On May 25, 2023 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing targeted combination therapies, reported the acceptance of a late-breaking oral presentation for its lead product candidate RenovoGem, in the treatment of locally advanced pancreatic cancer (LAPC), at the upcoming ESMO (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer (ESMO GI) (Press release, Renovorx, MAY 25, 2023, View Source [SID1234632123]). The conference 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.

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The presentation will feature new secondary endpoint data from the first interim analysis triggered in the Phase III TIGeR-PaC study – a multi-center, open-label clinical trial. The study is evaluating RenovoGem to treat LAPC through RenovoRx’s proprietary trans-arterial micro-perfusion (TAMP) drug-delivery platform of FDA-approved gemcitabine.

The Phase III study has a primary endpoint of overall survival and several secondary endpoints, including progression-free survival (PFS) and quality of life. 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.

Data from the planned first interim analysis of the Phase III TIGeR-PaC study, presented at recent American Association of Clinical Research (AACR) (Free AACR Whitepaper) 2023, demonstrated a 6-month median overall survival difference between the test arm (RenovoGem) and control arm (standard of care gemcitabine and Abraxane) along with a 65% reduction in adverse events.

"We are thrilled to announce that Dr. Michael J. Pishvaian, Principal Investigator, will present new secondary endpoint data from the interim analysis in our pivotal study at the upcoming ESMO (Free ESMO Whitepaper) GI," said Shaun Bagai, CEO, RenovoRx. "This data will notably include PFS from the Phase III study, which has historically been used as a registrational endpoint in FDA New Drug Applications both in accelerated and traditional approvals. We look forward to continued engagement with leading oncologists in the field as we advance RenovoGem and our delivery platform’s potential to benefit cancer patients."

Presentation Details:

Abstract Title: "The Phase 3 study Targeted Intra-Arterial Gemcitabine vs. Continuation of IV Gemcitabine plus Nab-Paclitaxel following Induction with Sequential IV Gemcitabine plus Nab-Paclitaxel and Radiotherapy for Locally Advanced Pancreatic Cancer (TIGeR-PaC) trend toward a survival benefit at its first interim analysis"

Abstract Number: LBA-1

Presenting Author: Michael Jon Pishvaian, M.D., Ph.D., Director of Gastrointestinal, Developmental Therapeutics and Clinical Research Programs, Associate Professor of Oncology, John Hopkins School of Public Health

Presentation Date and Time: Thursday, June 29, 2023, at 8:50 – 9:00 AM CEST

Data presented at the conference will be available to view in the Clinicians section of the RenovoRx website following the ESMO (Free ESMO Whitepaper) GI Conference.

The treatment of LAPC remains a clinical challenge with a median survival of 15-18 months from diagnosis. RenovoGem delivers gemcitabine directly to the tumor site, enhancing the therapeutic effectiveness while potentially minimizing the systemic side effects commonly associated with traditional chemotherapy intravenous administration, and potentially improving patient outcomes. RenovoGem is currently under investigation for the intra-arterial delivery of gemcitabine and has not been approved for commercial sale.

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 View Source