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 the expansion of their clinical development pipeline in preparation for the commencement of a second Phase III trial.

加利福尼亚州洛斯阿尔托斯市——（商业新闻短讯）——雷诺沃克斯公司（“雷诺沃克斯”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，今天宣布扩大其临床开发渠道，为第二阶段III期试验的开始做准备。

The CouGar Trial will evaluate RenovoGem in bile duct cancer, specifically unresectable locally advanced extrahepatic cholangiocarcinoma (eCCA)..

CouGar试验将评估RenovoGem在胆管癌中的作用，特别是不可切除的局部晚期肝外胆管癌（eCCA）。。

“We are pleased to engage our first clinical site for our second pivotal clinical trial. The CouGar Trial marks an important milestone for RenovoRx as we expand our clinical pipeline for RenovoGem into bile duct cancer, a difficult-to-treat solid tumor cancer,” said Leesa Gentry, Senior Vice President of Clinical Operations at RenovoRx.

RenovoRx临床运营高级副总裁Leesa Gentry说：“我们很高兴能让我们的第一个临床站点参与我们的第二个关键临床试验。CouGar试验标志着RenovoRx的一个重要里程碑，因为我们将RenovoGem的临床管道扩展到胆管癌，这是一种难以治疗的实体瘤癌症。”。

“I’m extremely proud of our team and our collaborators for their tremendous work reinforcing our mission to improve patient lives by delivering innovative therapies that can potentially change the current paradigm of cancer care.”.

“我为我们的团队和合作者所做的巨大工作感到非常骄傲，他们通过提供创新疗法来加强我们改善患者生活的使命，这些疗法可能会改变目前的癌症护理模式。”。

The pivotal Phase III CouGar study is a randomized study designed to evaluate the safety and efficacy of unresectable, locally advanced eCCA using intravenous cisplatin, gemcitabine, and durvalumab (all forms of chemotherapy) versus Trans-Arterial Micro-Perfusion via RenovoGem (delivery system and gemcitabine) with intravenous durvalumab.

关键的III期CouGar研究是一项随机研究，旨在评估使用静脉顺铂，吉西他滨和durvalumab（所有形式的化疗）与通过RenovoGem（递送系统和吉西他滨）经动脉微灌注的不可切除的局部晚期eCCA的安全性和有效性静脉注射durvalumab。

Oklahoma University (OU) Health is the first clinical site for the CouGar study..

俄克拉荷马大学（OU）Health是美洲狮研究的第一个临床站点。。

“Unfortunately, bile duct cancer today has a poor prognosis for patients. Despite early diagnosis, the five-year survival rate is approximately 24%,” said Paula Novelli, MD FSIR, CouGar National Principal Investigator, and Associate Professor of Radiology and Director of Interventional Radiology Research at the University of Pittsburgh Medical Center.

“不幸的是，今天胆管癌患者的预后很差。尽管早期诊断，但五年生存率约为24%，”美洲狮国家首席研究员、放射学副教授兼匹兹堡大学医学中心介入放射学研究主任Paula Novelli说。

“There are currently limited treatment options for patients diagnosed with this aggressive cancer, which only prolongs life by a few months. The CouGar study brings hope for a new treatment option. RenovoGem has the potential to meet the urgent clinical need for a safe and effective therapy in this important patient population.”.

“目前，被诊断患有这种侵袭性癌症的患者的治疗选择有限，只能延长几个月的寿命。美洲狮研究为新的治疗选择带来了希望。RenovoGem有可能满足这一重要患者群体对安全有效治疗的迫切临床需求。”。

Dr. David Geller, Director, UPMC Liver Cancer Center, Richard L. Simmons Professor of Surgery, University of Pittsburgh School of Medicine is the CouGar study’s Co-Investigator.

UPMC肝癌中心主任David Geller博士、匹兹堡大学医学院外科教授Richard L.Simmons是这项美洲狮研究的联合研究者。

“The current standard of care for bile duct cancer is systemic (intravenous) chemotherapy, which has poor uptake and delivery since there are few blood vessels feeding this type of tumor,” said Dr. Hassan Hatoum, Principal Investigator, Associate Professor and Hematologist and Oncologist at Oklahoma University Health Stephenson Cancer Center – Gastrointestinal Cancer Clinic.

俄克拉荷马大学健康史蒂芬森癌症中心胃肠道癌症诊所首席研究员、副教授、血液学家和肿瘤学家哈桑·哈图姆博士说：“目前胆管癌的治疗标准是全身（静脉）化疗，由于几乎没有血管喂养这种肿瘤，因此摄取和输送较差。”。

“RenovoRx’s clinical trial is evaluating targeted, trans-arterial delivery of chemotherapy that is locally directed to the tumor site. Our team looks forward to participating in the CouGar study to bring this novel therapy to patients.”.

“RenovoRx的临床试验正在评估局部针对肿瘤部位的靶向经动脉化疗。我们的团队期待着参与美洲狮研究，将这种新疗法带给患者。”。

RenovoGem received FDA Orphan Drug Designation for pancreatic cancer and bile duct cancer which provides 7 years of market exclusivity upon NDA approval.

RenovoGem获得了FDA针对胰腺癌和胆管癌的孤儿药指定，该药物在NDA批准后具有7年的市场排他性。

About RenovoRx, Inc.

关于RenovoRx，股份有限公司。

RenovoRx is a clinical-stage biopharmaceutical company developing proprietary targeted combination therapies for high unmet medical need with a goal to improve therapeutic outcomes for cancer patients undergoing treatment. The Company’s proprietary Trans-Arterial Micro-Perfusion (TAMPTM) therapy platform is designed to ensure precise therapeutic delivery to directly target the tumor while potentially minimizing a therapy’s toxicities versus systemic (intravenous (IV) therapy).

RenovoRx是一家临床阶段的生物制药公司，针对高度未满足的医疗需求开发专有的靶向联合疗法，旨在改善接受治疗的癌症患者的治疗效果。该公司专有的经动脉微灌注（TAMPTM）治疗平台旨在确保精确的治疗输送，以直接靶向肿瘤，同时可能最大程度地减少治疗与全身（静脉（IV）治疗）的毒性。

RenovoRx’s unique approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy. Our Phase III lead product candidate, RenovoGemTM, a novel oncology drug-device combination product, is being investigated under a US IND that is regulated by FDA 21 CFR 312 pathway.

RenovoRx独特的靶向治疗方法有可能提高安全性，耐受性和疗效。我们的III期主要候选产品RenovoGemTM是一种新型肿瘤药物-装置组合产品，正在美国IND下进行调查，该IND受FDA 21 CFR 312途径的监管。

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

RenovoGem目前正在由药物评估和研究中心（FDA药物部门）对局部晚期胰腺癌（LAPC）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。

Forward-Looking Statements

前瞻性声明

This press release 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 our clinical trials and studies, including anticipated timing, statements regarding the potential of RenovoCath®, RenovoGemTM or TAMPTM or regarding our ongoing TIGeR-PaC Phase III clinical trial study in LAPC, statements regarding the potential for our product candidates to treat or provide clinically meaningful outcomes for certain medical conditions or diseases, and our preliminary financial results, cash position and related ability to continue as a going concern.

本新闻稿包含《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，包括但不限于关于我们临床试验和研究的声明，包括预期时间，关于RenovoCath®潜力的声明，RenovoGemTM或TAMPTM或关于我们正在LAPC进行的TIGeR PaC III期临床试验研究，关于我们的候选产品治疗某些医疗状况或疾病或提供临床有意义结果的潜力的声明，以及我们的初步财务结果，现金状况和相关持续经营能力。

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, clinical trials, therapy platform, business 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 from those expressed or implied by these forward-looking statements.

这些可能包括与我们的研发计划、临床试验、治疗平台、商业计划、目标和预期经营成果有关的估计、预测和声明，这是基于当前的预期和假设，这些预期和假设受到已知和未知的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声明中明示或暗示的结果存在重大差异。

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 terminology regarding RenovoRx’s expectations strategy, plans or intentions, altho.

这些陈述可以使用诸如“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与RenovoRx的预期策略、计划或意图有关的类似术语来识别。

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。