Oxygen Biotherapeutics停止外伤性脑损伤药物Oxycyte的IIb期临床试验

Oxygen Biotherapeutics停止外伤性脑损伤药物Oxycyte的IIb期临床试验

                               
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                                        发布日期：2014-09-22  来源：pipelinereview  
Oxygen Biotherapeutics近日已决定停止正在进行中的Oxycyte的IIb期临床试验，Oxycyte是一种用于治疗外伤性脑损伤的药物。

                               
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     Oxygen Biotherapeutics近日已决定停止正在进行中的Oxycyte的IIb期临床试验，Oxycyte是一种用于治疗外伤性脑损伤的药物。IIb期临床试验本用来评估Oxycyte对严重的非穿透性创伤性脑损伤（severe non-penetrating traumatic brain injury，STOP-TBI）患者的安全性和耐受性。决定停止该试验是由该公司董事会一致同意后批准的。Oxycyte 是一种专有的全氟化碳（perfluorocarbon，PFC）携氧治疗剂，Oxygen公司将审查自Oxycyte临床试验开始招募患者之日起所产生的全部试验数据。
Oxygen公司董事会主席Ronald Blanck讲到，“鉴于在招募Oxycyte IIb期临床试验患者方面的困难程度，Oxygen董事会和管理团队一致认为在一段合理的时间内完成这项试验是不可行的。”
目前公司已完成了针对Oxycyte静脉注射给药方式下创伤性脑损伤、减压病和中风等适应症的相关临床和临床前评价。
接下来Oxygen公司将集中资源在其领导性关键产品——左西孟旦（levosimendan，左西孟坦）的研究上，左西孟旦是一种用于降低心脏手术患者发生低心排综合征（LCOS）发病率和致死率风险的钙增敏剂，Oxygen公司对左西孟旦在美国的III期临床阶段于今年7月刚刚展开。而目前左西孟旦被开发以静脉注射的方式治疗住院患者的急性失代偿性心脏衰竭。
Oxygen Biotherapeutics Announces Halt of Oxycyte Phase IIb Traumatic Brain Injury Trial

Oxygen Biotherapeutics, Inc. (NASDAQ: OXBT), a specialty pharmaceutical company focused on developing and commercializing a portfolio of products for the critical care market, today announced that the Company, with unanimous approval from the Board of Directors, has elected to stop the current Phase IIb trial for its Oxycyte drug candidate and consider strategic alternatives for the program moving forward. The company will review the data generated on the patients enrolled in the trial to date.
“With the difficulties we have had enrolling patients at the current Phase IIb clinical sites for Oxycyte, the Oxygen Board of Directors and management team has decided that completing this trial in a reasonable period of time is not feasible,” said Dr. Ronald Blanck, Chairman of the Oxygen Board of Directors. "We will be considering strategic alternatives for Oxycyte moving forward.”
Oxycyte, a proprietary perfluorocarbon (PFC) therapeutic oxygen carrier, was in clinical and preclinical studies for intravenous delivery in indications such as traumatic brain injury, decompression sickness and stroke. The current Phase IIb study was evaluating the safety and tolerability of Oxycyte in patients with severe non-penetrating traumatic brain injury (STOP-TBI).
The Company will be focusing resources on its lead critical care product, levosimendan, a calcium sensitizer in Phase 3 development in the United States for the reduction of morbidity and mortality in cardiac surgery patients at risk for developing Low Cardiac Output Syndrome (LCOS).
In July 2014, Oxygen initiated a Phase 3 trial in the United States to evaluate levosimendan in cardiac surgery patients at risk of developing LCOS. The FDA has granted Fast Track status for levosimendan in this indication.
about Oxygen Biotherapeutics
Oxygen Biotherapeutics, Inc. is a specialty pharmaceutical company focused on developing and commercializing a portfolio of products for the critical care market. The company acquired the North American rights to develop and commercialize levosimendan, and the United States Food and Drug Administration (FDA) has granted Fast Track status for levosimendan for the reduction of morbidity and mortality in cardiac surgery patients at risk for developing Low Cardiac Output Syndrome (LCOS). The company initiated a Phase 3 trial with levosimendan in that indication in July 2014.
about Levosimendan
Levosimendan is a calcium sensitizer developed for intravenous use in hospitalized patients with acutely decompensated heart failure. It was discovered and developed by Orion Pharma, Orion Corporation of Espoo Finland, and is currently approved in over 50 countries for this indication and not available in the United States. Oxygen Biotherapeutics acquired the North American rights to develop and commercialize levosimendan from Phyxius Pharma. The United States Food and Drug Administration (FDA) has granted Fast Track status for levosimendan for the reduction of morbidity and mortality in cardiac surgery patients at risk for developing Low Cardiac Output Syndrome (LCOS). In addition, the FDA has agreed to the Phase 3 protocol design under Special Protocol Assessment (SPA), and provided guidance that a single successful trial will be sufficient to support approval of levosimendan in this indication.

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