LOS ALTOS, Calif.--(BUSINESS WIRE)--RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, today announced a publication of pre-clinical studies supporting the efficacy and drug delivery mechanism of RenovoRx’s Trans-Arterial Micro-Perfusion (“TAMP”) therapy platform.

加利福尼亚州洛斯阿尔托斯市——（商业新闻短讯）——RenovoRx，Inc.（“RenovoRx”或“公司”）（纳斯达克：RNXT），一家临床阶段的生物制药公司，开发基于当地药物输送平台的新型精确肿瘤疗法，今天宣布发表一份临床前研究，支持RenovoRx的经动脉微灌注（“TAMP”）治疗平台的功效和药物输送机制。

The data was published online in the peer-reviewed Journal of Vascular Interventional Radiology(“JVIR”) journal and will also be published in the print version..

该数据已在同行评审的《血管介入放射学杂志》（“JVIR”）杂志上在线发布，也将以印刷版发布。。

The manuscript is authored by Khashayar Farsad, MD, PhD of the Department of Interventional Radiology at Oregon Health and Science University, and co-authored by Paula M. Novelli, MD, of the University of Pittsburgh Hillman Cancer Center, together with other researchers, including RenovoRx’s Chief Medical Officer, Dr.

该手稿由俄勒冈州健康与科学大学介入放射学系医学博士Khashayar Farsad撰写，匹兹堡大学希尔曼癌症中心医学博士PaulaM.Novelli与其他研究人员共同撰写，包括RenovoRx的首席医学官Dr。

Ramtin Agah. Access the JVIR abstract: https://pubmed.ncbi.nlm.nih.gov/38508449/..

拉姆丁·阿加。访问JVIR摘要：https://pubmed.ncbi.nlm.nih.gov/38508449/..

Currently, most cancer patients with solid tumors receive chemotherapy intravenously, meaning it is introduced systemically into the entire body and causes well known adverse side effects. RenovoRx’s patented TAMP therapy platform is designed to bypass traditional systemic delivery methods and provide precise delivery to bathe the target solid tumor in chemotherapy.

目前，大多数患有实体瘤的癌症患者接受静脉化疗，这意味着它被全身引入全身，并引起众所周知的不良副作用。RenovoRx获得专利的TAMP治疗平台旨在绕过传统的全身给药方法，并提供精确的给药，以在化疗中沐浴目标实体瘤。

This precise delivery also creates the potential to minimize a therapy’s systemic toxicities..

这种精确的分娩也有可能最大程度地减少治疗的全身毒性。。

The pre-clinical data published in JVIR showed a 100-fold (two orders of magnitude) increase in local tissue concentration of the therapy with TAMP compared to conventional intravenous (IV) delivery. TAMP also showed advantages compared to historically available intra-arterial (IA) delivery approaches.

JVIR上公布的临床前数据显示，与常规静脉内（IV）递送相比，TAMP治疗的局部组织浓度增加了100倍（两个数量级）。与历史上可用的动脉内（IA）递送方法相比，TAMP也显示出优势。

TAMP’s novel approach to treatment offers the potential to increase an oncology therapy’s efficacy, improve safety, and widen its therapeutic window by focusing its distribution uniformly in target tissue..

TAMP的新型治疗方法有可能提高肿瘤治疗的疗效，提高安全性，并通过将其均匀分布在靶组织中来扩大其治疗窗口。。

“TAMP has the potential to provide a valuable treatment option to patients who have been diagnosed with solid tumors that may be difficult-to-treat,” said Dr. Farsad. “The study shows a possible mechanism for how TAMP can increase local therapeutic tissue concentration in solid tumors that is independent from traditional catheter-directed therapy.

Farsad博士说：“TAMP有可能为被诊断患有可能难以治疗的实体瘤的患者提供有价值的治疗选择。”。“该研究显示了TAMP如何增加实体瘤局部治疗组织浓度的可能机制，这与传统的导管导向治疗无关。

We are awaiting final outcomes of the Phase III clinical trial, currently underway, to validate this benefit.”.

我们正在等待目前正在进行的III期临床试验的最终结果，以验证这一益处。”。

Dr. Farsad adds, “This platform has the potential to extend across a variety of unmet needs for localized therapeutic drug delivery.”

Farsad博士补充道：“这个平台有可能扩展到各种未满足的局部治疗药物输送需求。”

About the Phase III TIGeR-PaC Clinical Trial

关于TIGeR PaC III期临床试验

TIGeR-PaC is RenovoRx’s ongoing Phase III randomized multi-center study evaluating the proprietary TAMP therapy platform for the treatment of Locally Advanced Pancreatic Cancer (LAPC.) RenovoRx’s first product candidate, RenovoGem™, is a novel oncology drug-delivery combination utilizing TAMP administration technology combined with the FDA-approved chemotherapy, gemcitabine.

TIGeR PaC是RenovoRx正在进行的III期随机多中心研究，评估用于治疗局部晚期胰腺癌（LAPC）的专有TAMP治疗平台。RenovoRx的第一个候选产品RenovoGem™是一种新型的肿瘤药物递送组合，利用TAMP给药技术结合FDA批准的化疗吉西他滨。

The TIGeR-PaC study is comparing treatment with TAMP to systemic intravenous chemotherapy, the current standard of care..

TIGeR PaC研究比较了TAMP与全身静脉化疗（目前的护理标准）的治疗效果。。

The first interim analysis in the TIGeR-PaC study occurred at the 26th event of the specified events (deaths), and was completed in March 2023, with the Data Monitoring Committee recommending a continuation of the study. The TIGeR-PaC study’s primary endpoint is a 6-month Overall Survival (OS) benefit with secondary endpoints including reduced side effects versus standard of care..

TIGeR PaC研究的第一次中期分析发生在指定事件（死亡）的第26次事件中，并于2023年3月完成，数据监测委员会建议继续研究。TIGeR PaC研究的主要终点是6个月的总生存期（OS）益处，次要终点包括与标准护理相比减少的副作用。。

About Locally Advanced Pancreatic Cancer (LAPC)

关于局部晚期胰腺癌（LAPC）

According to American Cancer Society’s Cancer Facts & Figures 2023, pancreatic cancer has a 5-year combined overall survival rate of 13% (Stages I-IV) and is on track to be the second leading cause of cancer-related deaths before 2030. LAPC is diagnosed when the disease has not spread far beyond the pancreas, however, has advanced to the point where it cannot be surgically removed.

根据美国癌症协会2023年的癌症事实和数字，胰腺癌的5年总生存率为13%（I-IV期），有望成为2030年之前癌症相关死亡的第二大原因。LAPC是在疾病尚未扩散到胰腺之外时被诊断出来的，然而，疾病已经发展到无法通过手术切除的程度。

LAPC is typically associated with patients in Stage 3 of the disease as determined by the TNM (tumor, nodes and metastasis) grading system..

LAPC通常与TNM（肿瘤，淋巴结和转移）分级系统确定的疾病3期患者相关。。

About RenovoRx, Inc.

关于RenovoRx，股份有限公司。

RenovoRx is a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a proprietary local drug-delivery platform for high unmet medical need with a goal to improve therapeutic outcomes for cancer patients undergoing treatment. RenovoRx’s patented Trans-Arterial Micro-Perfusion (TAMP™) therapy platform is designed to ensure precise therapeutic delivery to directly target the tumor while potentially minimizing a therapy’s toxicities versus systemic intravenous therapy.

RenovoRx是一家临床阶段的生物制药公司，开发基于专有本地药物输送平台的新型精确肿瘤疗法，以满足高度未满足的医疗需求，旨在改善接受治疗的癌症患者的治疗效果。RenovoRx获得专利的经动脉微灌注（TAMP™）治疗平台旨在确保精确的治疗输送，以直接靶向肿瘤，同时与全身静脉治疗相比，潜在地最大程度地降低治疗的毒性。

RenovoRx’s novel and patented approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy. Our Phase III lead product candidate, RenovoGem™, a novel oncology drug-device combination product, is being investigated under a U.S. investigational new drug application that is regulated by the FDA’s 21 CFR 312 pathway.

RenovoRx的新型专利靶向治疗方法具有提高安全性，耐受性和改善疗效的潜力。我们的III期主要候选产品RenovoGem™是一种新型肿瘤药物-器械组合产品，正在美国FDA 21 CFR 312途径监管的研究性新药申请下进行调查。

RenovoGem is currently being evaluated for the treatment of locally advanced pancreatic cancer by the Center for Drug Evaluation and Research (the drug division of FDA.).

RenovoGem目前正在接受药物评估和研究中心（FDA药物部门）对局部晚期胰腺癌的治疗进行评估。

RenovoRx is committed to transforming the lives of patients by delivering innovative solutions to change the current paradigm of cancer care. RenovoGem is currently under investigation for TAMP therapeutic delivery of gemcitabine and has not been approved for commercial sale.

RenovoRx致力于通过提供创新的解决方案来改变目前的癌症护理模式，从而改变患者的生活。RenovoGem目前正在研究TAMP治疗吉西他滨，尚未批准商业销售。

For more information, visit www.renovorx.com. Follow RenovoRx on Facebook, LinkedIn, and Twitter.

有关更多信息，请访问www.renovorx.com。在Facebook、LinkedIn和Twitter上关注renovorx。

Cautionary Note Regarding Forward-Looking Statements

关于前瞻性声明的警示说明

This press release and statements of the Company’s management made in connection therewith contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934, including but not limited to statements regarding (i) our clinical trials and studies, including anticipated timing, statements regarding the potential of RenovoCath®, RenovoGem™ or TAMP™ or regarding our ongoing TIGeR-PaC Phase III clinical trial study in LAPC, (ii) the potential for our product candidates to treat or provide clinically meaningful outcomes for certain medical conditions or diseases and (iii) our efforts to expand our intellectual property.

本新闻稿和公司管理层就此发表的声明包含《1933年证券法》第27A节和《1934年证券交易法》第21E节所指的前瞻性声明，包括但不限于以下声明：（i）我们的临床试验和研究，包括预期时间，关于RenovoCath®、RenovoGem™或TAMP™潜力的声明，或关于我们正在LAPC进行的TIGeR PaC III期临床试验研究的声明，（ii）我们的候选产品治疗某些医疗条件或疾病或提供临床有意义结果的潜力，以及（III）我们扩大知识产权的努力。

Statements that are not purely historical are forward-looking statements. The forward-looking statements contained herein are based upon our current expectations and beliefs regarding future events, many of which, by their nature, are inherently uncertain, outside of our control and involve assumptions that may never materialize or may prove to be incorrect.

不纯粹是历史性的陈述是前瞻性陈述。本文所含的前瞻性陈述基于我们目前对未来事件的期望和信念，其中许多本质上是不确定的，超出了我们的控制范围，并且涉及可能永远不会实现或可能被证明是不正确的假设。

These may include estimates, projections and statements relating to our research and development plans, intellectual property development, clinical trials, our therapy platform, business plans, financing plans, objectives and expected operating results, which are based on current expectations and assumptions that are subject to known and unknown risks and uncertainties that may cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements.

这些可能包括与我们的研发计划、知识产权开发、临床试验、我们的治疗平台、商业计划、融资计划、目标和预期经营成果有关的估计、预测和陈述，这些估计、预测和陈述基于当前的预期和假设，这些预期和假设受到已知和未知风险和不确定性的影响，这些风险和不确定性可能导致实际结果与这些前瞻性陈述所表达或暗示的结果存在重大不利差异。

These statements may be identified using words such as “may,” “expects,” “plans,” “aims,” “anticipates,” “believes,” “forecasts,” “estimates,” “intends,” and “potential,” or the negative of these terms or other comparable t.

这些陈述可以使用“可能”、“预期”、“计划”、“目标”、“预期”、“相信”、“预测”、“估计”、“打算”和“潜力”等词语，或者这些术语的否定词或其他类似的t。

Forward-looking statements included herein are made as of the date hereof, and RenovoRx does not undertake any obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as required by law.

本文件中包含的前瞻性声明是在本文件签署之日做出的，除法律要求外，RenovoRx不承担任何义务公开更新此类前瞻性声明以反映后续事件或情况。