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 initiation of the first clinical sites in Europe in
collaboration with GEICAM in Spain.
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. These sites
were recently approved by Spanish authorities, which led to site
initiation visits and training of the first sites this past
week.
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/.
According to the latest data collected by the
European Cancer Information System (ECIS), a total of 35,105 new
cases of breast cancer were diagnosed in Spain in 2022, which is
the most common cancer diagnosed in women, representing more than
30% of all cancers in women. Breast cancer is the leading cause of
death in women between the ages 35-45 in Spain with 6,836 deaths in
2022.
Professor Miguel Martin, who serves on the
FLAMINGO-01 Steering Committee, commented, "The HER2+ tumor subtype
represents around 18% of all breast cancer cases and in the past
was one of the worst prognosis. Anti-HER2 targeting therapies have
significantly reduced the relapse rate in patients with early
disease, but there is still room for improvement until we reach
zero relapse rate. The vaccine being tested in the FLAMINGO-01
study offers an excellent opportunity to reduce these relapses
without increasing the side effects of the treatment."
Dr. Martin is Head of the Clinical Oncology
Department at Gregorio Marañón General University Hospital and
Professor of Medicine at the Faculty of Medicine of the Complutense
University, both in Madrid, Spain. He is also the Chair of GEICAM
and one of its founding members. He is well known for his activity
in developing new medical strategies and participating as a
Principal Investigator in international and national clinical
trials. He has 250 articles in journals and books with a cumulative
impact factor of 1042 and h-index of 26.
Dr. Eva Carrasco, Scientific Director and CEO of
GEICAM and author of more than 70 peer-reviewed original papers in
international scientific journals, commented, "The FLAMINGO-01
study is an example of the importance of alliances between the
academic field and the pharmaceutical industry and of international
collaboration. All this favors the implementation of studies that
incorporate the perspective of clinicians from their conception,
which represents a boost to breast cancer research and the
development of new drugs for the benefit of patients."
Dr. Luis de la Cruz Merino, the national
Principal Investigator (PI) for Spain for FLAMINGO-01 commented,
"The FLAMINGO-01 trial includes patients with high-risk HER2+
breast cancer who have completed standard adjuvant treatment and
the potential beneficial effect of a vaccine based on the GP2
peptide. This peptide, associated with a response-enhancing
adjuvant (GM-CSF), appears to induce a specific antitumor immune
response in a subgroup of patients with HER2+ (HLA-A*02) breast
cancer. This trial aims to compare its efficacy versus observation,
in an adjuvant context. The mechanism of action and therapeutic
approach is very innovative, since it introduces the study of
anti-HER2 vaccines in breast cancer in the context of a randomized
phase 3 trial. The data from previous studies in HER2+ breast
cancer are very encouraging, with an adequate safety profile, so
there are reasonable expectations of success with this vaccine,
although of course it requires timely confirmation through this
type of trial."
Dr. Luis de la Cruz Merino is Professor of
Medicine, Head of the Clinical Oncology Department at Virgen
Macarena University Hospital, Seville, Spain. He specializes in
cancer and immunology and is responsible for representing all
GEICAM participating PIs from a clinical and immunotherapeutic
perspective.
CEO Snehal Patel commented, "GEICAM has been a
long-term partner of the Company. Our first protocol for
FLAMINGO-01 was developed jointly by members of GEICAM and Baylor
College of Medicine. From this relationship, we were able to reach
out to the other networks in Europe to connect academic networks
across multiple countries. We are truly grateful for the time and
commitment from the GEICAM team and look forward to working with
them in the coming quarters as we ramp up all 38 sites."
The 38 GEICAM clinical sites will be listed on
clinicaltrials.gov with an interactive map and are shown below.
Albacete
Albacete University Hospital
Complex
Alicante
Dr. Balmis General University
Hospital
Badajoz
University Hospital of Badajoz
Barcelona
Clinic Hospital of BarcelonaHospital
del Mar
Caceres
San Pedro de Alcántara Hospital
Cordoba
Reina Sofia University Hospital
Fuenlabrada (Madrid)
University Hospital of
Fuenlabrada
Galdácano
Galdakao-Usansolo Hospital
Granada
San Cecilio Clinical University
Hospital
Jaén
University Hospital of Jaén
Jerez de La Frontera
University Hospital of Jerez de la
Frontera
La Laguna (Tenerife)
University Hospital of the Canary
Islands
Lerida
Arnau de Vilanova University Hospital
of Lleida
Madrid
Gregorio Marañón General University
Hospital 12 de Octubre University HospitalFundación Jiménez Díaz
University HospitalHM Sanchinarro University HospitalInfanta Leonor
University Hospital
Majadahonda (Madrid)
Puerta de Hierro Majadahonda
University Hospital
Malaga
Regional University Hospital of
Malaga
Manresa (Barcelona)
Althaia, Manresa University Care
Network
Murcia
Morales Meseguer University General
Hospital
Virgen de la Arrixaca University
Clinic Hospital
Palma, Majorca (Balearic Islands)
Son Espases University Hospital
San Juan (Alicante)
San Juan University Hospital of
Alicante
San Sebastian
Donostia University Hospital
Sant Cugat del Valles (Barcelona)
General University Hospital of
Catalonia - Quirónsalud Group
Santa Cruz De Tenerife
Nuestra Señora de Candelaria
University Hospital
Santiago de Compostela
University Clinical Hospital of
Santiago
Seville
Virgen del Rocío University
HospitalVirgen Macarena University Hospital
Toledo
University Hospital of Toledo
Valencia
General University Hospital
Consortium of ValenciaValencian Institute of Oncology
FoundationUniversity Clinical Hospital of ValenciaArnau de Vilanova
University Hospital of Valencia
Zaragoza
Miguel Servet University Hospital
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 282,000 new
breast cancer patients and 3.8 million breast cancer survivors in
2021. 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, 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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