Los Altos, CA, November 17, 2022 – RenovoRx, Inc. (Nasdaq: RNXT), a biopharmaceutical company focused on the localized treatment of difficult-to-treat solid tumors through its proprietary RenovoRx Trans-Arterial Micro-Perfusion (RenovoTAMP) therapy platform, today announced RenovoTAMP was highlighted in two presentations delivered at the Advanced Interventional Management Symposium (AIMsymposium). RenovoTAMP is a unique therapy platform designed for targeted intra-arterial (IA) delivery of chemotherapy directly to tumors. This symposium was the 30th annual AIMsymposium and is being held November 14-17, 2022 at the New York Hilton.
Ripal Gandhi, Professor of Interventional Radiology at the Miami Cancer Institute and Miami Cardiac and Vascular Institute, presented “Advances in the Management of Pancreatic Cancer,” and provided an overview of the clinical challenges of the standard-of-care treatment available to locally advanced pancreatic cancer (LAPC) patients. Systemic intravenous (IV) chemotherapy is considered the standard of care for LAPC and is often associated with debilitating side effects and may be ineffective in treating this type of cancer due to tumors lacking dedicated blood vessels critical for delivering chemotherapy.
Dr. Gandhi highlighted the RenovoTAMP therapy platform’s potential as a targeted oncology option for LAPC patients. The presentation reviewed RenovoRx’s RR1 Phase I/II and RR2 Observational Registry studies and RenovoTAMP’s potential to increase chemotherapy delivery directly to the tumor to increase survival and reduce systemic toxicity. Dr. Gandhi also presented the mission and protocol behind the TIGeR-PaC study.
<pstyle=”margin:0;”>The Phase III TIGeR-PaC study is evaluating RenovoRx’s first product candidate, RenovoGem™, to treat LAPC through RenovoTAMP’s intra-arterial delivery of gemcitabine, an FDA-approved chemotherapy. Study goals include the extension of patient survival, reduction of side effects associated with systemic chemotherapy, and improved quality of life for pancreatic cancer patients.
- Christopher Laing, an interventional radiologist at Sutter Medical Group, presented “Animal Studies Using a Double-Balloon Catheter Leads to Interesting Discoveries Regarding the Mechanism of Chemoperfusion for Pancreatic Cancer.” Dr. Laing’s presentation discusses how RenovoTAMP and its potential benefits can be better described and optimized based on important scientific findings using animal models. For example, while some investigators have demonstrated interest in forcing chemotherapy across the wall of the bile duct for the treatment of bile duct cancer, Dr. Laing describes animal experiments that demonstrate challenges to this approach. Dr. Laing further highlights the potential for RenovoTAMP in the bile duct patient population, similar to its use in pancreatic cancer therapy. Dr. Laing also discusses recent discoveries on how the drugs may traverse through the wall of the major blood vessels adjacent to the tumor to make RenovoTAMP work which could also pave the way for expanding the therapy platform to a wide array of therapeutic agents, even beyond small molecule chemotherapeutics.
“The AIMsymposium is an insightful conference that focuses on current issues and new techniques in interventional radiology and endovascular therapy,” said Ramtin Agah, M.D., Chief Medical Officer and Founder of RenovoRx. “We appreciate both Dr. Gandhi and Dr. Laing highlighting our therapy platform and its potential treatment option for patients diagnosed with difficult-to-treat cancers, like pancreatic and bile duct tumors.”
Dr. Agah added, “These presentations emphasize our team’s tremendous focus on refining RenovoTAMP as a potential, more targeted therapy for difficult-to-treat cancers. Results of our studies to date suggest that utilizing approved chemotherapeutics with validated mechanisms of action and well-established safety and side effect profiles via RenovoTAMP has the potential to increase their efficacy, improve safety, and widen therapeutic windows. We continue to push the understanding of the science behind our success. Our research has identified one of the major barriers to therapeutic success in the pancreatic cancer setting: these types of tumors do not have sufficient blood vessels that would normally deliver chemotherapy. The RenovoTAMP therapy may overcome that barrier by using pressure to force chemotherapy into the tissue.”
About the Phase 3 TIGeR-PaC Clinical Trial
TIGeR-PaC is a randomized multi-center Phase III study using RenovoRx’s innovative therapy platform, RenovoTAMP® (RenovoRx Trans-Arterial Micro-Perfusion). The study is evaluating the Company’s first product candidate, RenovoGemTM, to treat locally advanced pancreatic cancer (LAPC) through the intra-arterial delivery of gemcitabine (FDA-approved chemotherapy). The study has a primary endpoint of overall survival and several secondary endpoints, including quality of life.
TIGeR-PaC is currently enrolling unresectable LAPC patients at several sites across the US. To learn more about the study and the participating clinical trial sites, visit https://renovorx.com/clinical-trial/.
About RenovoRx, Inc.
RenovoRx is a clinical-stage biopharmaceutical company with a vision to disrupt the current paradigm of cancer treatment. The company’s 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, thus improving patient well-being and 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 side effect profiles, with the goal of increasing their efficacy, improving their safety, and widening their therapeutic window. RenovoRx’s lead product candidate, RenovoGemTM, 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 trial for the treatment of LAPC.
RenovoRx’s patent portfolio for its therapy platform and product candidates includes seven 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).
Learn more by visiting the RenovoRx website or following RenovoRx on Facebook, LinkedIn and Twitter.
This press release 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 our clinical trials and studies, including anticipated timing, statements regarding the potential of RenovoTAMP®, RenovoCath® or RenovoGemTM or regarding our ongoing TIGeR-PaC Phase III clinical trial in LAPC, and statements regarding the potential for our product candidates to treat or provide clinically meaningful outcomes for certain medical conditions or diseases. 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, clinical trials, therapy platform, business 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 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: the timing of the initiation, progress and potential results of our preclinical studies, clinical trials and our research programs; our ability to use and expand our therapy platform to build a pipeline of product candidates; our ability to advance product candidates into, and successfully complete, clinical trials; the timing or likelihood of regulatory filings and approvals; 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; the commercialization potential of our product candidates, if approved; our ability and the potential to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved; future strategic arrangements and/or collaborations and the potential benefits of such arrangements; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing and our ability to obtain additional capital; the sufficiency of our existing cash and cash equivalents to fund our future operating expenses and capital expenditure requirements; our ability to retain the continued service of our key personnel and to identify, hire and retain additional qualified personnel; the implementation of our strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights, including our therapy platform, product candidates and research programs; our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; the pricing, coverage and reimbursement of our product candidates, if approved; developments relating to our competitors and our industry, including competing product candidates and therapies; negative impacts of the ongoing COVID-19 pandemic on our operations; and other risks. 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.
Shaun R. Bagai, CEO
James Ahlers, CFO
KCSA Strategic Communications
Valter Pinto or Jack Perkins