Greenwich LifeSciences Flamingo-01 Manufacturing & Protocol Accepted by European Regulators
February 22 2024 - 5:00AM
Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a
clinical-stage biopharmaceutical company focused on its Phase III
clinical trial, Flamingo-01, which is evaluating GLSI-100, an
immunotherapy to prevent breast cancer recurrences in patients who
have previously undergone surgery, today provided the following
update on the expansion of the clinical trial into Europe.
The Company's application to expand Flamingo-01
into Europe has been reviewed by European Medicines Agency (EMA)
through EMA's Clinical Trials Information System (CTIS). The
Company was informed that the manufacturing, non-clinical,
clinical, statistical, and regulatory sections of its application
are acceptable and the regulators' requests for information have
been addressed. The regulators have thus approved the clinical
trial, marking a major milestone for the Company.
The 5 individual countries in Europe will now
make a final determination, and if acceptable, they will allow the
first group of approximately 105 sites in Europe to begin
initiation and activation. Once an individual site has been
activated patients can be screened and enrolled.
CEO Snehal Patel commented, "Our interactions
with EMA and the 5 participating countries through the CTIS process
provided great insight into EMA's expectations for a marketing
license application in Europe for GLSI-100. We will continue the
dialogue with EMA regulators as we operate Flamingo-01 in Europe,
which will help us prepare for an EU licensing application in the
future in parallel to filing a BLA in the US."
About Flamingo-01 and
GLSI-100
Flamingo-01 (NCT05232916) is a Phase III
clinical trial designed to evaluate the safety and efficacy of
GLSI-100 (GP2 + GM-CSF) in HER2/neu positive breast cancer patients
who had residual disease or high-risk pathologic complete response
at surgery and who have completed both neoadjuvant and
postoperative adjuvant trastuzumab based treatment. The trial is
led by Baylor College of Medicine and currently includes US
clinical sites from university-based hospitals and cooperative
networks with plans to expand into Europe and to open up to 150
sites globally. In the double-blinded arms of the Phase III trial,
approximately 500 HLA-A*02 patients will be randomized to GLSI-100
or placebo, and up to 250 patients of other HLA types will be
treated with GLSI-100 in a third arm. The trial has been designed
to detect a hazard ratio of 0.3 in invasive breast cancer-free
survival, where 28 events will be required. An interim analysis for
superiority and futility will be conducted when at least half of
those events, 14, have occurred. This sample size provides 80%
power if the annual rate of events in placebo-treated subjects is
2.4% or greater.
For more information on Flamingo-01, please
visit the Company's website here and clinicaltrials.gov here.
Contact information and an interactive map of the majority of
participating clinical sites can be viewed under the "Contacts
and Locations" section. Please note that the interactive map is not
viewable on mobile screens. Related questions and participation
interest can be emailed
to: flamingo-01@greenwichlifesciences.com
About Breast Cancer and
HER2/neu Positivity
One in eight U.S. women will develop invasive
breast cancer over her lifetime, with approximately 282,000 new
breast cancer patients and 3.8 million breast cancer survivors in
2021. HER2/neu (human epidermal growth factor receptor 2) protein
is a cell surface receptor protein that is expressed in a variety
of common cancers, including in 75% of breast cancers at low (1+),
intermediate (2+), and high (3+ or over-expressor) levels.
About Greenwich LifeSciences,
Inc.
Greenwich LifeSciences is a clinical-stage
biopharmaceutical company focused on the development of GP2, an
immunotherapy to prevent breast cancer recurrences in patients who
have previously undergone surgery. GP2 is a 9 amino acid
transmembrane peptide of the HER2/neu protein, a cell surface
receptor protein that is expressed in a variety of common cancers,
including expression in 75% of breast cancers at low (1+),
intermediate (2+), and high (3+ or over-expressor) levels.
Greenwich LifeSciences has commenced a Phase III clinical trial,
Flamingo-01. For more information on Greenwich LifeSciences, please
visit the Company's website at www.greenwichlifesciences.com and
follow the Company's Twitter at
https://twitter.com/GreenwichLS.
Forward-Looking Statement
Disclaimer
Statements in this press release contain
"forward-looking statements" that are subject to substantial risks
and uncertainties. All statements, other than statements of
historical fact, contained in this press release are
forward-looking statements. Forward-looking statements contained in
this press release may be identified by the use of words such as
"anticipate," "believe," "contemplate," "could," "estimate,"
"expect," "intend," "seek," "may," "might," "plan," "potential,"
"predict," "project," "target," "aim," "should," "will," "would,"
or the negative of these words or other similar expressions,
although not all forward-looking statements contain these words.
Forward-looking statements are based on Greenwich LifeSciences
Inc.'s current expectations and are subject to inherent
uncertainties, risks and assumptions that are difficult to predict,
including statements regarding the intended use of net proceeds
from the public offering; consequently, actual results may differ
materially from those expressed or implied by such forward-looking
statements. Further, certain forward-looking statements are based
on assumptions as to future events that may not prove to be
accurate. These and other risks and uncertainties are described
more fully in the section entitled "Risk Factors" in Greenwich
LifeSciences' Annual Report on Form 10-K for the year ended
December 31, 2022 and other periodic reports filed with the
Securities and Exchange Commission. Forward-looking statements
contained in this announcement are made as of this date, and
Greenwich LifeSciences, Inc. undertakes no duty to update such
information except as required under applicable law.
Company ContactSnehal
PatelInvestor RelationsOffice: (832) 819-3232Email:
info@greenwichlifesciences.com
Investor & Public Relations Contact
for Greenwich LifeSciencesDave GentryRedChip Companies
Inc.Office: 1-800-RED CHIP (733 2447)Email: dave@redchip.com
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