Company to Present Interim Analysis Secondary
Endpoint Data Including Progression-free Survival from Phase III
TIGeR-PaC Study, a Multi-center Open-label Study Evaluating
RenovoGem™ to Treat Locally Advanced Pancreatic Cancer (LAPC)
RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a
clinical-stage biopharmaceutical company developing targeted
combination therapies, today announced the acceptance of a
late-breaking oral presentation for its lead product candidate
RenovoGem, in the treatment of locally advanced pancreatic cancer
(LAPC), at the upcoming ESMO World Congress on Gastrointestinal
Cancer (ESMO GI). The conference will be held June 28 – July 1,
2023, in Barcelona, Spain, with the presentation scheduled for
Thursday, June 29, 2023, at 8:50 AM CEST.
The presentation will feature new secondary endpoint data from
the first interim analysis triggered in the Phase III TIGeR-PaC
study – a multi-center, open-label clinical trial. The study is
evaluating RenovoGem to treat LAPC through RenovoRx’s proprietary
trans-arterial micro-perfusion (TAMP™) drug-delivery platform of
FDA-approved gemcitabine.
The Phase III study has a primary endpoint of overall survival
and several secondary endpoints, including progression-free
survival (PFS) and quality of life. The study is designed to
randomize 114 patients. Final analysis will be conducted after 86
events (deaths) from the stereotactic body radiation therapy (SBRT)
population. The study includes two planned interim analyses, the
first upon 30% (26 of 86) of total events and the second upon 60%
(52 of 86) of total events.
Data from the planned first interim analysis of the Phase III
TIGeR-PaC study, presented at recent American Association of
Clinical Research (AACR) 2023, demonstrated a 6-month median
overall survival difference between the test arm (RenovoGem) and
control arm (standard of care gemcitabine and Abraxane) along with
a 65% reduction in adverse events.
"We are thrilled to announce that Dr. Michael J. Pishvaian,
Principal Investigator, will present new secondary endpoint data
from the interim analysis in our pivotal study at the upcoming ESMO
GI,” said Shaun Bagai, CEO, RenovoRx. “This data will notably
include PFS from the Phase III study, which has historically been
used as a registrational endpoint in FDA New Drug Applications both
in accelerated and traditional approvals. We look forward to
continued engagement with leading oncologists in the field as we
advance RenovoGem and our delivery platform’s potential to benefit
cancer patients.”
Presentation Details:
Abstract Title: “The Phase 3
study Targeted Intra-Arterial Gemcitabine vs. Continuation of IV
Gemcitabine plus Nab-Paclitaxel following Induction with Sequential
IV Gemcitabine plus Nab-Paclitaxel and Radiotherapy for Locally
Advanced Pancreatic Cancer (TIGeR-PaC) trend toward a survival
benefit at its first interim analysis”
Abstract Number: LBA-1
Presenting Author: Michael Jon
Pishvaian, M.D., Ph.D., Director of Gastrointestinal, Developmental
Therapeutics and Clinical Research Programs, Associate
Professor of Oncology, John Hopkins School of Public Health
Presentation Date and Time:
Thursday, June 29, 2023, at 8:50 – 9:00 AM CEST
Data presented at the conference will be available to view in
the Clinicians section of the RenovoRx website following the ESMO
GI Conference.
The treatment of LAPC remains a clinical challenge with a median
survival of 15-18 months from diagnosis. RenovoGem™ delivers
gemcitabine directly to the tumor site, enhancing the therapeutic
effectiveness while potentially minimizing the systemic side
effects commonly associated with traditional chemotherapy
intravenous administration, and potentially improving patient
outcomes. RenovoGem is currently under investigation for the
intra-arterial delivery of gemcitabine and has not been approved
for commercial sale.
TIGeR-PaC 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
https://renovorx.com/clinical-trial/.
About RenovoRx, Inc.
RenovoRx is a clinical-stage biopharmaceutical company
developing targeted combination therapies for high unmet medical
needs. The Company’s proprietary Trans-Arterial Micro-Perfusion
(TAMP™) therapy platform is designed to bypass traditional systemic
delivery methods and ensure precise therapeutic delivery to a
target tissue, while minimizing a therapy’s systemic toxicities.
RenovoRx’s unique approach to drug-delivery offers the potential
for increased treatment safety, tolerance, and wider therapeutic
windows. The Company’s lead product candidate, RenovoGem™, combines
gemcitabine with the company’s patented delivery system and is
regulated by FDA under its 505(b)2 pathway. RenovoGem is currently
in a Phase III clinical trial (TIGeR-PaC) for the treatment of
LAPC. RenovoRx is committed to transforming the lives of patients
by delivering innovative solutions to change the current paradigm
of cancer care. 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 RenovoTAMP®, RenovoCath® or RenovoGemTM 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
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/20230525005267/en/
Investor Contact: KCSA Strategic Communications Valter Pinto or
Jack Perkins T: 212-896-1254 renovorx@kcsa.com
Media Contact: Kimberly Ha T: 917-291-5744
kimberly.ha@kkhadvisors.com
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