This study will be the Second Clinical Trial
Evaluating RenovoGem™, a Combination Drug-Device Product, in a
Difficult-to-Access Solid Tumor Cancer
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 the expansion of their clinical development pipeline in
preparation for the commencement of a second Phase III trial. The
CouGar Trial will evaluate RenovoGem in bile duct cancer,
specifically unresectable locally advanced extrahepatic
cholangiocarcinoma (eCCA).
“We are pleased to engage our first clinical site for our second
pivotal clinical trial. The CouGar Trial marks an important
milestone for RenovoRx as we expand our clinical pipeline for
RenovoGem into bile duct cancer, a difficult-to-treat solid tumor
cancer,” said Leesa Gentry, Senior Vice President of Clinical
Operations at RenovoRx. “I’m extremely proud of our team and our
collaborators for their tremendous work reinforcing our mission to
improve patient lives by delivering innovative therapies that can
potentially change the current paradigm of cancer care.”
The pivotal Phase III CouGar study is a randomized study
designed to evaluate the safety and efficacy of unresectable,
locally advanced eCCA using intravenous cisplatin, gemcitabine, and
durvalumab (all forms of chemotherapy) versus Trans-Arterial
Micro-Perfusion via RenovoGem (delivery system and gemcitabine)
with intravenous durvalumab. Oklahoma University (OU) Health is the
first clinical site for the CouGar study.
“Unfortunately, bile duct cancer today has a poor prognosis for
patients. Despite early diagnosis, the five-year survival rate is
approximately 24%,” said Paula Novelli, MD FSIR, CouGar National
Principal Investigator, and Associate Professor of Radiology and
Director of Interventional Radiology Research at the University of
Pittsburgh Medical Center. “There are currently limited treatment
options for patients diagnosed with this aggressive cancer, which
only prolongs life by a few months. The CouGar study brings hope
for a new treatment option. RenovoGem has the potential to meet the
urgent clinical need for a safe and effective therapy in this
important patient population.”
Dr. David Geller, Director, UPMC Liver Cancer Center, Richard L.
Simmons Professor of Surgery, University of Pittsburgh School of
Medicine is the CouGar study’s Co-Investigator.
“The current standard of care for bile duct cancer is systemic
(intravenous) chemotherapy, which has poor uptake and delivery
since there are few blood vessels feeding this type of tumor,” said
Dr. Hassan Hatoum, Principal Investigator, Associate Professor and
Hematologist and Oncologist at Oklahoma University Health
Stephenson Cancer Center – Gastrointestinal Cancer Clinic.
“RenovoRx’s clinical trial is evaluating targeted, trans-arterial
delivery of chemotherapy that is locally directed to the tumor
site. Our team looks forward to participating in the CouGar study
to bring this novel therapy to patients.”
RenovoGem received FDA Orphan Drug Designation for pancreatic
cancer and bile duct cancer which provides 7 years of market
exclusivity upon NDA approval.
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 (TAMPTM) 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, RenovoGemTM, 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®, RenovoGemTM or TAMPTM 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; our ability to comply with the
continued listing standards of Nasdaq Stock Market LLC (“Nasdaq”)
or the continued listing of our securities on Nasdaq; 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/20231221037143/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
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