BioCardia’s dive into its paused phase 3 heart failure trial has failed to identify reasons to be optimistic about the primary endpoint. Weeks after the monitoring board recommended pumping the brakes, the biotech has revealed the study is unlikely to meet its main objective, putting another dent in its share price..

BioCardia进入暂停的3期心力衰竭试验未能确定对主要终点持乐观态度的原因。在监测委员会建议刹车几周后，生物技术公司发现这项研究不太可能达到其主要目标，从而降低了其房价。。

News that the phase 3 trial was in trouble emerged in late July, when BioCardia told investors that the independent data safety monitoring board had recommended pausing enrollment pending the analysis of patients that were then completing one-year follow-up. BioCardia has now seen results from the 102 randomized patients who have completed their one-year review—and the news is bad..

7月下旬，Biocardi告诉投资者，独立数据安全监测委员会建议在分析完成一年随访的患者之前暂停注册。BioCardia现在已经看到102名随机完成一年评估的患者的结果，消息很糟糕。。

The primary endpoint is a composite measure with three elements. On the first element—all-cause death including cardiac death equivalents such as heart transplant or left ventricular assist device placement—BioCardia’s cell therapy CardiAMP was no better than the control. Specifically, the rate of all-cause death and cardiac death equivalents after one year was 5.6% in the CardiAMP cohort and 5.3% in the control group..

主要终点是具有三个元素的综合度量。第一个因素是全因死亡，包括心脏死亡当量，如心脏移植或左心室辅助装置放置BioCardia的细胞疗法CardiAMP并不比对照组好。具体而言，CardiAMP队列中一年后全因死亡率和心源性死亡率相当于5.6%，对照组为5.3%。。

CardiAMP fared no better on the other two elements. The rate of nonfatal major adverse cardiac events was similar in the two cohorts, with 16.7% in the treatment group versus 15.8% in the control, and BioCardia saw no significant difference in the change in six-minute walk test distance.

CardiAMP在其他两个方面表现不佳。两组患者的非致命性主要不良心脏事件发生率相似，治疗组为16.7%，对照组为15.8%，BioCardia在6分钟步行试验距离的变化中无显着差异。

CardiAMP involves delivering a patient’s bone marrow cells to the heart via a catheter-based procedure with the hope of stimulating the body’s natural healing response. The failure of the therapy to significantly improve outcomes on any aspect of the composite endpoint in the phase 3 trial led BioCardia to conclude that the study is unlikely to succeed.

CardiAMP涉及通过基于导管的程序将患者的骨髓细胞递送至心脏，希望刺激身体的自然愈合反应。在3期试验中，治疗未能显着改善复合终点任何方面的结果，导致BioCardia得出结论，该研究不太可能成功。

Study sites are completing the treatment of patients previously enrolled in the trial, and BioCardia will continue to follow the participants..

研究地点正在完成先前参加试验的患者的治疗，BioCardia将继续跟踪参与者。。

The company’s analysis of all available follow-up in the patients tracked up to 24 months contains glimpses of possible efficacy. The rate of all-cause death and cardiac death equivalents was lower in the CardiAMP cohort, 8.3%, than the control arm, 13.2%. BioCardia also linked CardiAMP to a numerical improvement, 16.7% versus 23.6%, in nonfatal major adverse cardiac events..

该公司对追踪至24个月的患者的所有可用随访分析包含可能的疗效一瞥。CardiAMP队列中全因死亡率和心源性死亡率相当于对照组的8.3%，低于对照组的13.2%.BioCardia还将CardiAMP与非致命性主要不良心脏事件的数值改善联系起来，分别为16.7%和23.6%。。

“We are actively engaged in identifying patients who responded the most to the therapy and are considering other learnings with respect to trial design to inform this program and our other two ongoing clinical programs,” Peter Altman, Ph.D., BioCardia’s president and CEO, said in a statement. “We anticipate working with the principal investigators and executive steering committee on these efforts.”.

BioCardia总裁兼首席执行官Peter Altman博士说：“我们积极参与确定对治疗反应最大的患者，并正在考虑试验设计方面的其他学习，以便为该计划和我们其他两个正在进行的临床计划提供信息。”在一份声明中。“我们预计将就这些努力与主要调查人员和执行指导委员会合作。”。

Investor expectations are low. The latest update sent BioCardia’s stock down around 20% to 62 cents in premarket trading, adding to losses that have seen the share price slide by more than 60% in six months.

投资者的期望很低。最新更新发布了BioCardia在上市前交易中将股票下跌约20%至62美分，增加了六个月内房价下跌超过60%的损失。