The accepted abstracts support RenovoRx’s lead oncology product candidate, RenovoGem™, and its novel therapy platform, RenovoTAMP®, for the treatment of difficult-to-treat cancers.
Los Altos, CA, December 15, 2022 – RenovoRx, Inc. (Nasdaq: RNXT), a biopharmaceutical company focused on the localized treatment of difficult-to-treat solid tumors, today announced the acceptance of four clinical data abstracts supporting its lead oncology product candidate, RenovoGem, and its proprietary RenovoRx Trans-Arterial Micro-Perfusion (RenovoTAMP) therapy platform to be presented at the 2023 ASCO Gastrointestinal Cancers Symposium (ASCO GI). The Symposium is to be held on January 19-21, 2023 in San Francisco, California and online.
RenovoGem (gemcitabine, an FDA-approved chemotherapy, delivered via the Company’s proprietary delivery system), utilizes pressure mediated delivery of drug across the arterial wall to bathe tumor tissue in chemotherapy via RenovoTAMP. RenovoGem is currently being evaluated in a Phase III clinical trial in Locally Advanced Pancreatic Cancer (LAPC) patients and the Company plans to investigate RenovoGem in extrahepatic Cholangiocarcinoma (eCCA), beginning in the first half of 2023.
“These research presentations will mark the beginning of a significant year at RenovoRx,” said Shaun Bagai, CEO of RenovoRx. “We anticipate continued strong progress on the TIGeR-PaC study with our most significant milestone to date: the first prospective interim analysis of TIGeR-PaC. We also plan to launch a clinical program in extrahepatic Cholangiocarcinoma (bile duct cancer), the second clinical indication for RenovoGem and the RenovoTAMP platform.”
“We are excited to present clinical research data generated by some of our investigators of the TIGeR-PaC study at ASCO GI,” said Ramtin Agah, MD, Chief Medical Officer and Founder of RenovoRx. “These abstracts cover topics relevant to treatment of patients participating in the TIGeR-PAC study. Furthermore, we will also share data regarding the difference in systemic level of gemcitabine using our therapy platform versus the conventional treatment approach for LAPC which is central to our goal of presumed increased efficacy for RenovoTAMP with less systemic side effects.”
Poster Presentations Details
Title: Incidence and Clinical Characteristics of Patients with Locally Advanced Pancreatic Cancer (LAPC) and Mesenteric Vein thrombosis and Current Treatment Paradigm
Authors: Amer H. Zureikat, MD, et al.
Abstract ID: 392418
Title: Intra-arterial Gemcitabine vs IV Gemcitabine PK Sub-study in Patients with Locally Advanced Pancreatic Cancer
Authors: Amer H. Zureikat, MD, et al.
Abstract ID: 394254
Title: Toxicity and Efficacy of Stereotactic Body Radiation Therapy vs. Intensity-modulated Radiation Therapy for the Treatment of Locally Advanced Pancreatic Cancer in a Phase III Trial
Authors: Karyn A. Goodman, MD, et al.
Abstract ID: 392402
Title: Targeted Intra-arterial Gemcitabine vs. Continuation of IV Gemcitabine Plus Nab-paclitaxel Following Induction with Sequential IV gemcitabine Plus Nab-paclitaxel and Radiotherapy for Unresectable Locally Advanced Pancreatic Cancer (TIGeR-PaC): A Randomized Phase III Multi-Center Study (Clinical Trials in Progress)
Authors: Michael J. Pishvaian, MD, et al.
Abstract ID: 393234
About the Phase III 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).
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