Data shows that the Trans-Arterial
Micro-Perfusion (TAMP) platform increases intra-arterial pressure,
improving drug delivery with 100-fold increase local tissue
concentration of the therapy
TAMP offers the potential to increase efficacy,
improve safety and widen therapeutic window of drugs or other
agents
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 a publication of pre-clinical studies
supporting the efficacy and drug delivery mechanism of RenovoRx’s
Trans-Arterial Micro-Perfusion (“TAMP”) therapy platform.
The data was published online in the peer-reviewed Journal of
Vascular Interventional Radiology(“JVIR”) journal and will also
be published in the print version.
The manuscript is authored by Khashayar Farsad, MD, PhD of the
Department of Interventional Radiology at Oregon Health and Science
University, and co-authored by Paula M. Novelli, MD, of the
University of Pittsburgh Hillman Cancer Center, together with other
researchers, including RenovoRx’s Chief Medical Officer, Dr. Ramtin
Agah. Access the JVIR abstract:
https://pubmed.ncbi.nlm.nih.gov/38508449/.
Currently, most cancer patients with solid tumors receive
chemotherapy intravenously, meaning it is introduced systemically
into the entire body and causes well known adverse side effects.
RenovoRx’s patented TAMP therapy platform is designed to bypass
traditional systemic delivery methods and provide precise delivery
to bathe the target solid tumor in chemotherapy. This precise
delivery also creates the potential to minimize a therapy’s
systemic toxicities.
The pre-clinical data published in JVIR showed a 100-fold (two
orders of magnitude) increase in local tissue concentration of the
therapy with TAMP compared to conventional intravenous (IV)
delivery. TAMP also showed advantages compared to historically
available intra-arterial (IA) delivery approaches. TAMP’s novel
approach to treatment offers the potential to increase an oncology
therapy’s efficacy, improve safety, and widen its therapeutic
window by focusing its distribution uniformly in target tissue.
“TAMP has the potential to provide a valuable treatment option
to patients who have been diagnosed with solid tumors that may be
difficult-to-treat,” said Dr. Farsad. “The study shows a possible
mechanism for how TAMP can increase local therapeutic tissue
concentration in solid tumors that is independent from traditional
catheter-directed therapy. We are awaiting final outcomes of the
Phase III clinical trial, currently underway, to validate this
benefit.”
Dr. Farsad adds, “This platform has the potential to extend
across a variety of unmet needs for localized therapeutic drug
delivery.”
About the Phase III TIGeR-PaC Clinical Trial
TIGeR-PaC is RenovoRx’s ongoing Phase III randomized
multi-center study evaluating the proprietary TAMP therapy platform
for the treatment of Locally Advanced Pancreatic Cancer (LAPC.)
RenovoRx’s first product candidate, RenovoGem™, is a novel
oncology drug-delivery combination utilizing TAMP administration
technology combined with the FDA-approved chemotherapy,
gemcitabine. The TIGeR-PaC study is comparing treatment with TAMP
to systemic intravenous chemotherapy, the current standard of
care.
The first interim analysis in the TIGeR-PaC study occurred at
the 26th event of the specified events (deaths), and was completed
in March 2023, with the Data Monitoring Committee recommending a
continuation of the study. The TIGeR-PaC study’s primary endpoint
is a 6-month Overall Survival (OS) benefit with secondary endpoints
including reduced side effects versus standard of care.
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 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
proprietary 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 by the Center for
Drug Evaluation and Research (the drug division of FDA.)
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 Statements
This 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 that the pre-clinical data described herein may not
provide any future benefits to 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240521237712/en/
KCSA Strategic Communications Valter Pinto or Jack Perkins
T:212-896-1254 renovorx@kcsa.com
RenovoRx (NASDAQ:RNXT)
過去 株価チャート
から 11 2024 まで 12 2024
RenovoRx (NASDAQ:RNXT)
過去 株価チャート
から 12 2023 まで 12 2024
