Committed to Transforming the lives of patients by delivering innovative solutions to change the current paradigm of cancer care.
Pipeline: Targeted Drug Delivery via TAMP and RenovoCath in Additional Potential Clinical Indications
Beyond locally advanced pancreatic cancer (LAPC), we believe there are many clinical applications (see below) for TAMP to improve targeted delivery of diagnostic and therapeutic agents.
While the oncology field has made progress with the treatment of cancers over the past few decades, the limited effectiveness of chemotherapy accompanied by debilitating side effects remains a barrier to standard of care treatment. The common objective in chemotherapy treatment innovation is to enhance dosing of the drug, while minimizing systemic toxicity. The standard of care for most cancers is systemic (intravenous) chemotherapy, which delivers chemotherapy throughout the body.
Our proprietary Trans-Arterial Micro-Perfusion (TAMP™) therapy platform is designed to ensure targeted therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor, while potentially minimizing a therapy’s toxicities versus systemic intravenous therapy. TAMP is enabled by our patented, FDA-cleared RenovoCath device. RenovoCath is indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. RenovoRx’s novel approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy.
Within the Phase III TIGeR-PaC trial, we are evaluating a novel drug-device combination oncology product candidate (intra-arterial gemcitabine, known as IAG), which is enabled by RenovoCath, in LAPC. IAG is being evaluated by the Center for Drug Evaluation and Research (the drug division of FDA) under a U.S. investigational new drug application that is regulated by the FDA’s 21 CFR 312 pathway. The combination product candidate, enabled the RenovoCath device, is currently under investigation and has not been approved for commercial sale.
The investigational drug-device combination candidate utilizes RenovoCath®, the Company’s FDA-cleared drug-delivery device, indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. The intra-arterial infusion of gemcitabine by RenovoCath is currently being evaluated for the treatment of LAPC by the Center for Drug Evaluation and Research (the drug division of FDA).
The TAMP therapy platform is currently being evaluated in the Phase III TIGeR-PaC clinical trial in LAPC. Beyond LAPC, we believe there are many clinical applications for RenovoCath and TAMP to improve targeted delivery of agents. We are now commercializing RenovoCath. Additionally, our combination oncology drug-device product candidate received FDA Orphan Drug Designation for pancreatic cancer and bile duct cancer which provides 7 years of market exclusivity upon New Drug Application approval.
1 https://seer.cancer.gov/statfacts/html/pancreas.html
2 https://pmc.ncbi.nlm.nih.gov/articles/PMC4746088/
3 https://journals.lww.com/cmj/Fulltext/2022/03050/Cancer_statistics_in_China_and_United_States,.11.aspx
4 https://journals.lww.com/cmj/Fulltext/2022/03050/Cancer_statistics_in_China_and_United_States,.11.aspx
5 https://seer.cancer.gov/statfacts/html/lungb.html
6 https://pmc.ncbi.nlm.nih.gov/articles/PMC10047909/
7 https://seer.cancer.gov/statfacts/html/brain.html
8 https://www.ncbi.nlm.nih.gov/books/NBK470003/
9 https://seer.cancer.gov/statfacts/html/corp.html
10 https://journals.lww.com/cmj/Fulltext/2022/03050/Cancer_statistics_in_China_and_United_States,.11.aspx
11 https://www.cancer.org/cancer/types/soft-tissue-sarcoma/about/key-statistics.html