Sub-study of the pivotal Phase III TIGeR-PaC
clinical trial offers important data to potentially assist in
optimization of TAMP therapy
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 highlights a presentation of a
clinical data abstract at the recent 2024 Society of Interventional
Radiology (SIR) Annual Scientific Meeting, held March 23-27, 2024
in Salt Lake City, Utah. Clinical data was presented by David
Sperling, MD, Associate Professor of Radiology at Columbia
University Irving Medical Center in New York.
Dr. Sperling, together with his co-authors, presented
“Mesenteric Venous Thrombosis as a Predictor of Target Artery
Thrombosis and Tran-Arterial Micro Perfusion Treatment Completion
Among Patients with Locally Advanced Pancreatic Cancer (LAPC),”
a sub-study of RenovoRx’s ongoing pivotal Phase III TIGeR-PaC
clinical trial. In this sub-study, baseline abdominal CT imaging
completed prior to randomization into the TIGeR-PaC study was
reviewed for the presence or absence of Mesenteric Venous
Thrombosis (MVT) by an independent core imaging radiologist.
Outcomes examined 1) patient inability to complete the planned 8
treatments with RenovoRx’s patented Trans-Arterial
Micro-Perfusion (TAMP™) therapy platform, 2) target vessel
thrombosis during or after TAMP, and 3) side effects of pain or
discomfort associated with the use of TAMP.
Patients with pancreatic cancer are commonly at risk of both
arterial and venous thromboembolism, obstructions of an artery or
blood vessel by a blood clot, and MVT can also be an incidental
finding when treating this important patient population. MVT is a
blood clot impacting one or more of the major veins that drain
blood from the intestine that may make certain treatments
difficult.
The data presentation highlighted that of the 25 patients
randomized to the TAMP therapy, 6 failed to complete all 8 planned
procedures due to thrombosis of the targeted arterial artery. Among
those 6 patients, the prevalence of MVT on the baseline abdominal
CT imaging was 100%.
“Our sub-study presents important data to assist in optimization
of TAMP with better risk stratification of patients while improving
guidance of TAMP therapy for LAPC treatment,” said Dr. Sperling.
“After retrospectively evaluating 25 patients randomized to the
TAMP therapy in the TIGeR-PaC study, we concluded that MVT on
baseline CT imaging is a strong predictor of target artery
thrombosis which could be a limitation of TAMP for repeated
procedures for these specific patients.”
“Identification of the presence of MVT as a risk factor, if
addressed clinically, can potentially increase frequency of
patients undergoing successful TAMP procedures during treatment
with proper management,” said Ramtin Agah, MD, Chief Medical
Officer and Founder of RenovoRx. “It is important to understand
appropriate candidates for TAMP, and managing patients who could be
at any risk is paramount to helping underserved patient
populations, like those diagnosed with LAPC. This is especially
important given the potential of the TAMP therapy platform. The
first interim analysis in the Phase III TIGeR-PaC study was
completed in March 2023, with the Data Monitoring Committee
recommending a continuation of the study. The TIGeR-PaC study is
investigating TAMP in LAPC has a primary endpoint is a 6-month
Overall Survival benefit with secondary endpoints including reduced
side effects versus standard of care.”
TIGeR-PaC (NCT03257033) is currently enrolling unresectable LAPC
patients at several sites across the US. To learn more about the
study and the participating clinical trial sites, visit
www.clinicaltrials.gov. RenovoRx’s first product candidate,
RenovoGem™, is a novel oncology drug-delivery combination
utilizing TAMP administration technology, is currently under
investigation for therapeutic delivery of the FDA-approved
chemotherapy gemcitabine and has not been approved for commercial
sale.
About the Phase III 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 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 study is comparing
treatment with TAMP to the current standard of care of systemic
intravenous chemotherapy.
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 RenovoGem
RenovoGem™ is the first drug-device combination product
candidate that utilizes the TAMP™ therapy platform via
pressure-mediated delivery technology to deliver gemcitabine, an
FDA-approved systemic chemotherapy, locally across the arterial
wall to bathe tumor tissue in the chemotherapy. RenovoGem is
currently being evaluated in the Phase III TIGeR-PaC clinical trial
study in Locally Advanced Pancreatic Cancer (LAPC) patients.
The first interim analysis in the TIGeR-PaC study at the 26th
event of the specified events (deaths), 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 OS benefit with secondary endpoints including reduced
side effects versus standard of care. The data was first presented
at the 2023 American Association for Cancer Research Annual Meeting
in April 2023 and then as a Late Breaker Oral Presentation with
additional secondary endpoint data at the 2023 European Society of
Medical Oncology World Congress on Gastrointestinal Cancer in June
2023. The second interim analysis for this study will be triggered
by the 52nd event, which is estimated to occur in late 2024.
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 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
and collaborators 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
sub-study data described herein will not provide any benefits for
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240416471406/en/
KCSA Strategic Communications Valter Pinto, Managing Director T:
212-896-1254 renovorx@kcsa.com
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