On June 1, 2023 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing targeted combination therapies, reported that the University of Texas (UT) Southwestern Medical Center is now enrolling pancreatic cancer patients in the open label, randomized Phase III TIGeR-PaC clinical trial (Press release, Renovorx, JUN 1, 2023, View Source [SID1234632376]). The study is investigating RenovoGem which utilizes RenovoRx’s proprietary therapy platform, TAMP, to provide improved and targeted intra-arterial delivery of FDA-approved gemcitabine chemotherapy to treat Locally Advanced Pancreatic Cancer (LAPC).
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The study is comparing RenovoGem with standard of care treatment (intravenous gemcitabine and nab-paclitaxel). RenovoRx recently announced interim analysis data that suggested a 6-month improvement in median overall survival and a 65% reduction in side effects versus standard of care.
"Pancreatic cancer is expected to be the second largest cause of cancer-related deaths before 2030*," said Principal Investigator, Salwan Al Mutar, MD, MSc, Assistant Professor at UT Southwestern Medical Center. "Systemic, intra-venous chemotherapy uses blood vessels to deliver treatment. However, pancreatic cancer tumors have poor blood supply so systemic chemotherapy may not reach the tumor. This clinical trial is evaluating targeted, intra-arterial chemotherapy that is singularly focused on the tumor."
Ramtin Agah, M.D., RenovoRx’s Founder and Chief Medical Officer, commented, "UT Southwestern Medical Center is one of the world’s premier academic medical organizations, integrating research with exceptional clinical care. We are excited Dr. Al Mutar and his team are enrolling patients in this important and transformative study. Our shared vision is providing cancer patients with novel therapies to enhance survival and quality of life."
UT Southwestern is the most recent clinical trial site to join the Phase III TIGeR-PaC study which continues enrolling patients at U.S. sites. UT Southwestern’s staff of more than 2,800 providers is responsible for groundbreaking medical advances and is committed to translating science-driven research quickly to new clinical treatments. Physicians there provide medical care in about 80 specialties to more than 105,000 hospitalized patients, nearly 370,000 emergency room cases and oversee approximately three million outpatient visits annually.
About the TIGeR-PaC Study
TIGeR-PaC is a randomized multi-center Phase III open label clinical trial designed to investigate the Company’s first product candidate, RenovoGem, which utilizes RenovoRx’s proprietary therapy platform, TAMP, to provide targeted intra-arterial delivery of FDA-approved chemotherapy, gemcitabine, to treat locally advanced pancreatic cancer (LAPC) following stereotactic body radiation therapy (SBRT). The study is comparing treatment with TAMP versus standard of care systemic intravenous (IV) administration of gemcitabine and nab-paclitaxel. The study is designed to randomize 114 patients (57 in each arm) with all patients receiving upfront induction chemotherapy and SBRT. Final analysis will be conducted after 86 protocol-specified events have occurred in the SBRT population with two planned interim analyses: the first analysis when 30% of the specified events has been reported and the second analysis when 60% of the events have been reported (expected in mid-2024).
TIGeR-PaC 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 View Source