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CytRx宣布启动aldoxorubicin在二线软组织肉瘤患者中的Ph3期临床试验,将在2016年第四季度对数据进行分析
CytRx Announces Initial Results of Phase 3 Trial of Aldoxorubicin in Patients with Second-Line Soft Tissue Sarcoma; Subsequent Analysis to Be Announced Fourth Quarter 2016CytRx宣布启动aldoxorubicin在二线软组织肉瘤患者中的Ph3期临床试验；将在2016年第四季度对数据进行分析LOS ANGELES,?July 11, 2016?/PRNewswire/ --?CytRx Corporation (NASDAQ:?CYTR), a biopharmaceutical research and development company specializing in oncology, today announced the results of an analysis of its global, randomized, Phase 3 clinical trial of aldoxorubicin compared to investigators choice therapy in patients with relapsed or refractory soft tissue sarcomas (STS).?【CytRx公司今天宣布了aldoxorubicin对比investigators choice治疗在难治性或复发性软组织肉瘤（rrSTS）患者中的Ph3期临床试验结果。】In accordance with the FDA-granted special protocol assessment, the current analysis occurred following 191 progression events.? Because enrollment was interrupted by a partial clinical hold in?November 2014, this analysis did not provide for sufficient follow-up for the nearly two-thirds of patients who entered the Phase 3 study after the hold was resolved and enrollment resumed.? This resulted in nearly half of all patients being censored (excluded) from the current progression free survival (PFS) evaluation.? CytRx expects to conduct a second analysis, which will include longer patient follow-up and allow for greater maturation of all endpoints.? The Company expects to announce the results of this evaluation and hold an end-of-Phase 3 meeting with the Food and Drug Administration (FDA) in the fourth quarter of 2016.? The partial clinical hold was related to a single patient enrolled in a compassionate use study, which was subsequently resolved successfully.?【根据FDA授权的特殊协议评估，目前的分析依据了191例进展事件。由于招募患者工作时在2014年11月出现了一项特殊的临床事件而中断（据查为一例患者死亡），在中断得到解决恢复招募工作后入组的患者，其中近三分之二的患者未有充分的进行随访工作。这导致近半数患者被排除在当前的无进展生存期（PFS）评价中。CytRx希望进行二次分析，将纳入更长期患者的随访过程以及让各终点数据更成熟。公司期望在2016年第四季度公布结果并与FDA开展Ph3期完结会议。先前的特殊临床中断事件与一个病人进行同情使用相关，而后该事件已经成功解决了。】For the current evaluation, the study did not show a significant diffe
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