Greenwich LifeSciences Flamingo-01 Phase III Clinical Trial Approved to Expand into Five Largest European Countries
February 27 2024 - 6:00AM
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, 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 formally approved by Spain, France, Germany,
Italy, and Poland. The academic networks participating in each
country are Geicam (Spain), Unicancer (France), GBG (Germany), GIM
(Italy), and a network of Polish sites. With this final approval,
regulators have cleared the way to activate 105 sites as soon as
site contracts and site initiation visits are completed. Site
initiation visits have been scheduled as early as the week of March
4, 2024.
CEO Snehal Patel commented, "We have been
planning this expansion for over 2 years and are thrilled to be
making GLSI-100 available to patients in Europe in these major
countries with a total population of approximately 300 million. The
interest in developing a vaccine to prevent the recurrence of
breast cancer is very high in the European clinical and academic
community, especially given the promising efficacy and safety
profile from the prior GLSI-100 trials. We look forward to working
very closely with our European colleagues and will start by
training site staff, pharmacists, and nurses. We hope to open sites
as quickly as possible, while applying to open additional sites in
the approved countries and potentially adding additional countries
in Europe."
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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