Publication of Results of Pre-Clinical Studies Support Efficacy and Drug Delivery Mechanism Potential of RenovoRx's TAMP™ Therapy Platform to Improve Targeted Cancer Drug Treatment Delivery
Data shows that the Trans-Arterial Micro-Perfusion (TAMP) platform increases intra-arterial pressure, improving drug delivery with 100-fold increase local tissue concentration of the therapy
TAMP offers the potential to increase efficacy, improve safety and widen therapeutic window of drugs or other agents
RenovoRx, Inc. ("RenovoRx" or the "Company") (NASDAQ:RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, today announced a publication of pre-clinical studies supporting the efficacy and drug delivery mechanism of RenovoRx's Trans-Arterial Micro-Perfusion ("TAMP") therapy platform. The data was published online in the peer-reviewed Journal of Vascular Interventional Radiology("JVIR") journal and will also be published in the print version.
The manuscript is authored by Khashayar Farsad, MD, PhD of the Department of Interventional Radiology at Oregon Health and Science University, and co-authored by Paula M. Novelli, MD, of the University of Pittsburgh Hillman Cancer Center, together with other researchers, including RenovoRx's Chief Medical Officer, Dr. Ramtin Agah. Access the JVIR abstract: https://pubmed.ncbi.nlm.nih.gov/38508449/.
Currently, most cancer patients with solid tumors receive chemotherapy intravenously, meaning it is introduced systemically into the entire body and causes well known adverse side effects. RenovoRx's patented TAMP therapy platform is designed to bypass traditional systemic delivery methods and provide precise delivery to bathe the target solid tumor in chemotherapy. This precise delivery also creates the potential to minimize a therapy's systemic toxicities.
The pre-clinical data published in JVIR showed a 100-fold (two orders of magnitude) increase in local tissue concentration of the therapy with TAMP compared to conventional intravenous (IV) delivery. TAMP also showed advantages compared to historically available intra-arterial (IA) delivery approaches. TAMP's novel approach to treatment offers the potential to increase an oncology therapy's efficacy, improve safety, and widen its therapeutic window by focusing its distribution uniformly in target tissue.
"TAMP has the potential to provide a valuable treatment option to patients who have been diagnosed with solid tumors that may be difficult-to-treat," said Dr. Farsad. "The study shows a possible mechanism for how TAMP can increase local therapeutic tissue concentration in solid tumors that is independent from traditional catheter-directed therapy. We are awaiting final outcomes of the Phase III clinical trial, currently underway, to validate this benefit."
Dr. Farsad adds, "This platform has the potential to extend across a variety of unmet needs for localized therapeutic drug delivery."
About the Phase III TIGeR-PaC Clinical Trial
TIGeR-PaC is RenovoRx's ongoing Phase III randomized multi-center study evaluating the proprietary TAMP therapy platform for the treatment of Locally Advanced Pancreatic Cancer (LAPC.) RenovoRx's first product candidate, RenovoGem™, is a novel oncology drug-delivery combination utilizing TAMP administration technology combined with the FDA-approved chemotherapy, gemcitabine. The TIGeR-PaC study is comparing treatment with TAMP to systemic intravenous chemotherapy, the current standard of care.
The first interim analysis in the TIGeR-PaC study occurred at the 26th event of the specified events (deaths), and was completed in March 2023, with the Data Monitoring Committee recommending a continuation of the study. The TIGeR-PaC study's primary endpoint is a 6-month Overall Survival (OS) benefit with secondary endpoints including reduced side effects versus standard of care.
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 13% (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 the 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 RenovoRx, Inc.
RenovoRx is a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a proprietary local drug-delivery platform for high unmet medical need with a goal to improve therapeutic outcomes for cancer patients undergoing treatment. RenovoRx's patented Trans-Arterial Micro-Perfusion (TAMP™) therapy platform is designed to ensure precise therapeutic delivery to directly target the tumor while potentially minimizing a therapy's toxicities versus systemic intravenous therapy. RenovoRx's novel and patented approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy. Our Phase III lead product candidate, RenovoGem™, a novel oncology drug-device combination product, is being investigated under a U.S. investigational new drug application that is regulated by the FDA's 21 CFR 312 pathway. RenovoGem is currently being evaluated for the treatment of locally advanced pancreatic cancer by the Center for Drug Evaluation and Research (the drug division of FDA.)
RenovoRx is committed to transforming the lives of patients by delivering innovative solutions to change the current paradigm of cancer care. RenovoGem is currently under investigation for TAMP therapeutic delivery of gemcitabine and has not been approved for commercial sale.
For more information, visit www.renovorx.com. Follow RenovoRx on Facebook, LinkedIn, and Twitter.
Cautionary Note Regarding Forward-Looking Statements
This press release and statements of the Company's management made in connection therewith contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934, including but not limited to statements regarding (i) our clinical trials and studies, including anticipated timing, statements regarding the potential of RenovoCath®, RenovoGem™ or TAMP™ or regarding our ongoing TIGeR-PaC Phase III clinical trial study in LAPC, (ii) the potential for our product candidates to treat or provide clinically meaningful outcomes for certain medical conditions or diseases and (iii) our efforts to expand our intellectual property. Statements that are not purely historical are forward-looking statements. The forward-looking statements contained herein are based upon our current expectations and beliefs regarding future events, many of which, by their nature, are inherently uncertain, outside of our control and involve assumptions that may never materialize or may prove to be incorrect. These may include estimates, projections and statements relating to our research and development plans, intellectual property development, clinical trials, our therapy platform, business plans, financing plans, objectives and expected operating results, which are based on current expectations and assumptions that are subject to known and unknown risks and uncertainties that may cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These statements may be identified using words such as "may," "expects," "plans," "aims," "anticipates," "believes," "forecasts," "estimates," "intends," and "potential," or the negative of these terms or other comparable terminology regarding RenovoRx's expectations strategy, plans or intentions, although not all forward-looking statements contain these words. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, that could cause actual events to differ materially from those projected or indicated by such statements, including, among other things: (i) the risk that the pre-clinical data described herein may not provide any future benefits to the Company; (ii) circumstances which would adversely impact our ability to efficiently utilize our cash resources on hand or raise additional funding, (iii) the timing of the initiation, progress and potential results (including the results of interim analyses) of our preclinical studies, clinical trials and our research programs; (iv) the possibility that interim results may not be predictive of the outcome of our clinical trials, which may not demonstrate sufficient safety and efficacy to support regulatory approval of our product candidate, (v) that the applicable regulatory authorities may disagree with our interpretation of the data; research and clinical development plans and timelines, and the regulatory process for our product candidates; (vi) future potential regulatory milestones for our product candidates, including those related to current and planned clinical studies; (vii) our ability to use and expand our therapy platform to build a pipeline of product candidates; (viii) our ability to advance product candidates into, and successfully complete, clinical trials; (ix) the timing or likelihood of regulatory filings and approvals; (x) our estimates of the number of patients who suffer from the diseases we are targeting and the number of patients that may enroll in our clinical trials; (xi) the commercialization potential of our product candidates, if approved; (xii) our ability and the potential to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved; (xiii) future strategic arrangements and/or collaborations and the potential benefits of such arrangements; (xiv) our estimates regarding expenses, future revenue, capital requirements and needs for additional financing and our ability to obtain additional capital; (xv) the sufficiency of our existing cash and cash equivalents to fund our future operating expenses and capital expenditure requirements; (xvi) our ability to retain the continued service of our key personnel and to identify, and hire and retain additional qualified personnel; (xvii) the implementation of our strategic plans for our business and product candidates; (xviii) the scope of protection we are able to establish and maintain for intellectual property rights, including our therapy platform, product candidates and research programs; (xix) our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; (xx) the pricing, coverage and reimbursement of our product candidates, if approved; and (xxi) developments relating to our competitors and our industry, including competing product candidates and therapies. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in documents that we file from time to time with the Securities and Exchange Commission.
Forward-looking statements included herein are made as of the date hereof, and RenovoRx does not undertake any obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as required by law.
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