RenovoRx’s Principal Investigator of Phase III Clinical Trial Discusses Positive Interim Results on Patients with Locally Advanced Pancreatic Cancer on OncologyTube

March 22, 2023 at 09:00 AM EDT

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In the interview, Dr. Michael Pishvaian discussed the trial's potential impact on the oncology community as well as how pancreatic cancer patients are treated. Dr. Pishvaian’s interview with OncologyTube is featured here.

Recently RenovoRx (RNXT) announced interim data in the Phase 3 open-label TIGeR-PaC clinical trial investigating the company's first product candidate, RenovoGem, as a potential treatment option in locally advanced pancreatic cancer (LAPC). The interim analysis suggests a 6-month potential improvement in median overall survival with RenovoGem. The study compares treatment with RenovoTAMP versus standard-of-care systemic intravenous administration of gemcitabine and nab-paclitaxel, which has a seven-week survival benefit and a $1 billion addressable market.

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 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.

About RenovoRx, Inc.

RenovoRx is a clinical-stage biopharmaceutical company with a vision to disrupt the current paradigm of cancer treatment. Our mission is to lead a revolution in oncology therapy by delivering its innovative and targeted intra-arterial (IA) delivery of chemotherapy directly to solid tumors. The proprietary RenovoRx Trans-Arterial Micro-Perfusion (RenovoTAMP^®) therapy platform aims to avoid the harsh side effects typical of the current standard of care, or systemic delivery methods, thus improving patient well-being and, potentially extension of life, so more time may be enjoyed with loved ones. RenovoTAMP utilizes approved chemotherapeutics with validated mechanisms of action and well-established safety and clinical use, with the goal of improving their safety, tolerance, and widening their therapeutic window by providing more targeted delivery at the location of the tumor tissue. RenovoRx’s lead product candidate, RenovoGem^TM, is a combination of gemcitabine and its patented delivery system, RenovoCath^®, and is regulated by the FDA as a novel oncology drug product to treat unresectable locally advanced pancreatic cancer (LAPC). RenovoGem is currently being studied in the Phase III TIGeR-PaC clinical trial for the treatment of LAPC.

RenovoRx’s patent portfolio for its therapy platform and product candidates includes eight issued U.S. patents, one issued European patent, and several additional patents pending in the US, EU and Asia. RenovoRx has been granted Orphan Drug Designation for intra-arterial delivery of gemcitabine for the treatment of both pancreatic cancer and bile duct cancer (cholangiocarcinoma).

Originally published on TalkMarkets

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