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RenovoRx Reports Full Year 2022 Financial Results and Achievement of Important Phase III Clinical Study Milestone
First of Two Planned Interim Analyses Triggered Company and Data Monitoring Committee Conducting Review Results of Analysis Forthcoming LOS ALTOS,
About this update from Renovorx, Inc.
[{"type":"text","content":"\nFirst of Two Planned Interim Analyses Triggered\n\nCompany and Data Monitoring Committee Conducting Review\n\nResults of Analysis Forthcoming\n\n LOS ALTOS, Calif.--(BUSINESS WIRE)--\nRenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a biopharmaceutical company focused on the localized treatment of solid tumors, today is reporting its financial results for the year ended December 31, 2022, and a pipeline update including the status of the interim analysis of for the Company’s Phase III TIGeR-PaC clinical trial.\n\nRenovoRx anticipates finalizing the interim analysis for the TIGeR-PaC Phase III trial and releasing the results within the next week or so. To date, 47 out of 114 target post-SBRT/chemotherapy patients have been randomized in the TIGeR-PaC clinical trial, and the Company has received reports of 26 events (deaths) in this population. This 26th event represents 30% of the 86 events and thus triggered the first planned interim analysis and a meeting of the study’s Data Monitoring Committee (“DMC”) to evaluate the ongoing progression of the Phase III clinical trial. Upon completion of the analysis and assessment of the data by the DMC, and RenovoRx’s subsequent review of their findings, the Company will report the first interim analysis.\n\nTIGeR-PaC is a randomized multi-center Phase III open label clinical trial designed to investigate the Company’s first product candidate, RenovoGemTM, which utilizes RenovoRx’s proprietary therapy platform, RenovoTAMP®, 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 RenovoTAMP 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 have been reported (data announcement forthcoming) and the second analysis when 60% of the events have been reported (expected in 2024).\n\n“RenovoRx has continued to grow in 2022 as we have focused on ...