Researchers presenting four abstracts on different substudies, including the preliminary PK substudy, at the ASCO GI Cancers Symposium in San Francisco on January 19-21, 2023.
RenovoRx, Inc. (NASDAQ:RNXT), a biopharmaceutical company focused on the localized treatment of solid tumors, today announced initial results from a pharmacokinetic (PK) substudy within the phase III un-blinded randomized control TIGeR-PaC clinical trial to be presented at the 2023 ASCO Gastrointestinal (ASCO GI) Cancers Symposium this week. The TIGeR-PaC clinical trial is evaluating intra-arterial (IA) administration of gemcitabine (chemotherapy) using the proprietary RenovoRx Trans-Arterial Micro-Perfusion (RenovoTAMP) platform for targeted treatment of Locally Advanced Pancreatic Cancer (LAPC). The substudy provides clinical support that RenovoTAMP may increase local drug delivery and thus concentration at the tumor site while decreasing the debilitating side effects often associated with systemic intravenous (IV) delivery, which is the current standard of care.
Three additional abstracts supporting the use of RenovoTAMP with gemcitabine for treatment of LAPC will also be presented at the ASCO GI on January 19-21, 2023 in San Francisco, California, and available online.
“Intra-arterial Gemcitabine vs IV Gemcitabine PK Substudy in Patients with Locally Advanced Pancreatic Cancer,” presented by Amer H. Zureikat, MD, et al., evaluates RenovoTAMP for IA delivery of gemcitabine (chemotherapy) directly into tumors for higher local drug concentration and decreased systemic drug concentration and associated side effects. The PK substudy evaluates a sample of LAPC patients (N=13) participating in the TIGeR-PaC study and demonstrates that the cohort had an average greater than 50% reduction in systemic drug exposure with IA delivery of gemcitabine using RenovoTAMP when compared with IV administration. The substudy concludes that RenovoTAMP may increase local gemcitabine concentration, which may be beneficial in decreasing gemcitabine-related systemic side effects. Five TIGeR-PaC clinical sites participated in this substudy.
“The upcoming presentation of our TIGeR-PaC clinical trial substudy at ASCO GI highlights significant potential benefits for patients with LAPC,” said Ramtin Agah, MD, Chief Medical Officer and Founder of RenovoRx. “Targeted local delivery of standard dose gemcitabine via the RenovoTAMP therapy platform may be associated with significantly less systemic drug exposure. The clinical implications may be decreased side effects and enhanced chemotherapy delivery. Ongoing studies are quantifying the resulting impact on improving patients’ quality of life and extending lifespan.”
“This substudy data, and the additional three studies to be presented at ASCO GI, enhance the strong clinical momentum of our therapy platform as we prepare for our most significant milestone to date: the initial interim analysis for our randomized phase III TIGeR-PaC trial.” said Shaun Bagai, CEO of RenovoRx.
Three additional clinical data abstracts presented by researchers at ASCO GI with data from the induction phase of the TIGeR-PaC study help to advance the science behind pancreatic cancer. In one abstract, Dr. Amer H. Zureikat, et al. investigates Mesenteric Venous Thrombosis (MVT), often identified on routine imaging studies performed with LAPC, and concludes that severe MVT is more prevalent in this patient population than previously reported. Anticoagulation is also underutilized in this cohort; however, chemotherapy may have a beneficial effect in downstaging MVT beyond anticoagulation. In a second abstract, Dr. Karyn A. Goodman, et al. performs an exploratory analysis to compare the toxicity and efficacy between patients receiving either stereotactic body radiation therapy (SBRT) or intensity-modulated radiation therapy (IMRT) during the induction phase (prior to randomization) of the TIGeR-PaC study. When compared to IMRT, SBRT demonstrates improved tolerability for treatment of patients with LAPC with comparable clinical efficacy. It was this finding that led to the modification of the TIGeR-PaC study design in 2021. Finally, a third abstract presented by Michael J. Pishvaian, et al. focuses on the TIGeR-PaC trial design and status.
The poster presentations for the four RenovoRx abstracts to be presented at the ASCO GI Symposium will be available on RenovoRx’s website once available: https://renovorx.com/for-clinicians/.
About RenovoGem
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.
About the Phase III TIGeR-PaC Clinical Trial
TIGeR-PaC is an un-blinded randomized multi-center Phase III study evaluating the use of RenovoRx’s innovative therapy platform, RenovoTAMP® (RenovoRx Trans-Arterial Micro-Perfusion), with gemcitabine as a potential treatment option for LAPC. The study is evaluating the Company’s first product candidate, RenovoGem™, to treat locally advanced pancreatic cancer (LAPC) following stereotactic body radiation therapy (SBRT) 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. The study is designed to randomize 114 patients with all patients receiving up front SBRT and induction chemotherapy and 57 patients in each arm. Final analysis will be conducted after 86 deaths from the SBRT population. Additionally, the study includes two planned interim analyses, the first upon 30% (26 of 86) of the total and the second upon 60% (52 of 86) of the total.
To date, 47 out of 114 target post-SBRT/chemotherapy patients have been randomized in the TIGeR-PaC trial and the Company has received reports of 25 events (deaths) in this population.
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/.
