Six-Month Overall Survival Benefit with
RenovoGem Versus Systemic Chemotherapy, and 65% reduction in
adverse effects and clinically meaningful overall survival
trend
Results highlight RenovoGem’s potential to
change treatment paradigm for Locally Advanced Pancreatic
Cancer
RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a
clinical-stage biopharmaceutical company developing targeted
combination therapies, today presented new positive data on
progression-free survival (PFS) from the pivotal Phase III open
label TIGeR-PaC study of RenovoGem (intra-arterial administration
of gemcitabine) in locally advanced pancreatic cancer (LAPC). The
interim data was featured as a late-breaking oral presentation at
the 2023 ESMO World Congress on Gastrointestinal Cancer, and
presented by Michael J. Pishvaian, M.D., Ph.D., Johns Hopkins
Medicine and Principal Investigator (PI) of the TIGeR-PaC
study.
The interim analysis demonstrated an eight-month median PFS
benefit, 15 versus 7 months, in delaying the progression of cancer
for patients receiving treatment with RenovoGem versus
standard-of-care. PFS is the measure of the length of time from
study randomization to either death or progression of disease.
“Clinical practice has been waiting decades for a meaningful
advancement in the standard of care for pancreatic cancer
treatment, with less toxicity and better outcomes. The new data
from the TIGeR-PaC interim results support that RenovoGem has the
potential to more than double progression-free survival compared to
systemic chemotherapy alone in this difficult-to-treat cancer,
which demonstrates support for a new treatment standard,” said
Michael J. Pishvaian, M.D., Ph.D., PI of the TIGeR-PaC study. “This
data has the potential to be a paradigm-shifting treatment for
patients at risk of cancer progression, including those who have
limited well-tolerated options.”
The study is designed to randomize 114 patients (57 in each arm)
with all patients receiving upfront induction chemotherapy and
stereotactic body radiation therapy (SBRT). The TIGeR-PaC Data
Monitoring Committee met and determined the interim data is
promising and warrants continuation of this pivotal trial. As of
the date of the analysis, 45 patients from U.S. sites had been
randomized in this trial and the survival status of all subjects
was used for the analysis.
- 23 patients were randomized to intra-arterial (IA) gemcitabine
(RenovoGem investigational treatment) arm and 22 patients to
continuation of intravenous (IV) gemcitabine and nab-paclitaxel
(standard-of-care) control arm.
- The median PFS data in the IV gemcitabine and nab-paclitaxel
control arm was 7 versus 15 months in the IA RenovoGem arm.
- Patients had a greater than 65% reduction in adverse events
compared to the control arm.
- The median overall survival in the IV gemcitabine and
nab-paclitaxel control arm was 10 months, versus 16 months in the
IA RenovoGem arm, from time of randomization. (NOTE: Both arms’
median overall survival calculations do not include approximately
5.5 months of life from diagnosis to randomization during the
induction chemotherapy and radiation phase of the trial.)
The TAMP™ (Trans-arterial Micro-perfusion) therapy platform
delivers gemcitabine directly to the tumor site, potentially
enhancing the therapeutic effectiveness while potentially
minimizing the systemic side effects, commonly associated with
traditional chemotherapy (IV) administration, and improving patient
outcomes.
“The TIGeR-PaC study results reinforce the intended clinical
advantage that TAMP brings to pancreatic cancer treatment, versus
the non-targeted approach of the current standard of care (IV)
therapy,” said Ramtin Agah, M.D., Chief Medical Officer, RenovoRx.
“The first look at interim analysis data of our pivotal trial
supports this important advantage in overcoming the barrier of
solid tumors in resisting drug uptake.”
“Placing patients at the center of everything we do is a
critical focus. We are thrilled to announce these pivotal TIGeR-PaC
study results supporting RenovoGem’s meaningful clinical benefit
and impressive safety profile for patients with LAPC,” said Shaun
Bagai, CEO, RenovoRx. “We are committed to advancing this therapy
as rapidly as possible, with the goal of delivering a treatment
that is capable of improving survival outcomes while preserving
patient quality of life in pancreatic cancer.”
TIGeR-PaC is currently enrolling unresectable LAPC patients at
several sites across the U.S. To learn more about the study and the
participating clinical trial sites, visit
https://renovorx.com/clinical-trial/. RenovoGem is currently under
investigation for TAMP therapeutic delivery of gemcitabine and has
not been approved for commercial sale.
About Locally Advanced Pancreatic Cancer (LAPC)
According to American Cancer Society’s Cancer Facts &
Figures 2023, pancreatic cancer has a 5-year combined overall
survival rate of 12% (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 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 systemic chemotherapy, locally across the arterial
wall to bathe tumor tissue in the chemotherapy. RenovoGem is
currently being evaluated in the 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.
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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: 917-291-5744
kimberly.ha@kkhadvisors.com
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