On December 13, 2023 RenovoRx, Inc. (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, reported that the Company has filed an international patent application under the Patent Cooperation Treaty (PCT) for its novel Trans-Arterial Micro-Perfusion (TAMP) therapy platform (Press release, Renovorx, DEC 13, 2023, View Source [SID1234638546]). The Company already holds a strong intellectual property portfolio with 9 issued patents and 9 pending patents for its proprietary TAMP platform and delivery system in the US, EU, and Asia. The patent portfolio covers two main areas, mechanical and biological.
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The new international patent application is filed under the Patent Cooperation Treaty on methods and apparatuses that may be used to deliver one or more therapeutic agents through the vaso vasorum (small blood vessels that supply the walls of larger arteries or veins) to a target tissue. RenovoRx believes that these methods and apparatuses via the TAMP therapy platform may provide a novel and important pathway for the targeted delivery of therapeutic classes across DNA/RNA-altering modalities, cell therapy, oncolytic viruses, bi-specific antibodies, and monoclonal antibodies for the treatment of a variety of clinical indications. The Company anticipates that the patent application will be published in May of 2024.
"This patent application further expands the value of TAMP into the delivery of larger therapeutic assets, as a unique platform in oncology, beyond our current Phase III clinical asset," said Shaun Bagai, CEO, RenovoRx. "Once approved, it will further extend our IP coverage, opening up new market potential, expanding the upside value proposition of TAMP commercially. We look forward to providing further highlights and updates related to this patent, as well as our progress in our Phase III TIGeR-PaC clinical program."
TAMP is being investigated in the Company’s Phase III TIGeR-PaC clinical trial, an ongoing randomized multi-center study. The study is evaluating trans-arterial delivery of an FDA-approved chemotherapy, gemcitabine, to treat Locally Advanced Pancreatic Cancer (LAPC) following stereotactic body radiation therapy (SBRT). The study is comparing treatment of gemcitabine with TAMP versus systemic IV administration of gemcitabine and nab-paclitaxel.
The first of two interim analyses was completed in March 2023, and the Data Monitoring Committee (DMC) recommended a continuation of the study. The study is prespecified to provide a primary endpoint of a 6-month Overall Survival benefit and secondary endpoints including reduced side effects versus standard of care.