RenovoRx Publishes Positive Early Clinical Data in The Oncologist

Published data indicates that chemotherapy administered via TAMP™ post-chemoradiation in patients with Locally Advanced Pancreatic Cancer (LAPC) showed an Overall Survival (OS) of 27 months. Targeted chemotherapy through TAMP is presently under investigation in a Phase III clinical trial for LAPC. 

RenovoRx, Inc., a biopharmaceutical company in its clinical stage developing precision oncology therapies through a local drug delivery platform, announced positive early-stage clinical data about its Trans-Arterial Micro-Perfusion (TAMP) therapy. This information was published in The Oncologist, an international peer-reviewed journal. The article, "Treatment of Locally Advanced Pancreatic Cancer (LAPC) Using Localized Trans-Arterial Micro Perfusion (TAMP) of Gemcitabine: Combined Analysis of RR1 and RR2," primarily discusses the safety, overall survival (OS), and factors associated with OS in LAPC patients treated with TAMP from foundational studies by RenovoRx.

The studies used intra-arterial gemcitabine administration through the TAMP platform in an early Phase I/II dose escalation safety study (RR1) and post-treatment data from an observational registry study (RR2). The lead author, Dr. Hassan Hatoum, an oncologist and hematologist from the University of Oklahoma Health Sciences Center (OUHSC), remarked on the potential advancement in cancer treatment standards with reduced toxicity and improved outcomes. He noted that the data supports TAMP's capability to extend OS compared to systemic chemotherapy in challenging solid tumors, offering a new treatment paradigm for LAPC patients.

TAMP leverages the RenovoCath® device, cleared by the FDA for various uses, including arteriography, preoperative occlusion, and drug infusion. Currently, it is being evaluated in a Phase III trial, comparing its intra-arterial chemotherapy delivery to the standard systemic intravenous method for LAPC treatment. The published article can be found in The Oncologist journal.

TAMP aims to bypass traditional systemic delivery of chemotherapy, allowing precise delivery through the artery near the tumor site, thereby bathing the tumor in chemotherapy while minimizing systemic toxicities. RR1 and RR2 studies addressed the unmet medical need for a more effective locoregional LAPC therapy to improve survival and increase cancer resectability. Data analysis pooled from RR1 and RR2 aimed to assess TAMP's procedural safety, OS, and factors influencing OS. For 35 evaluable LAPC patients, the median OS was 12.6 months. TAMP-delivered chemotherapy in patients with prior radiation showed a significantly longer OS (27.1 months) compared to those who had prior systemic chemotherapy (14.6 months) or no prior treatment (7.0 months). Common side effects included gastrointestinal issues, with the most frequent Grade 3 toxicity being sepsis. The study concluded that TAMP-mediated drug delivery in LAPC patients is potentially safe, feasible, and beneficial clinically.

Dr. Ramtin Agah, Chief Medical Officer and Founder of RenovoRx, highlighted that current FDA-approved treatments for pancreatic cancer offer less than a two-month median survival benefit but with increased toxicity. The significant survival benefit and lower side effects of TAMP compared to the current standard of care suggest that TAMP could be a promising treatment for pancreatic and other hard-to-treat cancers. The article consolidates findings from RR1 and RR2 studies, forming the basis for the ongoing Phase III TIGeR-PaC trial. This study aims to validate TAMP's benefits compared to systemic chemotherapy.

RenovoRx is a clinical-stage biopharmaceutical company developing innovative precision oncology therapies to address high unmet medical needs, aiming to improve therapeutic outcomes for cancer patients. The company's TAMP platform ensures precise therapeutic delivery to target tumors while potentially reducing toxicities associated with systemic therapies. RenovoGem™, an investigational product under the TAMP platform, is being evaluated for LAPC treatment. RenovoRx is also considering expanding TAMP's application to other cancers and exploring commercialization strategies for its technology.

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