RenovoRx Announces Acceptance of Abstract for Presentation at ASCO Gastrointestinal Cancers Symposium 2025
RenovoRx (RNXT) announced the acceptance of three abstracts for presentation at major industry conferences: ASCO GI 2025, SIO 2025, and SSO 2025. The abstracts focus on the company's Trans-Arterial Micro-Perfusion (TAMP™) therapy platform, presenting additional human pharmacokinetic data and pre-clinical results.
The presentations will highlight RenovoRx's novel approach using their FDA-cleared RenovoCath® delivery platform, which is designed to deliver targeted oncology therapies directly to tumor sites while potentially reducing toxicity compared to systemic treatments. The company's ongoing Phase III TIGeR-PaC clinical trial is evaluating their first product candidate, combining RenovoCath with gemcitabine chemotherapy. RenovoRx expects to complete both patient enrollment and the second interim analysis for TIGeR-PaC by the end of H1 2025.
RenovoRx (RNXT) ha annunciato l'accettazione di tre abstract per presentazioni in importanti conferenze del settore: ASCO GI 2025, SIO 2025 e SSO 2025. Gli abstract si concentrano sulla piattaforma terapeutica Trans-Arterial Micro-Perfusion (TAMP™) dell'azienda, presentando ulteriori dati farmacocinetici umani e risultati pre-clinici.
Le presentazioni metteranno in evidenza l'approccio innovativo di RenovoRx, utilizzando la loro piattaforma di somministrazione RenovoCath® approvata dalla FDA, progettata per somministrare terapie oncologiche mirate direttamente nei siti tumorali, riducendo potenzialmente la tossicità rispetto ai trattamenti sistemici. La fase III della sperimentazione clinica TIGeR-PaC dell'azienda sta valutando il loro primo candidato al prodotto, combinando RenovoCath con la chemioterapia a base di gemcitabina. RenovoRx prevede di completare sia l'arruolamento dei pazienti che la seconda analisi intermedia per TIGeR-PaC entro la fine del primo semestre del 2025.
RenovoRx (RNXT) anunció la aceptación de tres resúmenes para presentación en importantes conferencias de la industria: ASCO GI 2025, SIO 2025 y SSO 2025. Los resúmenes se centran en la plataforma de terapia de Microperfuión Transarterial (TAMP™) de la empresa, presentando datos adicionales de farmacocinética humana y resultados preclínicos.
Las presentaciones resaltarán el enfoque novedoso de RenovoRx utilizando su plataforma de entrega RenovoCath® aprobada por la FDA, diseñada para administrar terapias oncológicas dirigidas directamente en sitios tumorales, reduciendo potencialmente la toxicidad en comparación con los tratamientos sistémicos. El ensayo clínico de Fase III TIGeR-PaC de la compañía está evaluando su primer candidato a producto, combinando RenovoCath con quimioterapia de gemcitabina. RenovoRx espera completar tanto la inscripción de pacientes como el segundo análisis intermedio para TIGeR-PaC para finales del primer semestre de 2025.
RenovoRx (RNXT)는 ASCO GI 2025, SIO 2025 및 SSO 2025와 같은 주요 산업 회의에서 발표할 세 개의 초록이 수락되었다고 발표했습니다. 이 초록들은 회사의 관상동맥 미세관류 치료 플랫폼 (TAMP™)에 초점을 맞추고 있으며, 추가적인 인간 약리학적 데이터와 전임상 결과를 제시합니다.
발표에서는 FDA 승인을 받은 RenovoCath® 전달 플랫폼을 사용한 RenovoRx의 혁신적인 접근 방식이 강조될 것입니다. 이는 종양 부위에 직접 목표로 하는 종양학 치료제를 전달하며, 전신 치료에 비해 독성을 잠재적으로 줄이는 데 설계되었습니다. 회사의 진행 중인 3상 TIGeR-PaC 임상 시험은 RenovoCath와 젬시타빈 화학요법을 결합한 첫 번째 제품 후보를 평가하고 있습니다. RenovoRx는 2025년 1분기 말까지 TIGeR-PaC에 대한 환자 모집과 두 번째 중간 분석을 완료할 것으로 예상하고 있습니다.
RenovoRx (RNXT) a annoncé l'acceptation de trois résumés pour présentation lors de grandes conférences de l'industrie : ASCO GI 2025, SIO 2025 et SSO 2025. Les résumés portent sur la plate-forme de thérapie de Microperfusion Trans-Aortique (TAMP™) de l'entreprise, présentant des données pharmacocinétiques humaines supplémentaires et des résultats précliniques.
Les présentations mettront en avant l'approche novatrice de RenovoRx utilisant leur plate-forme de délivrance RenovoCath® approuvée par la FDA, qui est conçue pour délivrer des thérapies oncologiques ciblées directement sur les sites tumoraux tout en réduisant potentiellement la toxicité par rapport aux traitements systémiques. L'
RenovoRx (RNXT) hat die Annahme von drei Abstracts für Präsentationen auf wichtigen Branchenkonferenzen bekannt gegeben: ASCO GI 2025, SIO 2025 und SSO 2025. Die Abstracts konzentrieren sich auf die Trans-Arterial Micro-Perfusion (TAMP™) Therapieplattform des Unternehmens und präsentieren zusätzliche Daten zur menschlichen Pharmakokinetik und präklinische Ergebnisse.
Die Präsentationen werden den neuartigen Ansatz von RenovoRx mit ihrer von der FDA zugelassenen RenovoCath® Abgabetechnologie hervorheben, die darauf ausgelegt ist, zielgerichtete Onkologietherapien direkt an Tumorstellen zu liefern und dabei potenziell die Toxizität im Vergleich zu systemischen Behandlungen zu reduzieren. Die laufende Phase III TIGeR-PaC klinische Studie des Unternehmens evaluiert den ersten Produktkandidaten, der RenovoCath mit der Chemotherapie Gemcitabin kombiniert. RenovoRx erwartet, dass sowohl die Patientenrekrutie als auch die zweite Zwischenanalyse für TIGeR-PaC bis Ende des ersten Halbjahres 2025 abgeschlossen sind.
- Phase III TIGeR-PaC trial progressing with expected completion of patient enrollment and second interim analysis by H1 2025
- Three abstracts accepted at prestigious industry conferences, demonstrating scientific validation
- FDA-cleared RenovoCath delivery platform already approved for commercial use
- None.
Insights
The acceptance of three abstracts at major oncology conferences is a routine development that primarily serves academic and research purposes. While the abstracts discuss pharmacokinetic data and pre-clinical results for RenovoRx's TAMP platform, they don't present material financial or regulatory progress that would significantly impact the company's market position.
The article's most notable point is the confirmation of timeline for RenovoRx's Phase III TIGeR-PaC trial, with patient enrollment and second interim analysis expected by H1 2025. However, this appears to be a restatement of previously announced timelines rather than new information.
For a micro-cap company (
From an investment perspective, this news represents standard academic dissemination rather than a material catalyst. While the presentations at ASCO GI, SIO and SSO are prestigious venues, they focus on existing data from ongoing research rather than new pivotal results that could influence commercialization prospects.
The key value driver remains the Phase III TIGeR-PaC trial in locally advanced pancreatic cancer (LAPC). The H1 2025 timeline for enrollment completion and second interim analysis represents the next material catalyst. Until then, these conference presentations serve primarily to maintain scientific credibility and visibility within the oncology community.
For investors following RNXT, focus should remain on cash runway through the interim analysis and potential partnership discussions, rather than these academic presentations.
Two additional abstracts have been accepted to be presented at upcoming prestigious industry conferences, SIO 2025 and SSO 2025
The accepted abstracts support RenovoRx’s novel Trans-Arterial Micro-Perfusion (TAMP™) therapy platform via additional human pharmacokinetic (PK) data and pre-clinical data
The abstracts support RenovoRx’s novel and patented TAMP therapy platform via additional human PK data and pre-clinical data. TAMP 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.
RenovoRx’s pivotal ongoing Phase III TIGeR-PaC clinical trial is evaluating the Company’s first product candidate, a novel investigational oncology drug-device combination utilizing the Company’s FDA-cleared RenovoCath device via TAMP for the intra-arterial administration of chemotherapy, gemcitabine. RenovoRx currently anticipates completion of both patient enrollment and the second interim analysis for TIGeR-PaC by the end of the first half of 2025.
Abstract Details:
ASCO GI 2025
- Title: Intra-arterial Gemcitabine Versus Intravenous Gemcitabine: Pharmacokinetic Sub-study of the TIGeR-PaC Phase 3 Clinical Trial
- Authors: Paula Novelli MD, Amer Zureikat MD, Michael Pishvaian MD, Kenneth Meredith MD, Hassan Hatoum MD, Emmanuel Zervos MD, Reza Nazemzadeh MD, Sandeep Loria MD, Ramtin Agah MD
-
Location: Moscone West,
San Francisco CA - Date/Time: January 24, 2025 at 11:30 a.m. PT
SIO 2025
- Title: Micro-CT imaging following intra-arterial delivery of a radiopaque silicone polymer using a double-balloon occlusion catheter in pigs: a model to analyze tissue penetration via the trans-arterial micro perfusion (TAMP) technique
- Authors: Paula Novelli MD, Christopher Laing MD, Aloke Finn MD, Frank Kolodgie PhD, Robert Strasser BSc, Ramtin Agah MD
-
Location: Horseshoe
Las Vegas ,Las Vegas NV - Date/Time: February 2, 2025 at 12:30 p.m. PT
SSO 2025
- Title: Pharmacodynamics of Intra-arterial vs. Intravenous Gemcitabine in Locally Advanced Pancreatic Cancer: Results of a Phase III Randomized Clinical Trial
- Authors: Emmanuel Zervos MD, Paula Novelli MD, Amer Zureikat MD, Michael Pishvaian MD, Kenneth Meredith MD, Hassan Hatoum MD, Reza Nazemzadeh MD, Sandeep Loria MD, Ramtin Agah MD
-
Location:
Tampa Convention Center,Tampa FL - Dates: March 27 – 29, 2025
The abstracts accepted at ASCO GI 2025 and SSO 2025 are sub-studies of the ongoing Phase III TIGeR-PaC clinical trial.
“These abstracts support the potential for our TAMP therapy platform to provide a meaningful advancement in the standard of care for cancer treatment,” said Ramtin Agah, MD, Chief Medical Officer and Founder of RenovoRx. “TAMP focuses on drug concentration optimization in tumors by delivering therapies with our RenovoCath delivery system. This targeted approach to cancer treatment is designed to enable physicians to isolate segments of the vascular anatomy closest to tumors and ensure precise therapeutic delivery, while potentially minimizing a therapy’s toxicities versus the standard of care. Specifically, our approach enables physicians to utilize RenovoCath to use pressure to force chemotherapy across the arterial wall near the tumor site to bathe the target tumor.”
Dr. Agah added, “We also look forward to the completion of patient enrollment and our second interim analysis in our pivotal Phase III TIGeR-PaC clinical trial in LAPC by the end of the first half of 2025.”
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-device 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 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 commercializing RenovoCath®, a novel,
The Company’s Phase III lead product candidate is a novel oncology drug-device combination product. It is being investigated under a
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.
RenovoRx is also actively exploring other commercialization strategies utilizing its TAMP technology and FDA-cleared RenovoCath delivery system as a stand-alone device.
For more information, visit www.renovorx.com. Follow RenovoRx on Facebook, LinkedIn, and X.
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.
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KCSA Strategic Communications
Valter Pinto or Jack Perkins
T:212-896-1254
RenovoRX@KCSA.com
Source: RenovoRx, Inc.
FAQ
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