Dr. Michael Pishvaian, Principal Investigator of Phase III TIGeR-PaC Clinical Trial, will Discuss Recent Interim Analysis and its Potential Practice-Changing Impact in Oncology
LOS ALTOS, Calif.–(BUSINESS WIRE)–RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing targeted combination therapies, today announced that ROTH Capital will host a Key Opinion Leader (KOL) webcast with Dr. Michael Pishvaian, Principal Investigator of the Phase III TIGeR-PaC clinical trial and Director of the Gastrointestinal, Developmental Therapeutics, and Clinical Research Programs at Johns Hopkins University. The webcast is scheduled for Thursday, June 15, 2023 at 10 a.m. ET. Register here.
The webcast will be moderated by Roth Capital, and discuss the recent interim analysis of the pivotal TIGeR-PaC study and its potential practice-changing impact in the oncology community. The study is investigating RenovoRx’s lead product candidate, RenovoGem™, to treat locally advanced pancreatic cancer (LAPC) through RenovoRx’s proprietary trans-arterial micro-perfusion (TAMP™) drug-delivery platform of FDA-approved gemcitabine.
Webcast Details:
Date: Thursday June 15, 2023
Time: 10:00 a.m. – 10:30 a.m. ET
Registration/Webcast Link: Register Here
The webcast will be available on the Events page in the Investors section of the Company’s website.
Additionally, Dr. Pishvaian will be presenting new secondary endpoint data from the TIGeR-PaC study interim analysis in a late-breaking oral presentation at the upcoming ESMO World Congress on Gastrointestinal Cancer (ESMO GI). The Phase III study has a primary endpoint of overall survival and several secondary endpoints, including progression-free survival (PFS). The study is designed to randomize 114 patients. Final analysis will be conducted after 86 events (deaths) from the stereotactic body radiation therapy (SBRT) population. The study includes two planned interim analyses, the first upon 30% (26 of 86) of total events and the second upon 60% (52 of 86) of total events.
ESMO GI will be held June 28 – July 1, 2023, in Barcelona, Spain, with the presentation scheduled for Thursday, June 29, 2023, at 8:50 AM CEST.
About Dr. Michael Pishvaian
Dr. Michael Pishvaian is Associate Professor in the Department of Oncology, and Director of the Gastrointestinal, Developmental Therapeutics, and Clinical Research Programs at the NCR Kimmel Cancer Center at Sibley Memorial Hospital at Johns Hopkins University School of Medicine.
Prior, Dr. Pishvaian was Associate Professor, in the Department of Gastrointestinal Oncology, and Co-director for Clinical Research at the Sheikh Ahmed Bin Zayed Al Nahyan Center for Pancreatic Cancer Research at the University of Texas, MD Anderson Cancer Center.
Dr. Pishvaian holds an MD and a PhD in Tumor Biology from Georgetown University. He remained at Georgetown after graduation, completing his medical residency in 2004, and completing a fellowship in Hematology and Oncology shortly after in 2007. He later served on the faculty at Georgetown until moving to MD Anderson in 2019.
Dr. Pishvaian is a translational oncologist, focused on providing novel therapy for patients, particularly in the areas of pancreatic cancer and refractory colorectal cancer. His work has been focused in the area of precision medicine, with a special focus on therapy targeted towards homologous recombination DNA repair deficient tumors, and Dr. Pishvaian is a Co-investigator on an NIH RO1 to study mechanisms of resistance to PARP inhibitor-based therapy.
About the TIGeR-PaC Study
TIGeR-PaC is a randomized multi-center Phase III open label clinical trial designed to investigate the Company’s first product candidate, RenovoGem™, which utilizes RenovoRx’s proprietary therapy platform, TAMP™, to provide targeted intra-arterial delivery of FDA-approved chemotherapy, gemcitabine, to treat locally advanced pancreatic cancer (LAPC) following stereotactic body radiation therapy (SBRT). The study is comparing treatment with TAMP versus standard of care 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 upfront induction chemotherapy and SBRT. Final analysis will be conducted after 86 protocol-specified events have occurred in the SBRT population with two planned interim analyses: the first analysis when 30% of the specified events has been reported and the second analysis when 60% of the events have been reported (expected in mid-2024).
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 RenovoGem
RenovoGem™ is the first drug-device combination product candidate that utilizes the TAMP™ therapy platform via pressure-mediated delivery technology to deliver gemcitabine, an FDA-approved chemotherapy, locally across the arterial wall to bathe tumor tissue in the chemotherapy. RenovoGem is currently being evaluated in the open label, randomized Phase III TIGeR-PaC clinical trial study in Locally Advanced Pancreatic Cancer (LAPC) patients. The Company plans to investigate RenovoGem in extrahepatic Cholangiocarcinoma (eCCA) in a clinical trial, which is anticipated to begin in the first half of 2023.
About RenovoRx, Inc.
RenovoRx is a clinical-stage biopharmaceutical company developing targeted combination therapies for high unmet medical needs. The Company’s proprietary Trans-Arterial Micro-Perfusion (TAMP™) therapy platform is designed to bypass traditional systemic delivery methods and ensure precise therapeutic delivery to a target tissue, while minimizing a therapy’s systemic toxicities. RenovoRx’s unique approach to drug-delivery offers the potential for increased treatment safety, tolerance, and wider therapeutic windows. The Company’s lead product candidate, RenovoGem™, combines gemcitabine with the company’s patented delivery system and is regulated by 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 the lives of patients by delivering innovative solutions to change the current paradigm of cancer care. For more information, visit www.renovorx.com. Follow RenovoRx on Facebook, LinkedIn and Twitter.
Contacts
Investor Contact:
KCSA Strategic Communications
Valter Pinto or Jack Perkins
T:212-896-1254
renovorx@kcsa.com
Media Contact:
Kimberly Ha
T: 917-291-5744
kimberly.ha@kkhadvisors.com