RenovoRx Highlights New Human Pharmacokinetic Data Abstract at SSO 2025 Annual Meeting
RenovoRx (RNXT) presented new human pharmacokinetic data at the SSO 2025 Annual Meeting, highlighting their Trans-Arterial Micro-Perfusion (TAMP) therapy platform. The study focused on their Phase III investigational drug-device combination using intra-arterial gemcitabine (IAG) with the FDA-cleared RenovoCath device.
The research, presented in abstract ePoster P379, analyzed 19 patients with locally advanced pancreatic cancer (LAPC) from six sites in the TIGeR-PaC trial. Key findings showed that localized, dual-balloon catheter-mediated IAG resulted in lower systemic levels compared to intravenous gemcitabine delivery, suggesting potential reduced chemotherapy-related side effects.
The abstract, authored by Dr. Emmanuel E. Zervos of East Carolina University and co-authored by RenovoRx's founder and CMO Dr. Ramtin Agah, demonstrates TAMP's potential as an alternative treatment for LAPC patients who struggle with traditional systemic regimens.
RenovoRx (RNXT) ha presentato nuovi dati di farmacocinetica umana durante il Meeting Annuale SSO 2025, evidenziando la loro piattaforma di terapia Trans-Arterial Micro-Perfusion (TAMP). Lo studio si è concentrato sulla loro combinazione di farmaco-dispositivo in fase III che utilizza la gemcitabina intra-arteriosa (IAG) con il dispositivo RenovoCath, approvato dalla FDA.
La ricerca, presentata nell'abstract ePoster P379, ha analizzato 19 pazienti con cancro pancreatico localmente avanzato (LAPC) provenienti da sei siti della sperimentazione TIGeR-PaC. I risultati chiave hanno mostrato che l'IAG mediata da cateteri a doppio pallone localizzati ha comportato livelli sistemici inferiori rispetto alla somministrazione endovenosa di gemcitabina, suggerendo potenziali effetti collaterali ridotti legati alla chemioterapia.
L'abstract, redatto dal Dr. Emmanuel E. Zervos dell'Università della Carolina Orientale e co-autore dal fondatore e CMO di RenovoRx, Dr. Ramtin Agah, dimostra il potenziale del TAMP come trattamento alternativo per i pazienti affetti da LAPC che hanno difficoltà con i regimi sistemici tradizionali.
RenovoRx (RNXT) presentó nuevos datos de farmacocinética humana en la Reunión Anual SSO 2025, destacando su plataforma de terapia de Microperfusión Transarterial (TAMP). El estudio se centró en su combinación de fármaco-dispositivo en fase III que utiliza gemcitabina intra-arterial (IAG) con el dispositivo RenovoCath, aprobado por la FDA.
La investigación, presentada en el abstract ePoster P379, analizó a 19 pacientes con cáncer pancreático localmente avanzado (LAPC) de seis sitios en el ensayo TIGeR-PaC. Los hallazgos clave mostraron que la IAG mediada por catéteres de doble globo localizados resultó en niveles sistémicos más bajos en comparación con la administración intravenosa de gemcitabina, lo que sugiere posibles efectos secundarios reducidos relacionados con la quimioterapia.
El abstract, escrito por el Dr. Emmanuel E. Zervos de la Universidad de Carolina del Este y co-autorado por el fundador y CMO de RenovoRx, Dr. Ramtin Agah, demuestra el potencial de TAMP como un tratamiento alternativo para pacientes con LAPC que tienen dificultades con los regímenes sistémicos tradicionales.
RenovoRx (RNXT)는 SSO 2025 연례 회의에서 새로운 인간 약리학적 데이터를 발표하며, 그들의 경동맥 미세관류(TAMP) 치료 플랫폼을 강조했습니다. 이 연구는 FDA 승인을 받은 RenovoCath 장치를 사용한 경동맥 내 젬시타빈(IAG)과 관련된 3상 임상 시험 약물-장치 조합에 중점을 두었습니다.
ePoster P379에 발표된 연구에서는 TIGeR-PaC 시험의 6개 사이트에서 진행된 19명의 국소 진행성 췌장암(LAPC) 환자를 분석했습니다. 주요 발견은 국소 이중 풍선 카테터를 통한 IAG가 정맥 내 젬시타빈 투여에 비해 전신 수준이 낮다는 것을 보여주어, 화학요법 관련 부작용이 줄어들 가능성을 시사합니다.
이 초록은 동부 카롤라이나 대학교의 Emmanuel E. Zervos 박사에 의해 작성되었으며, RenovoRx의 창립자이자 CMO인 Ramtin Agah 박사가 공동 저자로 참여하였습니다. 이는 TAMP가 전통적인 전신 요법에 어려움을 겪는 LAPC 환자에게 대안 치료로서의 잠재력을 보여줍니다.
RenovoRx (RNXT) a présenté de nouvelles données pharmacocinétiques humaines lors de la Réunion Annuelle SSO 2025, mettant en avant leur plateforme de thérapie de Micro-Perfusion Trans-Artérielle (TAMP). L'étude s'est concentrée sur leur combinaison de médicament-dispositif en phase III utilisant de la gemcitabine intra-artérielle (IAG) avec le dispositif RenovoCath, approuvé par la FDA.
La recherche, présentée dans l'abstract ePoster P379, a analysé 19 patients atteints de cancer du pancréas localement avancé (LAPC) provenant de six sites de l'essai TIGeR-PaC. Les résultats clés ont montré que l'IAG médiée par cathéter à double ballon localisé a entraîné des niveaux systémiques inférieurs par rapport à l'administration intraveineuse de gemcitabine, suggérant un potentiel de réduction des effets secondaires liés à la chimiothérapie.
L'abstract, rédigé par le Dr Emmanuel E. Zervos de l'Université de Caroline de l'Est et coécrit par le fondateur et CMO de RenovoRx, Dr Ramtin Agah, démontre le potentiel du TAMP comme traitement alternatif pour les patients atteints de LAPC qui ont des difficultés avec les régimes systémiques traditionnels.
RenovoRx (RNXT) präsentierte neue humanpharmakokinetische Daten auf dem SSO-Jahrestreffen 2025 und hob ihre Trans-Arterial Micro-Perfusion (TAMP) Therapieplattform hervor. Die Studie konzentrierte sich auf ihre Phase-III-Studie mit einer Kombination aus Medikament und Gerät, die intra-arterielle Gemcitabin (IAG) mit dem von der FDA zugelassenen RenovoCath-Gerät verwendet.
Die Forschung, die im Abstract ePoster P379 präsentiert wurde, analysierte 19 Patienten mit lokal fortgeschrittenem Pankreaskrebs (LAPC) von sechs Standorten der TIGeR-PaC-Studie. Wichtige Ergebnisse zeigten, dass die lokalisierten, dualen Ballonkatheter-vermittelten IAG im Vergleich zur intravenösen Gemcitabin-Verabreichung niedrigere systemische Werte ergab, was auf potenziell reduzierte chemotherapiebedingte Nebenwirkungen hindeutet.
Das Abstract, verfasst von Dr. Emmanuel E. Zervos von der East Carolina University und mitverfasst von dem Gründer und CMO von RenovoRx, Dr. Ramtin Agah, zeigt das Potenzial von TAMP als alternative Behandlung für LAPC-Patienten, die mit traditionellen systemischen Regimen kämpfen.
- FDA-cleared RenovoCath device demonstrates improved drug delivery method
- Clinical data shows reduced systemic exposure to chemotherapy
- Potential for decreased side effects while maintaining treatment efficacy
- Platform shows promise as alternative for patients intolerant to traditional treatments
- Final outcomes of Phase III TIGeR-PaC trial still pending
- patient sample size (19) in current analysis
Insights
This pharmacokinetic (PK) data presentation at SSO 2025 provides meaningful validation for RenovoRx's targeted drug delivery approach. The results showing lower systemic exposure with their dual-balloon Trans-Arterial Micro-Perfusion (TAMP) platform compared to standard IV delivery represents a critical mechanism validation for their technology.
What's particularly notable is that this data comes from actual patients (19 participants) in their ongoing Phase III TIGeR-PaC trial, not just preclinical models. Pancreatic cancer patients often struggle with debilitating side effects from systemic chemotherapy, limiting treatment intensity and duration. A delivery system that maintains local therapeutic drug concentrations while minimizing systemic exposure addresses a fundamental challenge in pancreatic cancer treatment.
The correlation with patient-reported outcomes further strengthens the clinical relevance, suggesting patients experienced fewer systemic adverse effects. This could potentially allow for more tolerable treatment regimens or extended duration therapy.
While this data supports the mechanistic foundation of their approach, investors should recognize these are interim findings. The definitive value proposition depends on whether this translates to the primary endpoint in their Phase III study - likely overall survival or progression-free survival metrics. The reduced systemic exposure is promising but represents a surrogate endpoint that must ultimately demonstrate clinical benefit.
This pharmacokinetic data represents a positive technical validation for RenovoRx's proprietary TAMP platform and RenovoCath delivery device. For a micro-cap company (
The presentation at a respected surgical oncology conference provides third-party credibility, particularly with lead author Dr. Zervos from East Carolina University (not a company employee). The data supports RenovoRx's fundamental value proposition of targeted delivery to enhance efficacy while reducing toxicity.
For context, pancreatic cancer remains one of the most treatment-resistant malignancies, with innovation in delivery mechanisms. RenovoRx's approach represents a platform technology that, if successful, could potentially extend beyond pancreatic cancer to other localized solid tumors.
Investors should recognize that while this PK data validates their technological approach, the ultimate value inflection point remains the final Phase III TIGeR-PaC trial results. The company has a relatively small cash position, making positive data particularly important for future financing opportunities. The FDA-cleared RenovoCath device provides some commercial foundation, but the real value driver is demonstrating clinical benefit in their Phase III program targeting the $2B+ pancreatic cancer market.
Data supports the novel Trans-Arterial Micro-Perfusion (TAMPTM) therapy platform for targeted chemotherapy delivery for the potential to minimize a therapy’s toxicities versus systemic intravenous therapies
Data shows localized, intra-arterial delivery of gemcitabine with FDA-cleared RenovoCath® device (known as IAG) resulted in lower systemic levels of drug compared to intravenous delivery of gemcitabine
The abstract provides new human PK data relevant to RenovoRx’s proprietary Trans-Arterial Micro-Perfusion (TAMPTM) therapy platform. TAMP is key to the Company’s Phase III investigational drug-device combination oncology product candidate (intra-arterial gemcitabine, with RenovoCath, known as IAG) and is designed to ensure targeted 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 therapies. RenovoRx’s novel approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy.
The abstract, titled “Pharmacodynamics of Intra-arterial vs. Intravenous Gemcitabine in Locally Advanced Pancreatic Cancer: Results of a Phase III Randomized Clinical Trial,” was authored by Emmanuel E. Zervos, M.D. of East Carolina University, and co-authored by Ramtin Agah, M.D., founder and Chief Medical Officer of RenovoRx and others.
“The data presented in this abstract support the potential for the TAMP therapy platform to provide a meaningful advancement in the standard of care for oncology therapy in difficult-to-treat tumors,” said Dr. Zervos. “This study shows additional support for TAMP as a potential treatment option in locally advanced pancreatic cancer (LAPC). Specifically, in this analysis, localized, dual-balloon catheter-mediated IAG resulted in lower systemic levels of gemcitabine compared to intravenous gemcitabine. IAG may prove beneficial in decreasing chemotherapy-related systemic side effects. We are awaiting final outcomes in the ongoing Phase III TIGeR-PaC clinical trial for IAG to validate this benefit.”
PK analyses were performed on 19 patients with locally advanced pancreatic cancer receiving IAG from six sites as part of the TIGeR-PaC trial. In this analysis, localized, dual-balloon catheter-mediated IAG resulted in lower systemic levels compared to intravenous delivery of gemcitabine. As such, the study found that IAG may be beneficial in decreasing chemotherapy-related systemic side effects. Correlative patient reported outcomes in patients receiving IAG supports this approach as an alternative for LAPC patients who are having difficulty tolerating more traditional systemic regimens.
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 LAPC. RenovoRx’s first investigational drug-device combination product candidate using the TAMP therapy platform enabled with the Company’s FDA-cleared RenovoCath® device for the intra-arterial administration of chemotherapy, gemcitabine (IAG).
About RenovoRx, Inc.
RenovoRx (Nasdaq: RNXT) is a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath®, a novel,
In addition to the RenovoCath device, RenovoRx is also evaluating our novel Phase III drug-device combination oncology product candidate (intra-arterial gemcitabine, known as IAG). IAG is being evaluated under a
The combination product candidate, which is enabled the RenovoCath device, 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 new drug application approval by the FDA.
RenovoRx is also engaged in implementing commercialization strategies utilizing its TAMP technology and FDA-cleared RenovoCath device as stand-alone device. In December 2024, RenovoRx announced the receipt of its first commercial purchase orders for RenovoCath devices. Additionally, certain of these customers have already initiated repeat orders as RenovoRx works to expand the number medical institutions that have initiated the process for RenovoCath purchase orders, including several esteemed, high volume National Cancer Institute-designated centers. To meet and satisfy the anticipated demand, RenovoRx will continue to actively explore further revenue-generating activity either on its own or in tandem with a medical device commercial partner.
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 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 pre-clinical and clinical trials and studies, including the overall timing and timing for additional interim data readouts and full patient enrollment for our ongoing TIGeR-PaC Phase III clinical trial study in LAPC, (ii) the potential of RenovoCath® or TAMP™ as standalone commercial products, our anticipated timing for revenue generation from RenovoCath sales, and our commercialization plans in general, including our estimates of total addressable market (iii) the potential for our product candidates to treat or provide clinically meaningful outcomes for certain medical conditions or diseases and (iv) 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, commercial 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 significant 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 or repeating 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.
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