KANSAS CITY, Mo., Feb. 29, 2024 /PRNewswire/ -- Today, researchers at Vivacelle Bio, Inc., a pioneering biotechnology company revealed the compelling outcomes of their phase 2a clinical trial of the investigational cardiovascular support fluid, VBI-S, in patients with severe septic shock. This landmark study now published in the Lancet's eClinicalMedicine , showcases the potential of VBI-S in transforming the treatment landscape for refractory hypotension in these critically ill patients..

密苏里州堪萨斯城，2024年2月29日/PRNewswire/--今天，开创性生物技术公司Vivacelle Bio，Inc.的研究人员揭示了他们在严重感染性休克患者中进行的研究性心血管支持液VBI-S的2a期临床试验的令人信服的结果。这项里程碑式的研究现已发表在《柳叶刀》的《临床医学》（eClinicalMedicine）上，展示了VBI-s在改变这些重症患者难治性低血压治疗格局方面的潜力。。

Unlike previous septic shock trials, this study, conducted in collaboration with the University of Missouri- Kansas City School of Medicine, there were no restrictions on the severity or duration of the illness or the cardiorespiratory stability of the enrolled patients. Some patients were unstable when given VBI-S.

与之前的感染性休克试验不同，这项与密苏里大学堪萨斯城医学院合作进行的研究对疾病的严重程度或持续时间或入选患者的心肺稳定性没有限制。一些患者在给予VBI-S时不稳定。

Yet the primary endpoint was achieved in each case. Twenty patients with high doses of vasopressors, multiple organ system failure, and a severely dysregulated response to infection were enrolled in the study..

然而，在每种情况下都实现了主要终点。这项研究招募了20名高剂量血管升压药，多器官系统衰竭和对感染反应严重失调的患者。。

Patients, after failing standard fluids, received intravenous VBI-S, a revolutionary composition of phospholipid nanoparticles that reversibly absorb nitric oxide. The results were astonishing, with VBI-S proving 100% effective in elevating mean blood pressure by 10 mmHg or more. Within just 48 hours of the infusion, there were statistically significant improvements across multiple parameters, including oxygenation, renal function, inflammation, lactic acid levels, prothrombin time, and international normalized ratio.

患者在标准液体失败后，接受静脉注射VBI-S，这是一种革命性的磷脂纳米颗粒组成，可可逆地吸收一氧化氮。结果令人惊讶，VBI-S证明100%有效地将平均血压升高10 mmHg或更高。在输注后48小时内，包括氧合，肾功能，炎症，乳酸水平，凝血酶原时间和国际标准化比率在内的多个参数都有统计学上的显着改善。

Furthermore, the sequential organ failure assessment (SOFA) score, a key indicator of illness severity, showed a notable decrease, signifying improved patient conditions. Remarkably, no serious adverse events were attributed to VBI-S..

此外，顺序器官衰竭评估（SOFA）评分是疾病严重程度的关键指标，显示出显着下降，表明患者状况有所改善。值得注意的是，没有严重的不良事件归因于VBI-S。。

Sepsis, affecting 49 million people worldwide and claiming eleven million lives annually, poses a significant global health challenge. In the United States alone, 357,000 people succumb to sepsis each year. The efficacy and safety demonstrated by VBI-S in reversing hypotension, inflammation, and organ failure in septic shock patients suggest a potential paradigm shift in treating sepsis with its associated high mortality and morbidity..

脓毒症影响全世界4900万人，每年夺去1100万人的生命，对全球健康构成重大挑战。仅在美国，每年就有357000人死于败血症。VBI-S在逆转感染性休克患者低血压，炎症和器官衰竭方面的有效性和安全性表明，治疗败血症及其相关的高死亡率和发病率可能发生范式转变。。

Dr. Cuthbert Simpkins, MD, the Sosland Missouri Endowed Chair in Trauma Services at the University of Missouri Kansas City School of Medicine and Chief Innovation Officer of Vivacelle Bio, Inc. stated, 'This study was initially intended as a pilot to determine the variability of VBI-S effects. We did not expect the convincing results that we obtained.

密苏里大学堪萨斯城医学院创伤服务Sosland Missouri捐赠主席兼Vivacelle Bio，Inc.首席创新官Cuthbert Simpkins博士表示，“这项研究最初是为了确定VBI-S效应的可变性。我们没有预料到我们取得的令人信服的结果。

These results fuel our optimism that at last we may have an effective and safe intervention for these very sick patients.'.

这些结果使我们乐观地认为，最终我们可能会对这些病情严重的患者进行有效和安全的干预。”。

Harven DeShield, J.D., Ph. D., CEO of Vivacelle Bio, added, 'Ultimately, the availability, affordability, and accessibility of VBI-S would represent a paradigm shift, substantially transforming how septic shock is treated both in the US and globally upon FDA's clearance of VBI-S to be marketed to the public.'.

Vivacelle Bio首席执行官Harven DeShield博士补充道，“最终，VBI-S的可用性，可负担性和可及性将代表一种范式转变，在FDA批准向公众销售VBI-S后，大大改变美国和全球感染性休克的治疗方式。”。

In a statement, Rod Cotton, 2Flo Ventures Advisory Board Member said, 'The publication of  these clinical trial results in such a highly regarded peer reviewed journal is evidence of the importance of Vivacelle Bio's technology. This article is the introduction of a new concept of medical intervention that will revolutionize the treatment of sepsis and a broad-spectrum of medical conditions bringing hope to patients and their families.' 2Flo Ventures is a startup studio and venture capital firm, and investor in Vivacelle Bio..

2Flo Ventures咨询委员会成员罗德·科顿（RodCotton）在一份声明中表示，“这些临床试验结果在如此备受推崇的同行评审期刊上发表，证明了维瓦塞勒生物技术的重要性。本文介绍了一种新的医疗干预概念，它将彻底改变脓毒症的治疗方法，并为患者及其家人带来希望2Flo Ventures是一家创业工作室和风险投资公司，也是Vivacelle Bio的投资者。。

This groundbreaking research opens new possibilities for the treatment of septic shock, offering hope and potential survival for millions of patients worldwide. The implications of VBI-S in reshaping the landscape of septic shock treatment are promising, marking a significant step forward in the fight against this life-threatening condition..

这项开创性的研究为感染性休克的治疗开辟了新的可能性，为全球数百万患者提供了希望和潜在的生存机会。VBI-S在重塑感染性休克治疗领域的意义是有希望的，标志着在对抗这种危及生命的疾病方面迈出了重要的一步。。

This work was supported by the Naval Medical Research Command (NMRC) - Naval Advanced Medical Development (NAMD) Program under MTEC award 20-02-NavyMultiTopic-002.

这项工作得到了海军医学研究司令部（NMRC）-海军高级医学发展（NAMD）计划的支持，该计划获得了MTEC奖项20-02-NavyMultiTopic-002。

About MTEC

关于MTEC

The Medical Technology Enterprise Consortium (MTEC) is a 501(c)(3) biomedical technology consortium collaborating under an Other Transaction Agreement (OTA) with the U.S. Army Medical Research and Development Command (USAMRDC) that serves those who serve our nation. For more information about MTEC, visit mtec-sc.org..

医疗技术企业联盟（MTEC）是一个501（c）（3）生物医学技术联盟，根据其他交易协议（OTA）与美国陆军医学研究与发展司令部（USAMRDC）合作，该司令部为服务于我们国家的人服务。有关MTEC的更多信息，请访问MTEC-sc.org。。

About 2Flo Ventures

关于2Flo Ventures

2Flo Ventures is a startup studio and venture capital firm dedicated to accelerating equitable innovation in healthcare. They invest in diverse healthcare entrepreneurs and companies built to close gaps in health outcomes for underserved communities.

2Flo Ventures是一家创业工作室和风险投资公司，致力于加速医疗保健领域的公平创新。他们投资于各种各样的医疗保健企业家和公司，以弥补服务不足社区在健康结果方面的差距。

About Vivacelle BioVivacelle Bio (www.vivacellebio.com) is a life sciences company that utilizes patented phospholipid nanoparticle technology to design products that increase the survivability of critically-ill patients. In addition to VBI-S and VBI-1, Vivacelle Bio has a pipeline of products at various stages of development applicable to a range of health areas including reperfusion injury, organ preservation and transplantation, multiple organ dysfunction syndrome and hyperprocalcitonemia.  Vivacelle Bio has raised approximately $10.9M in seed and Series A1-A3 funding, including from the US Department of Defense, the US National Institutes of Health, and 2Flo Ventures.  .

关于Vivacelle BioVivacelle Bio（www.vivacellebio.com）是一家生命科学公司，利用获得专利的磷脂纳米粒子技术来设计提高危重病人生存能力的产品。除了VBI-S和VBI-1之外，Vivacelle Bio还有一系列处于不同开发阶段的产品，适用于一系列健康领域，包括再灌注损伤、器官保存和移植、多器官功能障碍综合征和高降钙素原血症。Vivacelle Bio已经从美国国防部、美国国立卫生研究院和2Flo Ventures等机构筹集了大约1090万美元的种子和A1-A3系列资金。。

Forward looking statements

前瞻性声明

This press release may contain certain forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, all statements other than statements of historical fact included in this press release about future events are subject to (I) change without notice, (ii) factors beyond the Company's control and (iii) the financial capabilities of the Company.

本新闻稿可能包含某些前瞻性声明。尽管公司认为其预期是基于合理的假设，但本新闻稿中关于未来事件的历史事实声明以外的所有声明都可能会发生以下情况：（I）不经通知而发生变化；（ii）公司无法控制的因素；（iii）公司的财务能力。

These statements may include, without limitation, any statements preceded by, followed by or including words such as 'target,' 'believe,' 'expect,' 'aim,' 'intend,' 'may,' 'anticipate,' 'estimate,' 'plan,' 'project,' 'will,' 'can have,' 'likely,' 'should,' 'would,' 'could' and other words and terms of similar meaning or the negative thereof.

这些陈述可能包括但不限于任何前面、后面或包括“目标”、“相信”、“期望”、“目标”、“打算”、“可能”、“预期”、“估计”、“计划”、“项目”、“意志”、“可能有”、“可能”、“应该”、“会”、“可能”等词语和术语的陈述，以及其他具有类似含义或否定含义的词语和术语。

Forward looking statements are subject to inherent risks and uncertainties beyond the Company's control that could cause the Company's actual results, performance or achievements to be materially different from the expected results, performance or achievements expressed or implied by such forward-looking statements.

前瞻性陈述受到公司无法控制的固有风险和不确定性的影响，这些风险和不确定性可能导致公司的实际业绩、业绩或成就与此类前瞻性陈述所表达或暗示的预期业绩、业绩或成就存在重大差异。

Except as required by law, the Company assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future..

除法律要求外，公司没有义务公开更新这些前瞻性声明，也没有义务更新实际结果可能与前瞻性声明中预期的结果有重大差异的原因，即使将来有新的信息可用。。

SOURCE Vivacelle Bio

来源Vivacele Bio