RenovoRx, Inc. (“RenovoRx” or the
“Company”) (Nasdaq: RNXT), a clinical-stage
biopharmaceutical company developing novel precision oncology
therapies based on a local drug-delivery platform, announced today
that the first patient has been enrolled at the University of
Nebraska Medical Center (“UNMC”) in RenovoRx’s ongoing pivotal
Phase III TIGeR-PaC clinical trial for Locally Advanced Pancreatic
Cancer (LAPC).
The TIGeR-PaC study is using RenovoRx’s TAMP™
(Trans-Arterial Micro-Perfusion) therapy platform, to evaluate the
Company’s first product candidate, RenovoGem, which is a
drug-device combination that utilizes pressure-mediated delivery of
gemcitabine (chemotherapy) across the arterial wall near the tumor
site to bathe the target tumor. The study is comparing treatment
with TAMP in LAPC to the current standard-of-care (systemic
intravenous chemotherapy).
“Pancreatic cancer is aggressive, and difficult
to detect and treat,” said Associate Professor at UNMC, Kelsey
Klute, MD, Division of Oncology & Hematology Gastrointestinal
Cancer, Pancreatic Cancer. “Chemotherapy given intravenously is the
current standard treatment for most patients with pancreatic
cancer. One of the biggest challenges in treating pancreatic cancer
is that the tumor cells build a thick layer of scar tissue around
the tumor, and this scar tissue makes it difficult for drugs to
penetrate the tumor itself. I think this is one of the reasons that
many investigational drugs tested in pancreatic cancer fail – they
simply aren’t reaching the tumor at high enough concentration to
have an effect. The ongoing TIGeR-PaC study is evaluating
RenovoRx’s innovative targeted (intra-arterial) approach to
chemotherapy delivery, which aims to deliver medicine theoretically
through the layer of scar tissue directly to the tumor in the
pancreas. We are hopeful that this approach will lead to better
outcomes for our patients: both improved survival as well as
decreased side effects. With this initial enrollment since
launching our participation in the study at UNMC just a little over
a month ago, I am encouraged by the interest in this important
study at UNMC.”
“We are excited that UNMC has begun enrollment
with their first patient in our ongoing Phase III TIGeR-PaC
clinical trial,” said Leesa Gentry, Chief Clinical Officer of
RenovoRx. “UNMC is the most recent clinical site to join our
pivotal TIGeR-PaC clinical study. We believe UNMC will help drive
enrollment of the TIGeR-PaC trial to completion next year because
they treat a larger number of patients diagnosed with pancreatic
cancer. We are proud to collaborate with them as they strive to
provide best-in-class care and share our deep commitment to
improving outcomes for patients diagnosed with difficult-to-treat
tumors, like pancreatic cancer."
UNMC is the most recent clinical trial site to
join the Phase III TIGeR-PaC study. The mission of the College of
Medicine at the University of Nebraska Medical Center is to lead
the world in transforming lives to create a healthy future for all
individuals and communities through premier educational programs,
innovative research, and extraordinary patient care.
The TIGeR-PaC clinical trial 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://clinicaltrials.gov/
(NCT03257033).
About the TIGeR-PaC Clinical
Trial TIGeR-PaC is an ongoing Phase III randomized
multi-center study evaluating the proprietary
TAMP™ (Trans-Arterial Micro-Perfusion) therapy
platform for the treatment of Locally Advanced Pancreatic Cancer
(LAPC.) RenovoRx’s first product candidate using the TAMP
technology, RenovoGem™, is a novel investigational
oncology drug-delivery combination utilizing the Company’s
FDA-cleared RenovoCath® device
for the intra-arterial administration of chemotherapy,
gemcitabine.
The first interim analysis in the Phase III
clinical trial was completed in March 2023, with the Data
Monitoring Committee recommending a continuation of the study. The
TIGeR-PaC study is investigating TAMP in LAPC. The study's primary
endpoint is a 6-month Overall Survival benefit with secondary
endpoints including reduced side effects versus standard of care.
The second interim analysis for this study will be triggered by the
52nd event, which is estimated to occur in late 2024.
About Locally Advanced Pancreatic Cancer
(LAPC)According to the American Cancer Society’s Cancer
Facts & Figures 2024 and PanCAN, respectively, pancreatic
cancer has a 5-year all stages combined relative survival rate of
13% (Stages I-IV) and is on track to be the second leading cause of
cancer-related deaths before 2030. LAPC is diagnosed when the
disease has not spread far beyond the pancreas, however, has
advanced to the point where it cannot be surgically removed. LAPC
is typically associated with patients in Stage 3 of the disease as
determined by the TNM (tumor, nodes and metastasis) grading
system.
About RenovoRx, Inc.RenovoRx is
a clinical-stage biopharmaceutical company developing novel
precision oncology therapies based on a local drug delivery
platform for high unmet medical need with a goal to improve
therapeutic outcomes for cancer patients undergoing treatment.
RenovoRx’s patented Trans-Arterial Micro-Perfusion
(TAMP™) therapy platform is designed to ensure
precise therapeutic delivery to directly target the tumor while
potentially minimizing a therapy’s toxicities versus systemic
intravenous therapy. RenovoRx’s novel and patented approach to
targeted treatment offers the potential for increased safety,
tolerance, and improved efficacy. Our Phase III lead product
candidate, RenovoGem™, a novel oncology
drug-device combination product, is being investigated under a U.S.
investigational new drug application that is regulated by the FDA’s
21 CFR 312 pathway. RenovoGem is currently being evaluated for the
treatment of locally advanced pancreatic cancer (LAPC) by the
Center for Drug Evaluation and Research (the drug division of FDA).
RenovoGem utilizes RenovoCath®, the Company’s
FDA-cleared drug-delivery device, indicated for temporary vessel
occlusion in applications including arteriography, preoperative
occlusion, and chemotherapeutic drug infusion.
RenovoRx is also actively exploring the use of
TAMP to treat cancers beyond LAPC as well as other
commercialization strategies for its technology.
RenovoRx is committed to transforming the lives
of patients by delivering innovative solutions to change the
current paradigm of cancer care. RenovoGem is currently under
investigation for TAMP therapeutic delivery of gemcitabine and has
not been approved for commercial sale.
For more information,
visit www.renovorx.com. Follow RenovoRx
on Facebook, LinkedIn, and Twitter.
Cautionary Note Regarding
Forward-Looking StatementsThis press release and
statements of the Company’s management made in connection therewith
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 (i) our clinical trials and studies, including
anticipated timing, statements regarding the potential of
RenovoCath®, RenovoGem™ or TAMP™ or regarding our ongoing TIGeR-PaC
Phase III clinical trial study in LAPC, (ii) the potential for our
product candidates to treat or provide clinically meaningful
outcomes for certain medical conditions or diseases and (iii) our
efforts to expand our intellectual property. 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,
intellectual property development, clinical trials, our therapy
platform, business plans, financing 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
and adversely 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: (i)
the risk the publication of data as described herein will not lead
to any benefits for the Company; (ii) circumstances which would
adversely impact our ability to efficiently utilize our cash
resources on hand or raise additional funding, (iii) the timing of
the initiation, progress and potential results (including the
results of interim analyses) of our preclinical studies, clinical
trials and our research programs; (iv) the possibility that interim
results may not be predictive of the outcome of our clinical
trials, which may not demonstrate sufficient safety and efficacy to
support regulatory approval of our product candidate, (v) that the
applicable regulatory authorities may disagree with our
interpretation of the data; research and clinical development plans
and timelines, and the regulatory process for our product
candidates; (vi) future potential regulatory milestones for our
product candidates, including those related to current and planned
clinical studies; (vii) our ability to use and expand our therapy
platform to build a pipeline of product candidates; (viii) our
ability to advance product candidates into, and successfully
complete, clinical trials; (ix) the timing or likelihood of
regulatory filings and approvals; (x) 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; (xi) the
commercialization potential of our product candidates, if approved;
(xii) our ability and the potential to successfully manufacture and
supply our product candidates for clinical trials and for
commercial use, if approved; (xiii) future strategic arrangements
and/or collaborations and the potential benefits of such
arrangements; (xiv) our estimates regarding expenses, future
revenue, capital requirements and needs for additional financing
and our ability to obtain additional capital; (xv) the sufficiency
of our existing cash and cash equivalents to fund our future
operating expenses and capital expenditure requirements; (xvi) our
ability to retain the continued service of our key personnel and to
identify, and hire and retain additional qualified personnel;
(xvii) the implementation of our strategic plans for our business
and product candidates; (xviii) the scope of protection we are able
to establish and maintain for intellectual property rights,
including our therapy platform, product candidates and research
programs; (xix) our ability to contract with third-party suppliers
and manufacturers and their ability to perform adequately; (xx) the
pricing, coverage and reimbursement of our product candidates, if
approved; and (xxi) developments relating to our competitors and
our industry, including competing product candidates and therapies.
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.
Contact:KCSA Strategic
CommunicationsValter Pinto or Jack
PerkinsT:212-896-1254RenovoRX@KCSA.com
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