RenovoRx Announces ROTH Capital Key Opinion Leader (KOL) Webcast on June 15
12 Junho 2023 - 9:30AM
Business Wire
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
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20230612005164/en/
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
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