Study to be Presented at the Global
Embolization Oncology Symposium Technologies (GEST) 2022
RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a
biopharmaceutical company and innovator in targeted cancer therapy,
today announces that it will present preclinical research
supporting its planned second clinical indication, bile duct
cancer, also known as cholangiocarcinoma, at the Global
Embolization Oncology Symposium Technologies (GEST) 2022, today in
New York City. The study demonstrates the potential utility of
RenovoRx’s proprietary Trans-Arterial Micro-Perfusion
(RenovoTAMPTM) therapy platform for the treatment of
cholangiocarcinoma.
Cholangiocarcinoma is a rare and aggressive cancer that forms in
the bile ducts -- thin tubes that carry a digestive fluid, called
bile, from the liver to other digestive organs. Most people with
cholangiocarcinoma do not have symptoms until the disease becomes
more advanced, making early diagnoses difficult. Like pancreatic
cancer, which the Company is evaluating in a Phase 3 study, bile
duct tumors that grow outside of the liver lack tumor feeder blood
vessels, which provide a pathway between the blood stream and the
tumor. Tumor feeders are critical to the effectiveness of systemic
chemotherapy. Published research supports that without direct
access to the tumor, systemic chemotherapy circulates through the
body, without a significant amount of chemotherapy reaching the
tumor.
RenovoRx plans to launch a Phase 2/3 study in cholangiocarcinoma
in the second half of 2022. The Company also received Orphan Drug
Designation for this clinical indication in April 2021.
“We are pleased to present our preclinical research data
studying RenovoTAMP’s utility in cholangiocarcinoma at this
peer-reviewed, scientific meeting – GEST 2022,” said Dr. Ramtin
Agah, Chief Medical Officer and Co-Founder at RenovoRx. “To be
effective, chemotherapy must be able to reach the tumor. RenovoTAMP
was designed to bring the chemotherapy to the tumor when there is
no other pathway available. Through localized delivery of
chemotherapy, we are hoping to provide a more effective treatment
option for cancer patients, reduce the debilitating side effects
typical of standard of care systemic chemotherapy and improve
patient survival for cancers like cholangiocarcinoma.”
The purpose of the preclinical study was to compare the
effectiveness of delivery of a chemotherapeutic agent inside the
bile duct via the gall bladder versus intra-arterially, into the
tissue surrounding the bile duct (RenovoTAMP). This study
determined that delivery via the gallbladder resulted in zero
tissue penetration. In comparison, intra-arterial delivery resulted
in extensive tissue penetration, confirming the Company’s plan to
utilize RenovoTAMP in its planned Phase 2 study.
The abstract and poster for the study, “Localized Delivery of
Chemotherapy Through the Bile Duct Using a Double Balloon Catheter
in A Porcine Model,” are available on RenovoRx’s website:
https://renovorx.com/for-clinicians/.
RenovoTAMP is currently being investigated in the Phase 3
TIGeR-PaC clinical trial as a potential treatment option for
patients with unresectable locally advanced pancreatic cancer.
RenovoRx received Orphan Drug Designation for pancreatic cancer in
2018.
About RenovoRx, Inc.
RenovoRx is a clinical-stage biopharmaceutical company focused
on fighting cancer through the localized treatment of difficult to
treat tumors via its proprietary RenovoRx Trans-Arterial
Micro-Perfusion (RenovoTAMPTM) therapy platform. RenovoTAMP
utilizes approved chemotherapeutics with validated mechanisms of
action and well-established safety and side effect profiles, with
the goal of increasing their efficacy, improving their safety, and
widening their therapeutic window. RenovoRx’s lead product
candidate, RenovoGemTM, is a combination of gemcitabine and our
patented delivery system, RenovoCath®, and is regulated by the FDA
as a novel oncology drug product to treat unresectable locally
advanced pancreatic cancer (LAPC). RenovoGem is currently being
studied in the Phase 3 TIGeR-PaC trial for the treatment of
LAPC.
RenovoRx’s patent portfolio includes seven U.S. patents for its
technology. RenovoRx has been granted Orphan Drug Designation for
intra-arterial delivery of gemcitabine for the treatment of both
pancreatic cancer and bile duct cancer.
RenovoRx won the Drug Delivery Technology category of the Fierce
Innovation Awards – Life Sciences Edition 2020 for its RenovoTAMP
technology.
Learn more by visiting the RenovoRx website or following us 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, statements regarding the potential of RenovoTAMPTM or
regarding our ongoing TIGeR-PaC Phase 3 clinical trial in locally
advanced pancreatic cancer, and planned Phase 2/3 clinical trial in
cholangiocarcinoma; and statements regarding the potential for our
product candidates to treat or provide clinically meaningful
outcomes for certain medical conditions or diseases. 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; 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 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/20220519005276/en/
Company Contact: RenovoRx, Inc. Shaun R. Bagai, CEO
Christopher J. Lehman, CFO
Investor Contact: KCSA Strategic Communications Valter
Pinto or Jack Perkins T: 212-896-1254 renovorx@kcsa.com
Media Contact: Knight Marketing Communications, Ltd.
Kevin Knight T: 206-451-4823 kknightpr@gmail.com
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