Los Altos, CA, January 6, 2022 – RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a biopharmaceutical company and innovator in targeted cancer therapy, today announced that Dr. Ripal Gandhi, M.D., FSIR, FSVM, a Principal Investigator in the Company’s Phase 3 TIGeR-PaC study, presented ‘Transarterial Treatment Option in Pancreas Cancer’ at the recent 2022 SPECTRUM Conference. Dr. Gandhi is professor of Interventional Radiology at the Miami Cancer Institute and Miami Cardiac and Vascular Institute, Florida International University Herbert Wertheim College of Medicine. The 2022 SPECTRUM conference was held last weekend, January 14-16, 2022, at the Nobu Hotel in Miami Beach, Florida.
Since 2018, Dr. Gandhi has played a pivotal role in the TIGeR-PaC clinical trial as the PI for the Miami Cancer Institute. The TIGeR-PaC study is evaluating the Company’s novel therapy platform, RenovoTAMP (RenovoRx Trans-Arterial Micro-Perfusion) as a potential treatment option for locally advanced pancreatic cancer (LAPC) that may extend patient survival, reduce the typical, often debilitating side-effects associated with systemic chemotherapy (delivered intra-venously), and ultimately improve quality of life for pancreatic cancer patients.
Dr. Gandhi’s presentation at the 2022 SPECTRUM Conference provides an overview of the RenovoTAMP platform and supportive published research. The presentation showcased RenovoRx’s RR1 Phase I/II and RR2 Observational Registry studies that suggests that when RenovoTAMP is used in combination with radiation therapy, arterial microvasculature may be reduced, thereby minimizing chemotherapy leakage during delivery, and increasing the chemotherapy directly reaching the tumor – resulting in targeted delivery and reduced systemic side effects. In addition, Dr. Gandhi also shared preliminary pharmacokinetic data (data describing the absorption, distribution, metabolism, and excretion of chemotherapy) from five patients in the TIGeR-PaC study, which demonstrates an approximate two-thirds reduction in systemic gemcitabine, when compared to systemic levels in historical control patients receiving traditional IV infusion of gemcitabine. This data suggests that by using RenovoTAMP for targeted delivery of chemotherapy, the systemic impacts of chemotherapy may be being reduced.
“We appreciate Dr. Gandhi, a recognized expert specializing in minimally invasive treatments for cancer, both in his role as a Principal Investigator for the TIGeR-PaC study supporting our patients and their families, and for his ongoing efforts to educate clinicians throughout the medical community on the potential for RenovoTAMP as an option for the treatment of their patients with LAPC, ” stated Dr. Ramtin Agah, Chief Medical Officer and Co-Founder of RenovoRx. He continued, “Our foundational studies provided support for the potential for intra-arterial delivery via RenovoTAMP to improve patient survival and counter the tolerability issues inherent to chemotherapy, which improves quality of life for patients during this critical time. Our team continues to make progress enrolling our Phase 3 clinical trial and looks forward to reporting on the interim data read out.”
About the 2022 SPECTRUM Conference
The SPECTRUM conference offers attendees a comprehensive review of a variety of oncological diseases, combined with the latest developments in medical, interventional and surgical therapeutic options across multiple disciplines. SPECTRUM is both didactic and interactive with panel discussions, instructive case presentations and hands-on workshops focused on hepatocellular carcinoma, lung cancer, metastatic colorectal cancer, cholangiocarcinoma and liver metastases, renal and prostate cancer, pancreatic cancer, neuroendocrine and musculoskeletal tumors.
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 Phase 1 (RR1) and Observational Registry (RR2) studies, 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 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
KCSA Strategic Communications
Valter Pinto or Jack Perkins