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RenovoRx Begins Patient Enrollment at UT Southwestern Medical Center for Pivotal Phase III TIGeR-PaC Clinical Trial

Study is investigating RenovoGem™ as a potential new option for the treatment of pancreatic cancer A recent positive interim analysis of study data revealed a 60% survival benefit and 65% reduction in side effects compared to systemic chemotherapy

RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing targeted combination therapies, today announced that the University of Texas (UT) Southwestern Medical Center is now enrolling Pancreatic cancer patients in the open-label, randomized Phase III TIGeR-PaC clinical trial. The study is investigating RenovoGem, which uses RenovoRx’s proprietary therapy platform, TAMP™, to provide enhanced and targeted intra-arterial delivery of FDA-approved gemcitabine chemotherapy to treat locally advanced pancreatic cancer (LAPC).

The study compares RenovoGem with standard treatment (intravenous gemcitabine and nab-paclitaxel). RenovoRx recently announced interim analysis data suggesting a 6-month improvement in median overall survival and a 65% reduction in side effects compared to standard treatment.

“Pancreatic cancer is expected to be the second leading cause of cancer-related deaths by 2030*,” said lead investigator Salwan Al Mutar, MD, MSc, assistant professor at UT Southwestern Medical Center. “Systemic intravenous chemotherapy uses blood vessels to deliver treatment. However, pancreatic cancer tumors have a poor blood supply, so systemic chemotherapy may not reach the tumor. This clinical trial is evaluating targeted intra-arterial chemotherapy that is singularly focused on the tumor.”

Ramtin Agah, MD, founder and chief medical officer of RenovoRx, commented, “UT Southwestern Medical Center is one of the world’s leading academic medical organizations, integrating research with exceptional clinical care. We are excited that Dr. Al Mutar and his team are enrolling patients in this important and life-changing study. Our shared vision is to provide cancer patients with novel therapies to improve survival and quality of life.”

UT Southwestern is the newest clinical trial site to join the Phase III TIGeR-PaC study that continues to enroll patients at US sites. UT Southwestern’s staff of more than 2,800 providers is responsible for innovative medical advances and is committed to rapidly translating science-driven research into new clinical treatments. Physicians provide care in about 80 specialties to more than 105,000 hospitalized patients, nearly 370,000 emergency room cases, and oversee approximately three million outpatient visits annually.

About the TIGeR-PaC Study

TIGeR-PaC is an open-label Phase III randomized multicenter clinical trial designed to investigate the company’s first product candidate, RenovoGem™, which uses RenovoRx’s proprietary therapy platform, TAMP™, to provide targeted intra-arterial delivery of FDA-approved chemotherapy. FDA approved gemcitabine to treat locally advanced pancreatic cancer (LAPC) after stereotactic body radiation therapy (SBRT). The study compares TAMP treatment versus standard systemic intravenous (IV) administration of gemcitabine and nab-paclitaxel. The study is designed to randomize 114 patients (57 in each arm) with all patients receiving initial induction chemotherapy and SBRT. The final analysis will be performed after 86 protocol-specified events have occurred in the SBRT population with two interim analyzes planned: the first analysis when 30% of the specified events have been reported and the second analysis when 60% have been reported. % of events (expected for mid-2024).

TIGeR-PaC is currently enrolling unresectable LAPC patients at multiple sites in the US. For more information about the study and participating clinical trial sites, visit https://renovorx.com/clinical-trial/.

About RenovoGem

RenovoGem™ is the first drug-device combination product candidate to use the TAMP™ therapy platform through pressure-mediated delivery technology to deliver gemcitabine, an FDA-cleared chemotherapy, locally through the arterial wall to bathe tumor tissue in chemotherapy. RenovoGem is currently being evaluated in the phase III randomized, open-label clinical trial study TIGeR-PaC in patients with locally advanced pancreatic cancer (LAPC). The company plans to investigate RenovoGem in extrahepatic cholangiocarcinoma (eCCA) in a clinical trial, anticipated to begin in the first half of 2023. RenovoGem is currently under investigation for intra-arterial delivery of gemcitabine and has not been approved for commercial sale. . .

About RenovoRx, Inc.

RenovoRx is a clinical-stage biopharmaceutical company developing targeted combination therapies for high unmet medical need. The company’s proprietary Transarterial Microperfusion Therapy Platform (TAMP™) is designed to bypass traditional systemic delivery methods and ensure precise therapeutic delivery to a target tissue, while minimizing systemic toxicities of a therapy. RenovoRx’s unique approach to drug delivery offers the potential for increased treatment safety, tolerability, and wider therapeutic windows. The company’s lead product candidate, RenovoGem™, combines gemcitabine with the company’s proprietary delivery system and is regulated by the FDA under its 505(b)2 pathway. RenovoGem is currently in a Phase III clinical trial (TIGeR-PaC) for the treatment of LAPC. RenovoRx is committed to transforming patients’ lives by offering innovative solutions to change the current paradigm of cancer care. For more information, visit www.renovorx.com. Follow RenovoRx on Facebook, LinkedIn and Twitter.

* According to a recent report from the American Cancer Society.

forward-looking statements

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, without limitation, statements about our clinical trials and studies, including anticipated timing, statements regarding the potential of RenovoTAMP®, RenovoCath® or RenovoGem™ or regarding our ongoing TIGeR-PaC Phase III clinical trial study at LAPC, statements regarding the potential of our candidate products to treat or provide clinically significant results for certain medical conditions or diseases, and our preliminary financial results, cash position, and related ability to continue as a going concern. Statements that are not purely historical are forward-looking statements. The forward-looking statements contained in this document are based on our current expectations and beliefs regarding future events, many of which, by their nature, are inherently uncertain, are beyond our control, and involve assumptions that may never materialize or may result be incorrect. These may include estimates, projections and statements related to our research and development plans, clinical trials, therapy platform, business plans, targets and expected operating results, which are based on current expectations and assumptions that are subject to known risks and uncertainties and unknowns that may cause actual results to differ materially from those expressed or implied in these forward-looking statements. These statements can 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 with respect to 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, which could cause actual events to differ materially from those projected or indicated by such statements, including, but not limited to: timing, progress, and results. potentials. from our preclinical studies, clinical trials and our research programs; interim results may not predict the outcome of our clinical trial, which may not demonstrate sufficient safety and efficacy to support regulatory approval of our candidate product, or the regulatory authority may disagree with our interpretation of the data; clinical research and development plans and schedules, and the regulatory process for our product candidates; Potential future regulatory milestones for our candidate products, including those related to current and planned clinical studies; our ability to use and expand our therapy platform to build a pipeline of product candidates; our ability to advance product candidates and successfully complete them in clinical trials; the timing or likelihood of regulatory filings and approvals; our estimates of the number of patients with the diseases we target and the number of patients who may enroll in our clinical trials; the commercialization potential of our candidate products, if approved; our ability and potential to successfully manufacture and supply our candidate products for clinical trials and for commercial use, if approved; future strategic arrangements and/or collaborations and the potential benefits of such arrangements; our estimates about expenses, future income, capital requirements and additional financing needs and our ability to raise additional capital; the adequacy of our existing cash and cash equivalents to fund our future operating expenses and capital expenditure requirements; our ability to retain the continuing service of our key personnel and to identify, hire and retain additional qualified personnel; the implementation of our strategic plans for our commercial and product candidates; the extent of protection we may 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 appropriately; the price, coverage and reimbursement of our candidate products, if approved; developments related to our competitors and our industry, including competing product candidates and therapies; negative impacts of the current COVID-19 pandemic on our operations; and other risks. Information about the above and additional risks can be found in the section titled “Risk Factors” in the documents 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 publicly update such forward-looking statements to reflect subsequent events or circumstances, except as required by law.



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