Study is Investigating RenovoGem™ as Potential
New Option for Pancreatic Cancer Treatment
Recent Positive Interim Data Analysis from
Study Revealed 60% Survival Benefit and 65% Side Effect Reduction
Versus 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 utilizes
RenovoRx’s proprietary therapy platform, TAMP™, to provide improved
and targeted intra-arterial delivery of FDA-approved gemcitabine
chemotherapy to treat Locally Advanced Pancreatic Cancer
(LAPC).
The study is comparing RenovoGem with standard of care treatment
(intravenous gemcitabine and nab-paclitaxel). RenovoRx recently
announced interim analysis data that suggested a 6-month
improvement in median overall survival and a 65% reduction in side
effects versus standard of care.
“Pancreatic cancer is expected to be the second largest cause of
cancer-related deaths before 2030*,” said Principal Investigator,
Salwan Al Mutar, MD, MSc, Assistant Professor at UT Southwestern
Medical Center. “Systemic, intra-venous chemotherapy uses blood
vessels to deliver treatment. However, pancreatic cancer tumors
have 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, M.D., RenovoRx’s Founder and Chief Medical Officer,
commented, “UT Southwestern Medical Center is one of the world’s
premier academic medical organizations, integrating research with
exceptional clinical care. We are excited Dr. Al Mutar and his team
are enrolling patients in this important and transformative study.
Our shared vision is providing cancer patients with novel therapies
to enhance survival and quality of life."
UT Southwestern is the most recent clinical trial site to join
the Phase III TIGeR-PaC study which continues enrolling patients at
U.S. sites. UT Southwestern’s staff of more than 2,800 providers is
responsible for groundbreaking medical advances and is committed to
translating science-driven research quickly to new clinical
treatments. Physicians there provide medical 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 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. RenovoGem is
currently under investigation for the 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
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.
* 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 but
not limited to statements regarding 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 in LAPC,
statements regarding the potential for our product candidates to
treat or provide clinically meaningful outcomes 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 herein are
based upon our current expectations and beliefs regarding future
events, many of which, by their nature, are inherently uncertain,
outside of our control and involve assumptions that may never
materialize or may prove to be incorrect. These may include
estimates, projections and statements relating to our research and
development plans, clinical trials, therapy platform, business
plans, objectives and expected operating results, which are based
on current expectations and assumptions that are subject to known
and unknown risks and uncertainties that may cause actual results
to differ materially from those expressed or implied by these
forward-looking statements. These statements may 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 regarding 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, that could cause
actual events to differ materially from those projected or
indicated by such statements, including, among other things: the
timing of the initiation, progress and potential results of our
preclinical studies, clinical trials and our research programs; the
interim results may not be predictive of the outcome of our
clinical trial, which may not demonstrate sufficient safety and
efficacy to support regulatory approval of our product candidate,
or the regulatory authority may disagree with our interpretation of
the data; research and clinical development plans and timelines,
and the regulatory process for our product candidates; future
potential regulatory milestones for our product candidates,
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 into, and successfully complete, clinical trials; the
timing or likelihood of regulatory filings and approvals; our
estimates of the number of patients who suffer from the diseases we
are targeting and the number of patients that may enroll in our
clinical trials; the commercialization potential of our product
candidates, if approved; our ability and the potential to
successfully manufacture and supply our product candidates for
clinical trials and for commercial use, if approved; future
strategic arrangements and/or collaborations and the potential
benefits of such arrangements; our estimates regarding expenses,
future revenue, capital requirements and needs for additional
financing and our ability to obtain additional capital; the
sufficiency of our existing cash and cash equivalents to fund our
future operating expenses and capital expenditure requirements; our
ability to retain the continued service of our key personnel and to
identify, hire and retain additional qualified personnel; the
implementation of our strategic plans for our business and product
candidates; the scope of protection we are able to 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 adequately; the pricing, coverage and
reimbursement of our product candidates, if approved; developments
relating to our competitors and our industry, including competing
product candidates and therapies; negative impacts of the ongoing
COVID-19 pandemic on our operations; and other risks. Information
regarding the foregoing and additional risks may be found in the
section entitled “Risk Factors” in documents that 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
update publicly such forward-looking statements to reflect
subsequent events or circumstances, except as required by law.
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Investor Contact: KCSA Strategic Communications Valter
Pinto or Jack Perkins T: 212-896-1254 renovorx@kcsa.com
Media Contact: Kimberly Ha T: 9172915744
kimberly.ha@kkhadvisors.com
Kevin Knight T: 214-732-9392 kknightpr@gmail.com
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