RenovoRx Holds a Strong Intellectual Property
(IP) Portfolio with 9 Issued Patents for its Proprietary
Trans-Arterial Micro-Perfusion (TAMP™) Therapy Platform and
Delivery System
New Patent Would Expand IP Coverage for TAMP to
Deliver Additional Therapeutic Classes Across DNA/RNA Altering
Modalities, Cell Therapy, and Antibody-Based Therapies
RenovoRx, Inc. (Nasdaq: RNXT), a clinical-stage
biopharmaceutical company developing novel precision oncology
therapies based on a local drug-delivery platform, announced today
that the Company has filed an international patent application
under the Patent Cooperation Treaty (PCT) for its novel
Trans-Arterial Micro-Perfusion (TAMP) therapy platform. The Company
already holds a strong intellectual property portfolio with 9
issued patents and 9 pending patents for its proprietary TAMP
platform and delivery system in the US, EU, and Asia. The patent
portfolio covers two main areas, mechanical and biological.
The new international patent application is filed under the
Patent Cooperation Treaty on methods and apparatuses that may be
used to deliver one or more therapeutic agents through the vaso
vasorum (small blood vessels that supply the walls of larger
arteries or veins) to a target tissue. RenovoRx believes that these
methods and apparatuses via the TAMP therapy platform may provide a
novel and important pathway for the targeted delivery of
therapeutic classes across DNA/RNA-altering modalities, cell
therapy, oncolytic viruses, bi-specific antibodies, and monoclonal
antibodies for the treatment of a variety of clinical indications.
The Company anticipates that the patent application will be
published in May of 2024.
"This patent application further expands the value of TAMP into
the delivery of larger therapeutic assets, as a unique platform in
oncology, beyond our current Phase III clinical asset," said Shaun
Bagai, CEO, RenovoRx. "Once approved, it will further extend our IP
coverage, opening up new market potential, expanding the upside
value proposition of TAMP commercially. We look forward to
providing further highlights and updates related to this patent, as
well as our progress in our Phase III TIGeR-PaC clinical
program."
TAMP is being investigated in the Company’s Phase III TIGeR-PaC
clinical trial, an ongoing randomized multi-center study. The study
is evaluating trans-arterial delivery of an FDA-approved
chemotherapy, gemcitabine, to treat Locally Advanced Pancreatic
Cancer (LAPC) following stereotactic body radiation therapy (SBRT).
The study is comparing treatment of gemcitabine with TAMP versus
systemic IV administration of gemcitabine and nab-paclitaxel.
The first of two interim analyses was completed in March 2023,
and the Data Monitoring Committee (DMC) recommended a continuation
of the study. The study is prespecified to provide a primary
endpoint of a 6-month Overall Survival benefit and secondary
endpoints including reduced side effects versus standard of
care.
About RenovoRx, Inc.
RenovoRx is a clinical-stage biopharmaceutical company
developing proprietary targeted combination therapies for high
unmet medical need with a goal to improve therapeutic outcomes for
cancer patients undergoing treatment. The Company’s proprietary
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 (IV) therapy). RenovoRx’s unique 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 US IND that is regulated by FDA 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.)
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.
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 RenovoCath®, RenovoGem™ or TAMP™ 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
possibility that 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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version on businesswire.com: https://www.businesswire.com/news/home/20231213583366/en/
Investor Contact: KCSA Strategic Communications Valter
Pinto or Jack Perkins T:212-896-1254 renovorx@kcsa.com
Media Contact: Kimberly Ha KKH Advisors 917-291-5744
kimberly.ha@kkhadvisors.com
RenovoRx (NASDAQ:RNXT)
過去 株価チャート
から 5 2024 まで 6 2024
RenovoRx (NASDAQ:RNXT)
過去 株価チャート
から 6 2023 まで 6 2024