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 announced
the following update of the expansion of clinical sites into Spain.
As previously announced, the Company has
partnered with GEICAM, the largest academic breast cancer research
network in Spain, where 38 hospitals have agreed to participate in
FLAMINGO-01.
To date, approximately 30 out of 38 sites have
conducted site initiation visits (SIVs). An SIV is followed by site
activation, HLA type screening, and study treatment. To date
approximately 19 sites have been activated. Multiples sites have
begun screening patients for HLA type and have started treating
patients. The Company has visited and trained in-person at
approximately 26 out of the 38 sites to ensure optimal treatment at
each site. In the coming months, GEICAM hopes to complete the
remaining SIVs and the Company hopes to visit the remaining
sites.
"It has been an honor to meet with the excellent
study staff, investigators and GEICAM staff across Spain. Their
expertise and interest in FLAMINGO-01 is encouraging for the
success of the study. We look forward to seeing patient recruitment
increase in Spain as other countries in the European Union become
active," remarked Jaye Thompson, VP of Clinical and Regulatory
Affairs.
CEO Snehal Patel commented, "The remarkable
progress in Spain, in just May through July, is a testament to the
commitment of GEICAM and our team to collaborate and to train the
sites together, which we hope will lead to high quality treatment
of patients. With just these 30 sites, we have approximately
doubled the number of sites that we have opened in the US."
The Company may provide updates on the status of
other countries in Europe as the clinical trial is expanded to up
to 150 sites in the US, Spain, Italy, France, Germany, and
Poland.
About GEICAM
Founded in 1995, GEICAM is a not-for-profit
organization leading academic breast cancer research in Spain. It
has conducted more than 140 studies involving more than 67,000
women and men and is comprised of more than 900 experts based in
over 200 Spanish hospitals. Its mission is to promote independent
clinical, epidemiological, and translational research in oncology,
with a multidisciplinary approach and under quality criteria, to
improve health outcomes, as well as prevention, medical education,
and the dissemination of the knowledge of this disease to patients
and general society. More information on GEICAM can be found at
https://www.geicam.org/.
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 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 300,000 new
breast cancer patients and 4 million breast cancer survivors. HER2
(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 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, 2023 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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