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, today announced
that Ripal Gandhi, M.D., FSIR, FSVM will present at the Symposium
on Clinical Interventional Oncology (“CIO”) which is being held
September 20-22, 2024, at the Loews Hotel in Miami Beach, Florida.
Dr. Gandhi’s presentation will highlight RenovoRx’s
TAMP (Trans-Arterial Micro-Perfusion) therapy
platform for the treatment of locally advanced pancreatic cancer
(“LAPC”) and recent publications of clinical data.
Dr. Gandhi, professor of Interventional
Radiology at the Miami Cancer Institute and Miami Cardiac and
Vascular Institute, Florida International University Herbert
Wertheim College of Medicine, is a Course Director for the
Symposium on CIO. Since 2018, Dr. Gandhi has been instrumental as a
principal investigator for the Miami Cancer Institute in RenovoRx’s
pivotal ongoing Phase III TIGeR-PaC clinical trial in LAPC.
Dr. Gandhi’s presentation will provide an
overview of the clinical challenges of the standard of care
treatment available to LAPC patients. Systemic (intravenous)
chemotherapy, while considered the standard-of-care for LAPC, is
often associated with debilitating side effects, and may have
limited effectiveness in treating this type of cancer due to tumors
lacking dedicated blood vessels critical for delivering
chemotherapy. Dr. Gandhi will highlight the TAMP therapy platform
and the opportunity it may give to LAPC patients as a potential
targeted oncology option for treatment.
Dr. Gandhi will also discuss the status of the
Company’s ongoing Phase III TIGeR-PaC study, which is evaluating
the use of the TAMP therapy platform with gemcitabine HCl in
patients with LAPC. Additionally, he will review a recent
publication in the international peer-reviewed journal, The
Oncologist®, of early-stage clinical data on the intra-arterial
administration of gemcitabine HCl utilizing the TAMP including
Phase I/II dose escalation safety study (RR1) and acquired data
from a post-marketing post-treatment observational registry study
(RR2).
Presentation
Details:Date: Saturday, September 21,
2024Title: New Frontiers in Pancreatic Cancer:
Transarterial and Transvenous ApproachesTime:
9:30am ETLocation: Loews Hotel in Miami Beach,
FloridaSpeaker: Ripal Gandhi, M.D., FSIR,
FSVMEvent Website: Home | Symposium on Clinical
Interventional Oncology (hmpglobalevents.com)
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 LAPC. RenovoRx’s first product
candidate using the TAMP technology is a novel investigational
oncology drug-delivery combination utilizing the Company’s
FDA-cleared RenovoCath® device
for the intra-arterial administration of chemotherapy, gemcitabine
HCl.
The first interim analysis in the Phase III
clinical trial was completed in March 2023, with the Independent
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 or early 2025.
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 across the arterial wall near the
tumor site to bathe the target 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. Its Phase III lead product candidate is a novel oncology
drug-device combination product. It is being investigated under a
U.S. investigational new drug application that is regulated by the
FDA’s 21 CFR 312 pathway. The investigational drug-device
combination candidate 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. The intra-arterial
infusion of gemcitabine HCl by the RenovoCath catheter is currently
being evaluated for the treatment of LAPC by the Center for Drug
Evaluation and Research (the drug division of FDA).
RenovoRx is also actively exploring other
commercialization strategies utilizing its TAMP technology and
FDA-cleared RenovoCath delivery system as a stand-alone device.
RenovoRx is committed to transforming the lives
of patients by delivering innovative solutions to change the
current paradigm of cancer care. The intra-arterial infusion of
gemcitabine HCl by the RenovoCath catheter is currently under
investigation and has not been approved for commercial sale.
For more information,
visit www.renovorx.com. Follow RenovoRx
on Facebook, LinkedIn, and X.
Cautionary Note Regarding
Forward-Looking StatementsThis press release and
statements made in connection therewith and at the Symposium on CIO
described herein contain forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, as amended,
including but not limited to statements regarding (i) our clinical
trials and studies, including anticipated timing, statements
regarding the potential of RenovoCath® 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 explore commercialization strategies utilizing
our TAMP technology. 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 that our
exploration of commercial opportunities for our TAMP technology may
not lead to viable, revenue generating operations; (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; (vi)
research and clinical development plans and timelines, and the
regulatory process for our product candidates; (vii) future
potential regulatory milestones for our product candidates,
including those related to current and planned clinical studies;
(viii) our ability to use and expand our therapy platform to build
a pipeline of product candidates; (ix) our ability to advance
product candidates into, and successfully complete, clinical
trials; (x) the timing or likelihood of regulatory filings and
approvals; (xi) 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; (xii) the commercialization
potential of our product candidates, if approved; (xiii) our
ability and the potential to successfully manufacture and supply
our product candidates for clinical trials and for commercial use,
if approved; (xiv) future strategic arrangements and/or
collaborations and the potential benefits of such arrangements;
(xv) our estimates regarding expenses, future revenue, capital
requirements and needs for additional financing and our ability to
obtain additional capital; (xvi) the sufficiency of our existing
cash and cash equivalents to fund our future operating expenses and
capital expenditure requirements; (xvii) our ability to retain the
continued service of our key personnel and to identify, and hire
and retain additional qualified personnel; (xviii) the
implementation of our strategic plans for our business and product
candidates; (xix) the scope of protection we are able to establish
and maintain for intellectual property rights, including our
therapy platform, product candidates and research programs; (xx)
our ability to contract with third-party suppliers and
manufacturers and their ability to perform adequately; (xxi) the
pricing, coverage and reimbursement of our product candidates, if
approved; and (xxii) 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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