Los Altos, CA, May 19, 2022 – RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a biopharmaceutical company and innovator in targeted cancer therapy, today announces that it will present preclinical research supporting its planned second clinical indication, bile duct cancer, also known as cholangiocarcinoma, at the Global Embolization Oncology Symposium Technologies (GEST) 2022, today in New York City. The study demonstrates the potential utility of RenovoRx’s proprietary Trans-Arterial Micro-Perfusion (RenovoTAMPTM) therapy platform for the treatment of cholangiocarcinoma.
Cholangiocarcinoma is a rare and aggressive cancer that forms in the bile ducts — thin tubes that carry a digestive fluid, called bile, from the liver to other digestive organs. Most people with cholangiocarcinoma do not have symptoms until the disease becomes more advanced, making early diagnoses difficult. Like pancreatic cancer, which the Company is evaluating in a Phase 3 study, bile duct tumors that grow outside of the liver lack tumor feeder blood vessels, which provide a pathway between the blood stream and the tumor. Tumor feeders are critical to the effectiveness of systemic chemotherapy. Published research supports that without direct access to the tumor, systemic chemotherapy circulates through the body, without a significant amount of chemotherapy reaching the tumor.
RenovoRx plans to launch a Phase 2/3 study in cholangiocarcinoma in the second half of 2022. The Company also received Orphan Drug Designation for this clinical indication in April 2021.
“We are pleased to present our preclinical research data studying RenovoTAMP’s utility in cholangiocarcinoma at this peer-reviewed, scientific meeting – GEST 2022,” said Dr. Ramtin Agah, Chief Medical Officer and Co-Founder at RenovoRx. “To be effective, chemotherapy must be able to reach the tumor. RenovoTAMP was designed to bring the chemotherapy to the tumor when there is no other pathway available. Through localized delivery of chemotherapy, we are hoping to provide a more effective treatment option for cancer patients, reduce the debilitating side effects typical of standard of care systemic chemotherapy and improve patient survival for cancers like cholangiocarcinoma.”
The purpose of the preclinical study was to compare the effectiveness of delivery of a chemotherapeutic agent inside the bile duct via the gall bladder versus intra-arterially, into the tissue surrounding the bile duct (RenovoTAMP). This study determined that delivery via the gallbladder resulted in zero tissue penetration. In comparison, intra-arterial delivery resulted in extensive tissue penetration, confirming the Company’s plan to utilize RenovoTAMP in its planned Phase 2 study.
The abstract and poster for the study, “Localized Delivery of Chemotherapy Through the Bile Duct Using a Double Balloon Catheter in A Porcine Model,” are available on RenovoRx’s website: https://renovorx.com/for-clinicians/.
RenovoTAMP is currently being investigated in the Phase 3 TIGeR-PaC clinical trial as a potential treatment option for patients with unresectable locally advanced pancreatic cancer. RenovoRx received Orphan Drug Designation for pancreatic cancer in 2018.
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, statements regarding the potential of RenovoTAMPTM or regarding our ongoing TIGeR-PaC Phase 3 clinical trial in locally advanced pancreatic cancer, and planned Phase 2/3 clinical trial in cholangiocarcinoma; 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 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
Christopher J. Lehman, CFO