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RenovoRx Announces Key Phase III Milestone: TIGeR-PaC Trial Surpasses 100 Randomized Patients as Study Nears Completion of Enrollment
Globenewswire· 2026-03-26 12:30
Core Insights - RenovoRx has surpassed 100 randomized patients in its Phase III TIGeR-PaC clinical trial and is on track to complete enrollment in the first half of 2026, with final data expected in 2027 [1][2][3] Company Overview - RenovoRx, Inc. is a life sciences company focused on developing targeted oncology therapies and commercializing RenovoCath®, a patented, FDA-cleared drug-delivery device [6] - The company’s TAMP™ therapy platform aims to deliver therapeutic agents directly to tumor sites while minimizing toxicities associated with systemic intravenous therapy [6] Clinical Trial Progress - The TIGeR-PaC trial requires a total of 114 randomized patients and 86 events (deaths) for final analysis; as of March 24, 2026, 104 patients have been randomized and 72 events have occurred [3] - Interim analyses conducted at the 26th and 52nd events recommended continuation of the trial based on data reviews by the independent data monitoring committee [4] Product Development - The intra-arterial gemcitabine delivered via RenovoCath, known as IAG, is being evaluated in the TIGeR-PaC trial for its potential to treat locally advanced pancreatic cancer [2][9] - RenovoCath has received Orphan Drug Designation for pancreatic cancer and bile duct cancer, which provides seven years of market exclusivity upon FDA approval [10] Commercialization Efforts - RenovoRx is in the early stages of commercializing its TAMP technology and RenovoCath as a stand-alone device, having received its first commercial purchase orders in December 2024 [7][8] - Approximately $900,000 in revenues were generated from RenovoCath sales in the first nine months of 2025, with several customers placing repeat orders [8]
RenovoRx Announces Acceptance of Clinical Data Abstract at the ASCO Gastrointestinal Cancers Symposium 2026
Globenewswire· 2025-12-11 13:30
Core Insights - RenovoRx, Inc. has announced the acceptance of its abstract submission for the ASCO Gastrointestinal Cancers Symposium 2026, focusing on its innovative targeted oncology therapies and the RenovoCath drug-delivery device [1][4] Company Overview - RenovoRx is a life sciences company specializing in targeted oncology therapies and has developed the FDA-cleared RenovoCath device for drug delivery [7] - The company aims to address high unmet medical needs in cancer treatment through its patented Trans-Arterial Micro-Perfusion (TAMP™) therapy platform [7] Clinical Trial Information - The ongoing Phase III TIGeR-PaC clinical trial evaluates the TAMP therapy platform for treating locally advanced pancreatic cancer (LAPC) [6][10] - A pharmacokinetic and pharmacodynamic sub-study will compare intra-arterial gemcitabine delivered via RenovoCath to standard intravenous chemotherapy [2][3] Presentation Details - The abstract presentation is scheduled for January 9, 2026, at the ASCO GI symposium in San Francisco, with specific time slots for the presentation [4][5] Financial Performance - In the first nine months of 2025, RenovoRx generated approximately $900,000 in revenue from RenovoCath sales, indicating early commercial traction [8] - The company is actively exploring additional revenue-generating activities to meet anticipated demand for its products [9]
RenovoRx’s PanTheR Post-Marketing Registry Study Progresses with First Clinical Procedure and Addition of Two Participating Clinical Sites
Globenewswire· 2025-09-25 12:30
Core Insights - The first registry-eligible patient procedure in the PanTheR Post-Marketing Registry Study has been successfully completed at the University of Vermont Cancer Center, marking a significant milestone for RenovoRx and its RenovoCath device [1][2][3] - Baptist Health Miami Cancer Institute and University of Pittsburgh Medical Center have joined the University of Vermont Cancer Center as participating clinical sites in the PanTheR study, which aims to gather expanded safety and performance data on RenovoCath [2][3] - The PanTheR study is designed to evaluate the long-term safety and survival outcomes for patients with solid tumors treated using RenovoCath, capturing real-world data that may inform future clinical trial designs [5][8] Company Overview - RenovoRx, Inc. is a life sciences company focused on developing innovative targeted oncology therapies and commercializing the RenovoCath device, which is FDA-cleared for targeted drug delivery [7][8] - The RenovoCath device utilizes a patented Trans-Arterial Micro-Perfusion (TAMP™) therapy platform, aiming to improve therapeutic delivery while minimizing toxicities compared to systemic intravenous therapy [8][9] - RenovoRx is also evaluating a novel drug-device combination product candidate, intra-arterial gemcitabine delivered via RenovoCath, in the ongoing Phase III TIGeR-PaC trial [9][10] Study Details - The PanTheR study is a multi-center, post-marketing observational registry study that will collect data on the long-term use and performance of RenovoCath after its FDA clearance [5] - The study aims to generate meaningful real-world data that can guide future treatment decisions for patients with difficult-to-treat cancers, potentially improving survival and quality of life outcomes [4][5] - Participating cancer centers will purchase RenovoCath devices from RenovoRx for use in the study, reinforcing the company's commitment to innovation and patient outcomes [5][11]