On April 14, 2023 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a biopharmaceutical company focused on the localized treatment of solid tumors, reported that Poster #CT084 is presenting detailed, open label, Phase III TIGeR-PaC study interim data analysis of its innovative RenovoGem therapy for pancreatic cancer patients at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, on Monday, April 17, 2023, at 9:00 AM ET in Orlando, Florida (Press release, Renovorx, APR 14, 2023, View Source [SID1234630103]). AACR (Free AACR Whitepaper) is underway through Wednesday, April 19, 2023.

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The interim analysis shows a 6-month median overall survival benefit for patients with locally advanced pancreatic cancer ("LAPC") which is a 60% improvement over systemic chemotherapy, the current standard of care and study control arm (intravenous (IV) administration of gemcitabine and nab-paclitaxel). RenovoGem patients also demonstrated greater than 65% reduction in adverse events. These can include nausea, fatigue, and a decline in white blood cells.

On Monday, April 17, "Targeted Intra-arterial Gemcitabine vs. Continuation of IV Gemcitabine plus Nab-Paclitaxel following Induction with sequential IV Gemcitabine plus Nab-Paclitaxel and Radiotherapy for Unresectable Locally Advanced Pancreatic Cancer (TIGeR-PaC) – Phase III Trial Interim Analysis," is being presented on Poster #CT084 by Michael Pishvaian, MD, Johns Hopkins Medicine Director of Gastrointestinal, Developmental Therapeutics and Clinical Research Programs, Amer H. Zureikat, MD, Professor of Surgery at the University of Pittsburgh School of Medicine, and other researchers.

This is the first interim analysis of the randomized multi-center Phase III open label TIGeR-PaC clinical trial, designed to investigate the Company’s first product candidate, RenovoGem. In this interim analysis, the control and treatment arms demonstrated divergence in median overall survival for patients. The study is designed to randomize 114 patients (57 in each arm) with all patients receiving upfront induction chemotherapy and stereotactic body radiation therapy (SBRT). The TIGeR-PaC Data Monitoring Committee ("DMC") met and determined the interim data is promising and warrants continuation of this pivotal trial. As of the analysis date, 45 patients from U.S. sites had been randomized in this trial. The survival status of all subjects was used for the analysis.

Twenty-three patients were randomized to intra-arterial gemcitabine (RenovoGem investigational treatment) arm and 22 to continuation of IV gemcitabine and nab-paclitaxel (standard of care control) arm.
The median overall survival in the IV gemcitabine and nab-paclitaxel control arm was 10 months, versus 16 months in the intra-arterial RenovoGem arm from time of randomization. (NOTE: Both arms’ median overall survival calculations do not include 4 to 5-months of life from diagnosis to randomization during the induction chemotherapy and radiation phase of the trial.)
Observed a positive trend in median overall survival by 24-weeks (6 months); in this interim analysis, the statistical significance was not reached to stop the study early (p=0.051).
Observed a 65% reduction in adverse events from control arm to treatment arm.
RenovoRx CEO, Shaun Bagai, commented, "Our RenovoGem therapy has demonstrated the potential to positively change the current standard of care for Locally Advanced Pancreatic Cancer (LAPC). Not only does analysis demonstrate that our therapy may give these patients more time, but it also shows RenovoGem can decrease adverse side effects common with systemic chemotherapy. Our mission is to help patients impacted by difficult-to-treat cancer enjoy better quality of and longer life."

Mr. Bagai added, "We look forward to the TIGeR-PaC researchers presenting this poster at AACR (Free AACR Whitepaper), and continuing strong enrollment with the second interim analysis expected mid to late next year."

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 12% (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 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 RenovoTAMP 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 Company plans to investigate RenovoGem in extrahepatic Cholangiocarcinoma (eCCA) in a clinical trial, which is anticipated to begin in the first half of 2023. RenovoGem is currently under investigation for the intra-arterial delivery of gemcitabine and has not been approved for commercial sale.