early December, but BrainStorm last week withdrew the application with understanding from the FDA that the company could try again. BrainStorm is now providing some detail about those plans. The company is preparing for a double-blind, placebo-controlled Phase 3b study in the U.S., followed by an open-label extension study.

预计FDA将于12月初发布护理监管决定，但BrainStorm上周在FDA了解该公司可以再次尝试的情况下撤回了该申请。BrainStorm现在提供有关这些计划的一些细节。该公司正在美国准备进行一项双盲，安慰剂对照的3b期研究，随后进行开放标签扩展研究。

BrainStorm said it will continue to publish NurOwn data about biomarkers, long-term safety and survival, and the expanded access program that provides patients with an experimental therapy outside of the context of a clinical trial. In addition to preparing for the trial design and subsequent FDA meeting, BrainStorm said it is consulting with NurOwn principal investigators, an additional panel of independent ALS experts, and a patient advisory group..

BrainStorm表示，它将继续发布有关生物标志物，长期安全性和生存率的护理数据，以及为患者提供临床试验背景之外的实验性治疗的扩展获取计划。除了为试验设计和随后的FDA会议做准备外，BrainStorm还表示正在与NurOwn首席调查员，一个额外的独立ALS专家小组和一个患者咨询小组进行咨询。。

Financing the new clinical trial will be challenging. BrainStorm’s last financial report shows a cash position of just $748,000. In addition cutting its expenses, the company said it is exploring options to raise money that include non-dilutive grant funding and capitalizing on its technology for manufacturing exosomes from mesenchymal stem cells..

为新的临床试验提供资金将具有挑战性。BrainStorm的最后一份财务报告显示现金状况仅为748000美元。除了削减费用外，该公司还表示正在探索筹集资金的选择，包括非稀释拨款资金，并利用其技术从间充质干细胞制造外泌体。。

The layoffs will focus on cutting positions not critical to the Phase 3b study and a new FDA submission. Among those losing a job is Kirk Taylor, executive vice president and chief medical officer. BrainStorm said Taylor’s role largely focused on global medical affairs and launch activities for NurOwn.

停工将集中在削减对3b期研究并不重要的职位和FDA提交的新文件。其中失业的是执行副总裁兼首席医疗官Kirk Taylor。BrainStorm表示，泰勒的角色主要集中在全球医疗事务上，并为托儿所开展活动。

With commercialization no longer imminent, Taylor’s role and others were eliminated. In a securities filing, BrainStorm said it expects the layoffs will lead to costs and expenses ranging between $450,000 and $900,000, mainly for severance and one-time termination benefits..

随着商业化不再迫在眉睫，泰勒的角色和其他人被淘汰。在证券申报中，BrainStorm表示，预计停工将导致成本和费用在45万美元至90万美元之间，主要用于离职和一次性终止福利。。

“We remain steadfast in our goal to make NurOwn available to the ALS community as quickly as possible, and we believe that this strategic realignment offers our best chance for success,” BrainStorm President and CEO Chaim Lebovits said in a prepared statement. “While remaining open to partnership opportunities that could accelerate growth, the steps we are taking now reflect our unwavering commitment to those battling this horrific disease and our firm belief in the potential value of NurOwn.”.

BrainStorm总裁兼首席执行官Chaim Lebovits在准备好的声明中说：“我们的目标是尽快为ALS社区提供托儿所，我们相信这种战略调整为我们提供了最大的成功机会。”。“在保持开放伙伴关系机会以加速增长的同时，我们现在采取的步骤反映了我们对那些与这种可怕疾病作斗争的人的坚定承诺，以及我们对护理的潜在价值的坚定信念。”。

Photo: Kerrick, Getty Images

照片：Kerrick，Getty图片

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