On April 16, 2024 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, reported a presentation of a clinical data abstract at the recent 2024 Society of Interventional Radiology (SIR) Annual Scientific Meeting, held March 23-27, 2024 in Salt Lake City, Utah (Press release, Renovorx, APR 16, 2024, View Source [SID1234642120]). Clinical data was presented by David Sperling, MD, Associate Professor of Radiology at Columbia University Irving Medical Center in New York.
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Dr. Sperling, together with his co-authors, presented "Mesenteric Venous Thrombosis as a Predictor of Target Artery Thrombosis and Tran-Arterial Micro Perfusion Treatment Completion Among Patients with Locally Advanced Pancreatic Cancer (LAPC)," a sub-study of RenovoRx’s ongoing pivotal Phase III TIGeR-PaC clinical trial. In this sub-study, baseline abdominal CT imaging completed prior to randomization into the TIGeR-PaC study was reviewed for the presence or absence of Mesenteric Venous Thrombosis (MVT) by an independent core imaging radiologist. Outcomes examined 1) patient inability to complete the planned 8 treatments with RenovoRx’s patented Trans-Arterial Micro-Perfusion (TAMP) therapy platform, 2) target vessel thrombosis during or after TAMP, and 3) side effects of pain or discomfort associated with the use of TAMP.
Patients with pancreatic cancer are commonly at risk of both arterial and venous thromboembolism, obstructions of an artery or blood vessel by a blood clot, and MVT can also be an incidental finding when treating this important patient population. MVT is a blood clot impacting one or more of the major veins that drain blood from the intestine that may make certain treatments difficult.
The data presentation highlighted that of the 25 patients randomized to the TAMP therapy, 6 failed to complete all 8 planned procedures due to thrombosis of the targeted arterial artery. Among those 6 patients, the prevalence of MVT on the baseline abdominal CT imaging was 100%.
"Our sub-study presents important data to assist in optimization of TAMP with better risk stratification of patients while improving guidance of TAMP therapy for LAPC treatment," said Dr. Sperling. "After retrospectively evaluating 25 patients randomized to the TAMP therapy in the TIGeR-PaC study, we concluded that MVT on baseline CT imaging is a strong predictor of target artery thrombosis which could be a limitation of TAMP for repeated procedures for these specific patients."
"Identification of the presence of MVT as a risk factor, if addressed clinically, can potentially increase frequency of patients undergoing successful TAMP procedures during treatment with proper management," said Ramtin Agah, MD, Chief Medical Officer and Founder of RenovoRx. "It is important to understand appropriate candidates for TAMP, and managing patients who could be at any risk is paramount to helping underserved patient populations, like those diagnosed with LAPC. This is especially important given the potential of the TAMP therapy platform. The first interim analysis in the Phase III TIGeR-PaC study 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 has a primary endpoint is a 6-month Overall Survival benefit with secondary endpoints including reduced side effects versus standard of care."
TIGeR-PaC (NCT03257033) is currently enrolling unresectable LAPC patients at several sites across the US. To learn more about the study and the participating clinical trial sites, visit www.clinicaltrials.gov. RenovoRx’s first product candidate, RenovoGem, is a novel oncology drug-delivery combination utilizing TAMP administration technology, is currently under investigation for therapeutic delivery of the FDA-approved chemotherapy gemcitabine and has not been approved for commercial sale.
About the Phase III 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, RenovoGem, is a novel oncology drug-delivery combination utilizing TAMP administration technology combined with the FDA-approved chemotherapy, gemcitabine. The study is comparing treatment with TAMP to the current standard of care of systemic intravenous chemotherapy.
About Locally Advanced Pancreatic Cancer (LAPC)
According to American Cancer Society’s Cancer Facts & Figures 2023, pancreatic cancer has a 5-year combined overall survival rate of 13% (Stages I-IV) and is on track to be the second leading cause of cancer-related deaths before 2030. LAPC is diagnosed when the disease has not spread far beyond the pancreas, however, has advanced to the point where it cannot be surgically removed. LAPC is typically associated with patients in Stage 3 of the disease as determined by the TNM (tumor, nodes and metastasis) grading system.
About RenovoGem
RenovoGem is the first drug-device combination product candidate that utilizes the TAMP therapy platform via pressure-mediated delivery technology to deliver gemcitabine, an FDA-approved systemic chemotherapy, locally across the arterial wall to bathe tumor tissue in the chemotherapy. RenovoGem is currently being evaluated in the Phase III TIGeR-PaC clinical trial study in Locally Advanced Pancreatic Cancer (LAPC) patients.
The first interim analysis in the TIGeR-PaC study at the 26th event of the specified events (deaths), was completed in March 2023, with the Data Monitoring Committee recommending a continuation of the study. The TIGeR-PaC study’s primary endpoint is a 6-month OS benefit with secondary endpoints including reduced side effects versus standard of care. The data was first presented at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2023 and then as a Late Breaker Oral Presentation with additional secondary endpoint data at the 2023 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer in June 2023. The second interim analysis for this study will be triggered by the 52nd event, which is estimated to occur in late 2024.