Northwell Health Cancer Institute Launches Patient Enrollment in RenovoRx’s Ongoing Pivotal Phase III TIGeR-PaC Clinical Trial
RenovoRx (RNXT) announces that Northwell Health Cancer Institute (NHCI) has joined its pivotal Phase III TIGeR-PaC clinical trial for locally advanced pancreatic cancer (LAPC). The trial evaluates RenovoRx's TAMP™ (Trans-Arterial Micro-Perfusion) therapy platform, comparing intra-arterial gemcitabine delivery via the FDA-cleared RenovoCath system to standard intravenous chemotherapy. NHCI joins other U.S. clinical sites in the study, which aims to complete enrollment in the first half of 2025.
RenovoRx (RNXT) annuncia che il Northwell Health Cancer Institute (NHCI) ha aderito al suo importante studio clinico di Fase III TIGeR-PaC per il cancro pancreatico localmente avanzato (LAPC). Lo studio valuta la piattaforma terapeutica TAMP™ (Trans-Arterial Micro-Perfusion) di RenovoRx, confrontando la somministrazione intra-arteriosa di gemcitabina tramite il sistema RenovoCath, approvato dalla FDA, con la chemioterapia intravenosa standard. NHCI si unisce ad altri centri clinici negli Stati Uniti per questo studio, che mira a completare l'arruolamento nella prima metà del 2025.
RenovoRx (RNXT) anuncia que el Northwell Health Cancer Institute (NHCI) se ha unido a su importante ensayo clínico de Fase III TIGeR-PaC para el cáncer de páncreas localmente avanzado (LAPC). El ensayo evalúa la plataforma terapéutica TAMP™ (Trans-Arterial Micro-Perfusion) de RenovoRx, comparando la administración intra-arterial de gemcitabina a través del sistema RenovoCath, aprobado por la FDA, con la quimioterapia intravenosa estándar. NHCI se une a otros sitios clínicos en EE. UU. para este estudio, que tiene como objetivo completar la inscripción en la primera mitad de 2025.
RenovoRx (RNXT)는 Northwell Health Cancer Institute (NHCI)가 국소 진행성 췌장암 (LAPC)에 대한 중요한 임상시험 3상 TIGeR-PaC에 참여했다고 발표했습니다. 이 시험은 RenovoRx의 TAMP™ (Trans-Arterial Micro-Perfusion) 치료 플랫폼을 평가하며, FDA 승인된 RenovoCath 시스템을 통한 동맥 내 gemcitabine 투여를 표준 정맥내 화학요법과 비교합니다. NHCI는 본 연구에 참여하는 미국 내 다른 임상 사이트와 함께하며, 2025년 상반기 내에 모집을 완료하는 것을 목표로 하고 있습니다.
RenovoRx (RNXT) annonce que l'Institut de cancer de Northwell Health (NHCI) a rejoint son essai clinique de Phase III TIGeR-PaC sur le cancer du pancréas localement avancé (LAPC). L'essai évalue la plateforme thérapeutique TAMP™ (Trans-Arterial Micro-Perfusion) de RenovoRx, comparant l'administration intra-artérielle de gemcitabine via le système RenovoCath, approuvé par la FDA, à la chimiothérapie intraveineuse standard. Le NHCI rejoint d'autres sites cliniques aux États-Unis dans cette étude, qui vise à compléter l'inscription au cours de la première moitié de 2025.
RenovoRx (RNXT) gibt bekannt, dass das Northwell Health Cancer Institute (NHCI) an seiner maßgeblichen Phase-III-Studie TIGeR-PaC für lokal fortgeschrittenen Bauchspeicheldrüsenkrebs (LAPC) teilnimmt. Die Studie bewertet die Therapietechnologie TAMP™ (Trans-Arterial Micro-Perfusion) von RenovoRx, indem die intra-arterielle Verabreichung von Gemcitabin über das von der FDA zugelassene RenovoCath-System mit der standardmäßigen intravenösen Chemotherapie verglichen wird. NHCI tritt anderen klinischen Standorten in den USA bei, um an der Studie teilzunehmen, die darauf abzielt, die Rekrutierung in der ersten Hälfte von 2025 abzuschließen.
- Partnership with Northwell Health Cancer Institute, one of the largest healthcare systems in New York
- Study aims to complete enrollment by first half of 2025, providing clear timeline
- FDA-cleared RenovoCath delivery system already in place
- Phase III trial still in enrollment phase, with results pending
- No efficacy data presented in the current update
Insights
The initiation of patient enrollment at Northwell Health Cancer Institute for RenovoRx's Phase III TIGeR-PaC trial represents a strategic advancement in their clinical development program. The trial's focus on locally advanced pancreatic cancer (LAPC) using the TAMP delivery platform could potentially address a significant unmet medical need. The expected completion of enrollment in H1 2025 provides a clear timeline for potential interim data readouts.
The TAMP platform's pressure-mediated delivery mechanism, combined with gemcitabine administration through the RenovoCath system, offers a novel approach that could potentially improve the risk-benefit profile compared to standard systemic chemotherapy. Northwell's participation as a major healthcare system adds credibility and could accelerate recruitment, though investors should note that final efficacy data will still be needed to validate the technology.
The Northwell Health Cancer Institute is the Most Recent Clinical Site to Join the TIGeR-PaC Study, and RenovoRx Aims to Reach Full Patient Enrollment in the First Half of 2025
Phase III Clinical Trial is Evaluating the TAMP™ (Trans-Arterial Micro-Perfusion) Therapy Platform for the Treatment of Locally Advanced Pancreatic Cancer
LOS ALTOS, Calif., Nov. 20, 2024 (GLOBE NEWSWIRE) -- RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a life sciences company developing novel targeted oncology therapies and offering RenovoCath®, a novel, FDA-cleared local drug-delivery platform, announced today that the Northwell Health Cancer Institute (“NHCI”) in New Hyde Park, NY is enrolling patients with locally advanced pancreatic cancer (LAPC) in the Company’s ongoing pivotal Phase III TIGeR-PaC clinical trial. NHCI joins esteemed clinical sites throughout the United States participating in the study.
“We are pleased to be part of this pivotal study that holds the potential to transform the way we treat pancreatic cancer,” said Dr. Daniel King, MD, PhD of Medical Oncology at NHCI. “TAMP represents a novel approach to targeted chemotherapy delivery near the tumor site, which may improve efficacy while reducing systemic side effects. This study underscores our deep commitment to advancing cancer treatment and offering our patients access to the latest in therapeutic innovations.”
The TIGeR-PaC study is using RenovoRx’s TAMP (Trans-Arterial Micro-Perfusion) therapy platform, to evaluate the Company’s first drug-device combination product candidate (intra-arterial infusion of gemcitabine via RenovoRx’s FDA-cleared RenovoCath delivery system). TAMP utilizes pressure-mediated delivery of gemcitabine to the target tumor. The study is comparing treatment with TAMP in LAPC to the current standard-of-care (systemic intravenous chemotherapy).
“NHCI is a highly recognized cancer center in the United States and is dedicated to providing patients with access to the latest advances in oncology treatment. Dr. King and his team make an ideal partner for evaluating the potential benefits of our innovative TAMP therapy platform,” said Leesa Gentry, Chief Clinical Officer of RenovoRx. “Working with New York’s largest healthcare system is a major win for RenovoRx. We believe this collaboration will assist the Company in both accelerating patient enrollment in our pivotal Phase III TIGeR-PaC clinical trial and driving the study towards its expected enrollment completion in the first half of 2025.”
About Locally Advanced Pancreatic Cancer (LAPC)
According to the American Cancer Society’s Cancer Facts & Figures 2024 and PanCAN, respectively, pancreatic cancer has a 5-year all stages combined relative survival rate of
About RenovoCath
Based on its FDA clearance, RenovoCath® is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. For further information regarding our RenovoCath Instructions for Use (“IFU”), please see: IFU-10004-Rev.-F-Universal-IFU.pdf.
About the TIGeR-PaC Clinical Trial
TIGeR-PaC is an ongoing Phase III randomized multi-center study evaluating the proprietary TAMP™ (Trans-Arterial Micro-Perfusion) therapy platform for the treatment of Locally Advanced Pancreatic Cancer (LAPC.) RenovoRx’s first product candidate using the TAMP technology, is a novel investigational oncology drug-delivery combination utilizing the Company’s FDA-cleared RenovoCath® device for the intra-arterial administration of chemotherapy, gemcitabine.
The first interim analysis in the Phase III clinical trial was completed in March 2023, with the Data Monitoring Committee recommending a continuation of the study. The TIGeR-PaC study is investigating TAMP in LAPC. The study's primary endpoint is an Overall Survival benefit with secondary endpoints including reduced side effects versus standard of care. The second interim analysis for this study will be triggered by the 52nd event (i.e., patient death), which is estimated to occur in late 2024 or early 2025. The second interim data readout would follow thereafter, with the timing for such readout depending on customary factors such as time needed for analysis. RenovoRx is also aiming to complete patient enrollment in the TIGeR-PaC study in the first half of 2025.
About RenovoRx, Inc.
RenovoRx is a life sciences company developing novel targeted oncology therapies and offering RenovoCath®, a novel, U.S. Food and Drug Administration (FDA)-cleared local drug-delivery platform, targeting high unmet medical needs. RenovoRx’s patented Trans-Arterial Micro-Perfusion (TAMP™) therapy platform is designed to ensure precise therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor, while potentially minimizing a therapy’s toxicities versus systemic intravenous therapy. RenovoRx’s novel approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy, and its mission is to transform the lives of cancer patients by providing innovative solutions to enable targeted delivery of diagnostic and therapeutic agents.
The Company’s Phase III lead product candidate is a novel oncology drug-device combination product. It is being investigated under a U.S. investigational new drug application that is regulated by the FDA’s 21 CFR 312 pathway. The investigational drug-device combination candidate utilizes RenovoCath®, the Company’s FDA-cleared drug-delivery device, indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. The intra-arterial infusion of chemotherapy, gemcitabine, utilizing the RenovoCath catheter 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).
RenovoRx is also actively exploring other commercialization strategies utilizing its TAMP technology and FDA-cleared RenovoCath delivery system as a stand-alone device. The intra-arterial infusion of gemcitabine by the RenovoCath catheter is currently under investigation and has not been approved for commercial sale. RenovoCath with gemcitabine received Orphan Drug Designation for pancreatic cancer and bile duct cancer, which provides 7 years of market exclusivity upon NDA approval by the FDA.
For more information, visit www.renovorx.com. Follow RenovoRx on Facebook, LinkedIn, and Twitter.
Cautionary Note Regarding Forward-Looking Statements
This press release and statements of the Company’s management made in connection therewith and at the investor conference described herein contain 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 the overall timing and timing for additional interim data readouts for our ongoing TIGeR-PaC Phase III clinical trial study in LAPC, (ii) the potential of RenovoCath® or TAMP™ as standalone commercial products and our commercialization plans in general, (iii) the potential for our product candidates to treat or provide clinically meaningful outcomes for certain medical conditions or diseases and (iii) our efforts to explore commercialization strategies utilizing our TAMP technology. 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. 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. 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, although not all forward-looking statements contain these words. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, that could cause actual events to differ materially from those projected or indicated by such statements, including, among other things: (i) the risk that our exploration of commercial opportunities for our TAMP technology may not lead to viable, revenue generating operations; (ii) circumstances which would adversely impact our ability to efficiently utilize our cash resources on hand or raise additional funding, (iii) the timing of the initiation, progress and potential results (including the results of interim analyses) of TIGeR-PaC and any other preclinical studies, clinical trials and our research programs; (iv) the possibility that interim results may not be predictive of the outcome of our clinical trials, which may not demonstrate sufficient safety and efficacy to support regulatory approval of our product candidate, (v) that the applicable regulatory authorities may disagree with our interpretation of the data; research and clinical development plans and timelines, and the regulatory process for our product candidates; (vi) future potential regulatory milestones for our product candidates, including those related to current and planned clinical studies; (vii) our ability to use and expand our therapy platform to build a pipeline of product candidates; (viii) our ability to advance product candidates into, and successfully complete, clinical trials; (ix) the timing or likelihood of regulatory filings and approvals; (x) our estimates of the number of patients who suffer from the diseases we are targeting and the number of patients that may enroll in our clinical trials; (xi) the commercialization potential of our product candidates, if approved; (xii) our ability and the potential to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved; (xiii) future strategic arrangements and/or collaborations and the potential benefits of such arrangements; (xiv) our estimates regarding expenses, future revenue, capital requirements and needs for additional financing and our ability to obtain additional capital; (xv) the sufficiency of our existing cash and cash equivalents to fund our future operating expenses and capital expenditure requirements; (xvi) our ability to retain the continued service of our key personnel and to identify, and hire and retain additional qualified personnel; (xvii) the implementation of our strategic plans for our business and product candidates; (xviii) the scope of protection we are able to establish and maintain for intellectual property rights, including our therapy platform, product candidates and research programs; (xix) our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; (xx) the pricing, coverage and reimbursement of our product candidates, if approved; and (xxi) developments relating to our competitors and our industry, including competing product candidates and therapies. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in documents that we file from time to time with the Securities and Exchange Commission.
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.
Contact:
KCSA Strategic Communications
Valter Pinto or Jack Perkins
T:212-896-1254
RenovoRX@KCSA.com
FAQ
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