Cellerant获得4750万美元用于支持CLT-008随机II期临床试验

Cellerant获得4750万美元用于支持CLT-008随机II期临床试验

                               
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                                       发布日期：2014-09-22  来源：pharmaceutical-business-review  
美国生物技术公司Cellerant Therapeutics近日获得美国生物医学高级研究开发局(The Biomedical Advanced Research and Development Authority，BARDA)在相关权利框架下的4750万美元合同付款，用于对CLT-008进行更深一步的研究，此次付款是总价为1.638亿美元的合同付款的一部分。

                               
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CLT-008是第一个治疗急性辐射综合征（ARS）造血亚综合征的异源细胞疗法药物。此次付与的款项将用于Cellerant公司针对CLT-008在急性髓系白血病（AML）患者中展开的随机II期临床试验，以及获得治疗ARS批准所需的非临床研究。
如果获得FDA的批准，美国联邦政府就可通过生物盾牌计划(Project BioShield)为国家战略储备（Strategic National Stockpile）项目购买CLT-008，生物盾牌计划是一个旨在为国家战略储备加快有效医疗措施的研发、购买和可用性的计划。
Cellerant公司总裁兼首席执行官Ram Mandalam讲到，“公司对联邦政府继续支持Cellerant与BARDA之间这种成功的公-私合作关系而感到高兴。目前对化疗或辐射引起的严重中性粒细胞减少症中所出现的感染相关并发症的医疗需求还未被满足，此次注资正体现了对这一严重问题的重视。
可以利用这些资金开展并完成建立在门诊所观察到的有效数据基础上的AML随机2期临床试验。我们期待着继续与BARDA共同推进CLT-008的研发直至被批准。”
Cellerant gets $47.5m contract to support development of CLT-008
US-based biotechnology firm Cellerant Therapeutics has received $47.5m contract under a second option exercised by the Biomedical Advanced Research and Development Authority (BARDA) to support the continued advanced development of CLT-008.

CLT-008 is a first-in-class, allogeneic, cell-based therapy to treat hematopoietic sub-syndrome of Acute Radiation Syndrome (ARS).
The recent funding is in addition to the $116.4m committed under the two-year base period and the first option, and is part of the total obligated contract valued at $163.8m.
The funding will be used for the company's randomized Phase II clinical trial in patients with acute myeloid leukemia (AML), and the nonclinical studies required for approval in treating ARS.
If licensed by the FDA, the federal government could buy CLT-008 for the Strategic National Stockpile under Project Bioshield, which is designed to accelerate the research, development, purchase and availability of effective medical countermeasures for the Strategic National Stockpile.
Cellerant Therapeutics president and chief executive officer Ram Mandalam said the company is happy that the federal government continues to support its efforts in this successful public-private partnership with BARDA.
"The exercise of this second option reflects recognition of the importance of this first-in-kind therapy to serve an unmet medical need to reduce the infection-related complications from severe neutropenia caused by chemotherapy or exposure to radiation," Mandalam said.
"These funds allow for the initiation and completion of a randomized Phase 2 trial in AML by building on efficacy signals observed to date in the clinic. We look forward to continuing to work with BARDA to advance CLT-008 development towards approval."

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