Los Altos, CA, September 28, 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 Ripal Gandhi, M.D., FSIR, FSVM presented, “Trans-Arterial Micro-Perfusion Therapy for Pancreatic Cancer,” at the recent Symposium on Clinical Interventional Oncology (CIO). Dr. Gandhi is a course director for the symposium recently held September 23-25, 2022 at the Loews Hotel in Miami Beach, Florida. View Dr. Gandhi’s full presentation here.
Dr. Gandhi is a professor of Interventional Radiology at the Miami Cancer Institute and Miami Cardiac and Vascular Institute, Florida International University Herbert Wertheim College of Medicine. Since 2018, Dr. Gandhi has been instrumental in the multi-center Phase 3 TIGeR-PaC clinical trial as a principal investigator for the Miami Cancer Institute.
Dr. Gandhi’s presentation, “Trans-Arterial Micro-Perfusion Therapy for Pancreatic Cancer,” provides an overview of the clinical challenges of the standard-of-care treatment, available to locally advanced pancreatic cancer (LAPC) patients. Systemic (intravenous) chemotherapy is considered the standard of care for LAPC and is often associated with debilitating side effects. It 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 showcased RenovoRx’s RR1 Phase I/II and RR2 Observational Registry studies suggesting when RenovoTAMP is used in combination with radiation therapy, arterial microvasculature may be reduced, minimizing chemotherapy leakage during delivery. Increasing chemotherapy directly to the tumor could reduce systemic side effects. Dr. Gandhi also presented about the mission and protocol behind the TIGeR-PaC study.
The 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 extension of patient survival, reduction of side-effects associated with systemic chemotherapy, and improved quality of life for pancreatic cancer patients.
“The CIO symposium aims to educate on the most viable and sought-after treatments in the rapidly growing practice of interventional oncology management,” said Ramtin Agah, M.D., Chief Medical Officer and Founder of RenovoRx. “As a recognized expert in this field, we appreciate Dr. Gandhi highlighting our therapy platform as a potential option for difficult-to-treat cancers, like LAPC.”
“Over the past decade, our team has refined RenovoTAMP. Results of Phase 1/2 and observational registry studies suggest RenovoTAMP may enhance patient survival while countering chemotherapy tolerability issues. The result could be improved quality of life for patients and their loved ones. Our team continues making progress enrolling the TIGeR-PaC study. We look forward to reporting the first prospective interim analysis for the study, which is expected in the fourth quarter of this year.”
About RenovoRx, Inc.
RenovoRx is a clinical-stage biopharmaceutical company focused on fighting cancer through the localized treatment of difficult to treat tumors via its proprietary RenovoRx Trans-Arterial Micro-Perfusion (RenovoTAMPTM) therapy platform. 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 our 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 3 TIGeR-PaC trial for the treatment of LAPC.
RenovoRx’s patent portfolio includes seven U.S. patents for its technology. RenovoRx has been granted Orphan Drug Designation for intra-arterial delivery of gemcitabine for the treatment of both pancreatic cancer and bile duct cancer.
RenovoRx won the Drug Delivery Technology category of the Fierce Innovation Awards – Life Sciences Edition 2020 for its RenovoTAMP technology.
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 RenovoTAMPTM, RenovoCath® or RenovoGemTM or regarding our ongoing TIGeR-PaC Phase 3 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