Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a
clinical-stage biopharmaceutical company focused on the development
of GLSI-100, an immunotherapy to prevent breast cancer recurrences
in patients who have previously undergone surgery, today provided
the following update on the Phase III clinical trial, Flamingo-01.
Data Safety Monitoring Board
(DSMB)
The Flamingo-01 DSMB met twice in 2023 and
recommended to continue the study as is without modification. No
serious adverse events related to GLSI-100 have been reported to
date.
US Clinical Sites Participating in
Flamingo-01
Approximately 30 clinical sites with 87
locations at multiple hospitals and the largest oncology network in
the US are currently recruiting patients and are listed below.
While the first site was activated in August 2022, the first
patient was screened and treated in December 2022. Other sites
enrolled their first patients in 2023 with additional sites being
activated throughout the year. The Company anticipates adding up to
an additional 10 sites in 2024, bringing the total sites in the US
to approximately 35-40 sites.
European Clinical Sites and Networks
Participating in Flamingo-01
Pending European regulatory approval, which is
expected in 2024, contracts are in place to add up to an additional
105-120 sites in Europe including Spain (38), France (21), Germany
(32), Italy (9), Poland (6), and potentially additional countries
in Europe, bringing the total number of potential sites in
Flamingo-01 to approximately 140-160 sites between the US and
Europe. With a peak enrollment estimate of approximately 2 - 4
patients per site per year, 150 active sites in Flamingo-01 could
see peak enrollment of up to 300-600 patients per year. The
logistics to supply GP2 and Leukine labeled in each language, to
collect patient samples, and to supply all other clinical supplies
have been contracted in Europe and are in the final stages of being
implemented.
European academic networks in each country are
planning to participate in Flamingo-01 and are listed below. These
networks represent the largest oncology focused hospitals and
centers in Europe, where breast cancer leaders work in a
collaborative manner to help advance promising therapies and they
hold annual scientific meetings where Flamingo-01 has been
introduced and where the company may present in the future.
GEICAM is the leading group in breast cancer
research in Spain and currently consists of more than 900 experts,
who work in more than 200 centers throughout Spain. Since its
establishment in 1995, GEICAM has carried out more than one hundred
studies in which more than 66,000 women and men have
participated.
UCGB or Unicancer is the federation of French
comprehensive cancer centers, a major player in cancer research and
a network of 20 private, non-profit healthcare centers specialized
in oncology, brought together in a health cooperation group.
GBG Forschungs GmbH is one of the world's
leading breast cancer research institutes that works together with
the academic study group German Breast Group (GBG). With more than
67,000 study participants and 3,500 new patients per year, GBG is
the largest breast cancer study group in Germany, consisting of
more than 1,000 doctors in over 800 centers.
GIM (Gruppo Italiano Mammella) is a cooperative
Italian network for breast cancer research and therapy. GIM
brings together over 150 participating centers and around 500
investigators.
SABCS Update & Flamingo-01 Steering
Committee
At the 2023 San Antonio Breast Cancer Symposium
(SABCS) and 2023 ASCO Annual Meeting, the Company met with the
Flamingo-01 Steering Committee and clinicians from the US and
various countries in Europe who are participating or planning to
participate in Flamingo-01.
The Steering Committee is comprised of the following
members:
- Dr. Mothaffar
F. Rimawi – Professor of Medicine at the Baylor College of Medicine
and Executive Medical Director and Co-Leader, Breast Cancer Program
of the Dan L Duncan Comprehensive Cancer Center
- Dr.
Francois-Clement Bidard – Professor of Medical Oncology, UVSQ/Paris
Saclay University, Head of Breast Cancer Group, Institut Curie,
Vice-Chair of the French Breast Cancer research group UCBG
(Unicancer)
- Dr. William
J. Gradishar – Professor of Medicine at the Feinberg School of
Medicine at Northwestern University, Chief of Hematology and
Oncology in the Department of Medicine, and Betsy Bramsen Professor
of Breast Oncology
- Dr. Sara A.
Hurvitz – Professor of Medicine, Head of Division of
Hematology/Oncology at University of Washington, Senior Vice
President of the Clinical Research Division at the Fred Hutchinson
Cancer Center
-
Dr. Sibylle Loibl – Professor (apl) Goethe University
Frankfurt/M, Clinical Consultant Centre for Haematology and
Oncology/Bethanien Frankfurt/M, CEO of GBG Forschungs GmbH &
Chair of the German Breast Group (GBG)
- Dr. Miguel
Martin – Professor of Medicine, Head, Medical Oncology Service,
Gregorio Marañón General University Hospital, Complutense
University, Madrid, Chairman of GEICAM
- Dr. Joyce A.
O'Shaughnessy – Celebrating Women Chair in Breast Cancer, Baylor
University Medical Center and Chair, Breast Cancer Program, Texas
Oncology, US Oncology, Dallas, Texas
- Dr. Hope S.
Rugo – Professor of Medicine and Winterhof Family Professor of
Breast Oncology and Director, Breast Oncology and Clinical Trials
Education, University of California, San Francisco, Helen Diller
Family Comprehensive Cancer Center
- Dr. Laura M.
Spring – Assistant Professor, Medicine, Harvard Medical School,
Attending Physician, Medical Oncology, Massachusetts General
Hospital
The Steering Committee discussed unpublished
data, including new research the Company conducted in 2023, that
suggests that GP2 may bind to various HLA types and not just
HLA-A*02, in addition to discussing the prior data that supports
the third arm of the Phase III trial, where 100 non-HLA-A*02
patients are currently planned to be enrolled. The Steering
Committee agreed to expand this third arm to 250 patients. Given
the encouraging data and the Steering Committee's guidance, the
Company will amend the Flamingo-01 protocol to allow up to 250
patients to enroll in the open-label arm of the study.
Dr. Rimawi, Chair of the Steering Committee,
commented, "Among my peers, the level of interest in the
Flamingo-01 trial is very high. The new sites in Europe will make
significant contributions to the trial in terms of patient
enrollment as well as overall conduct of the trial. The expansion
of the unblinded non-HLA-A*02 arm is also significant as it
reflects the interest among patients and investigators in exploring
the activity of GLSI-100 in these patients, which may expand the
patient population who could benefit from this exciting
vaccine."
Dr. Jaye Thompson, VP Clinical and Regulatory
Affairs, commented, "We welcome the new US and European members to
the Steering Committee and are honored to be receiving their
continued guidance in the development of GP2 and oversight of
Flamingo-01. The Company spent considerable time in Europe in 2023
planning and organizing in each country. We have trained the
country specific research networks in each country with the
assistance of the key opinion leaders of these countries and worked
closely as a group as we applied through a central European
regulatory process to allow Flamingo-01 to expand into Europe. We
expect to be able to expand the third arm to 250 patients in a
cost-effective manner as 85-100% of the global sites plan to enroll
into the third arm. We have also seen an increase in interest from
third parties in India and China, countries with the largest
prevalence of breast cancer, who are interested in further
developing GP2 for their patient populations."
Planned Interim Analysis
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 the third arm.
For the HLA-A*02 randomized arms, 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.
CEO Snehal Patel commented, "With the addition
of the European sites and approximately 150 total sites, peak
enrollment rates could be reached by the end of 2024 allowing for a
refinement in the interim analysis. Currently, enrollment will
likely end before the interim analysis is triggered by 14 events.
However, the interim analysis could be modified such that an
additional sizing interim analysis is conducted before enrollment
ends to reaffirm the size of the 2 randomized arms. While the
hazard ratio of 0.3 assumes that the recurrence rate of the treated
arm will be 30% of the recurrence rate in the placebo arm and thus
a 70% reduction in recurrence rate, and while the Phase II trial
showed even greater reduction in recurrence rate, we are likely to
see recurrences in the treated arm of the Phase III trial and have
designed the trial accordingly. Using the early Phase III trial
data to reaffirm the size of the arms of the Phase III trial may be
the best information we could use to reduce risk and improve the
chances of success of Flamingo-01."
Mr. Patel further added, "While we may have
high expectations for the interim analysis midway through the
trial, Roche's successful Herceptin and Kadcyla products reduced
recurrences by only 50%, while still requiring that all HER2
positive patients be treated. Thus, we believe a similar clinical
outcome for Flamingo-01 could occur and could generate similar
returns to stakeholders as did Roche's franchise drugs, which at
their peak significantly exceeded $5 billion in revenue per
year."
Preparation for Filing of BLA in the
US
In addition to the submission of the Phase III
clinical data, submitting commercial manufacturing data and study
reports on the prior clinical trials will be critical to the filing
of a BLA for GLSI-100 and for regulatory filings in other
countries.
Commercial Manufacturing: The
first 3 commercial lots of GP2 active ingredient were completed and
released in 2023, representing an important step towards
commercialization. The 3 lots in total could be used to prepare
approximately 200,000 doses of GP2. In 2024, the first of 3
commercial lots filling GP2 into vials for commercial sale or for
clinical use is planned. Data on these commercial lots will be
submitted to the FDA in the US and other regulatory agencies in
Europe or elsewhere when a marketing application is filed seeking
approval to sell GP2 in these respective markets.
Phase II Clinical Trial Study
Report: The Company is preparing a comprehensive study
report of the Phase II trial for the FDA prior to the filing of a
BLA. This report will include the patients with breast cancer
recurrences, the last known date of patients who did not recur
(censoring data), the adverse events, immune responses, and other
final study report analyses. This report will serve to complement
the Phase III data and to provide a drug product dossier that can
also be submitted to regulatory agencies in other countries for
marketing approval. The use of GM-CSF as an adjuvant in GLSI-100
may also be included in the dossier as GM-CSF is only commercially
available in the US at this time.
Mr. Patel commented, "We have experienced
significant interest from investors, strategics, analysts, and
regulators in the 5 year follow-up data we published and the 3 and
4 year follow-up data independently published by the clinical
investigators. The differences between these publications can be
best explained by the increased maturity of the data as each year
progressed. In all 3 publications, no recurrences or a 100%
reduction in recurrence rate, were reported in the sub-population
that the Flamingo-01 design has been based on and any differences
between the number of patients in the treated or placebo groups has
been shown to be immaterial."
The Company did not have responsibility for the
conduct of the trial or for the data from the Phase II trial. After
the trial had already started, the Company received the rights to
the Phase II trial data pursuant to a license agreement with the
Henry Jackson Foundation (HJF) that entitled the Company to all of
the GP2 data from the Phase II trial and all prior trials, but did
not provide the Company with the ability to participate in the
Phase II trial as a regulatory clinical sponsor. The lead
clinicians and HJF were responsible for project and site
management, medical monitoring, data monitoring of case report
forms (CRFs), correspondence with the FDA, and creation, data entry
and management of the database. The Company was provided study
updates but was not provided an opportunity to participate in any
of the above activities or to review the publications of the 3 and
4 year follow-up data by the lead clinicians. Thus, the
comprehensive study report will rely on cooperation from HJF and
the clinical sites who are responsible for providing the final data
accurately to the Company.
The Company is currently comparing the final
CRFs and database provided by HJF and has noted the following
inconsistencies as the comprehensive study report is being
prepared. The lead clinicians reported in an annual report to the
FDA and in their publication of 4 year follow-up data a 6th
recurrence in the HER2 positive control arm of the study. The
Company conservatively chose not to report this 6th recurrence
since it was not reported in the data provided by HJF, even though
adding this recurrence to the control arm would significantly lower
the p-value and improve the evidence of efficacy of GLSI-100. As a
result of detailed due diligence, the Company became aware in Q4 of
2023 of a potential recurrence in the HER2 positive treated arm.
This patient was not reported as a recurrence in the database, on a
CRF that should be used for a recurrence, in reports from the lead
clinicians to the FDA, or in the 3 or 4 year follow-up data
published by the lead clinicians. Some CRFs report a recurrence,
but the critical CRF that confirms a recurrence was not completed
or entered into the database provided by HJF. The Company has since
initiated an effort to confirm with HJF and the clinicians who
treated this patient the status of this patient, and if the final
CRFs and database should be modified. It appears that this patient,
who had completed treatment with GLSI-100, experienced a local
recurrence that responded well to additional treatment and survived
without additional evidence of disease or distant metastasis for
the duration of study follow-up. Any discrepancies noted to date in
the review of the censoring date recorded in the database do not
materially change the study results and the median duration of
follow-up remains 5 years.
Mr. Patel added, "While a recurrence in the
control arm would decrease the p-value and still result in a 100%
reduction in the recurrence rate, a recurrence in the treated arm
would increase the p-value and would result in an 80% reduction in
the recurrence rate. In either case, we believe that the reduction
in recurrence rate is clinically meaningful and substantial
compared to the approximately 20-50% reduction in recurrences of
all other approved breast cancer drugs for this patient population.
These findings have not materially affected the power of the Phase
III study as the assumptions for that design were selected
conservatively."
Additional Clinical Trials Under
Consideration
The following trials are under consideration, pending additional
funding and resources:
- Phase
IIb trial to add an additional 5 years of follow-up to the prior
Phase IIb trial: If possible, extending the follow-up
period of the prior Phase IIb trial to up to 10 years may increase
the understanding of the length of protection offered by GP2 and
the need for additional boosters after the current booster regimen
ends. This data may also shed some insight on how to optimize
vaccination, how to vaccinate the 3 million survivors in the U.S.
who are many years removed from adjuvant treatment, and how to
vaccinate long term metastatic breast cancer survivors. Such a
trial extension would require a new follow-up protocol and the
cooperation of clinicians and patients who participated in the
prior Phase II trial.
- Phase
II/III trial of all low risk HER2 positive patients not eligible
for Flamingo-01: If possible, the Company could leverage
the current trial infrastructure in the US and Europe to
potentially treat all HER2 positive patients and not just those who
are high-risk, which is the current design of Flamingo-01. Some
patients in the prior Phase II trial were low-risk, which suggests
that GP2 may also work in the low-risk population. This trial would
be large and lengthy due to fewer recurrence events, but starting
it now would be cost effective given the 150 sites which would have
access to these patients.
Mr. Patel further commented, "If successful,
vaccinating HER2 positive patients who are long term survivors or
are at low risk for recurrence could more than double the patient
population being pursued in Flamingo-01. Low HER2 breast cancer
patients and HER2 positive patients in other cancers also remain
possible patient populations to pursue in the future, especially in
combination with checkpoint inhibitors and Herceptin antibody drug
conjugates."
New Intellectual Property
In the first quarter of 2023, a new patent
application was filed with regards to the use of GLSI-100 to
reverse a suppressed immune state and to activate an immune
response against HER2 positive cancer cells if they reappear. Plans
are in place to potentially file additional patent applications
with regards to GP2 manufacturing, pharmacy, or injection
processes. The Company is developing an assay that may be
applicable to the manufacturing of GP2 and is exploring alternative
formulations to minimize the reconstitution process in the
pharmacy, both of which may provide additional patent
opportunities.
2023 Corporate Events
The Company's events in 2023 are listed below
and on the events calendar (view here), and for the first time
included 3 invitations to present at scientific and clinical
conferences, a recognition of the promising GP2 clinical data and
the potential of Flamingo-01: Think Tank (a collaborative
conference with research and clinical experts in breast cancer),
Hawaii Breast (featuring the majority of US KOLs), and the 16th
International Symposium on Translational Research in Oncology
(featuring European scientific and clinical academia).
- Dec 15, 2023 – 2023 Annual Meeting of Stockholders
- Dec 5 - 9, 2023 – 2023 San Antonio Breast Cancer Symposium
(SABCS)
- Nov 6 - 8, 2023 – BIO-Europe Fall 2023
- Oct 20 - 22, 2023 – European Society for Medical Oncology
(ESMO) Congress 2023
- Oct 7, 2023 – 2023 Komen Houston Race for the Cure
- Sep 27 - 29, 2023 – 16th International Symposium on
Translational Research in Oncology
- Sep 11 - 13, 2023 – H.C. Wainwright 24th Annual Global
Investment Conference
- Aug 16 - 19, 2023 – Hawaii Breast 2023
- Jun 5 - 8, 2023 – BIO 2023 International Convention
- Jun 2 - 6, 2023 – 2023 American Society of Clinical Oncology
(ASCO) Annual Meeting
- May 11 - 13, 2023 – European Society for Medical Oncology
(ESMO) Breast Cancer 2023
- Apr 15 - 19, 2023 – American Association for Cancer Research
(AACR) Annual Meeting 2023
- Feb 6 - 9, 2023 – 2023 BIO CEO & Investor Conference
- Jan 9 - 13, 2023 – Breast Cancer Think Tank Conference
List of US Clinical Sites Participating
in Flamingo-01 Phase III Clinical Trial
Patients who are interested in participating in the Flamingo-01
Phase III clinical trial can learn more about the study at
www.clinicaltrials.gov/study/NCT05232916. Each clinical trial site
location is listed on the website under "Contacts and Locations"
with a new feature showing each site on a map. Patients should
contact a participating clinical trial site near them or
Flamingo-01@GreenwichLifeSciences.com for screening. The current
listing of US sites from the clinicaltrials.gov website with email
contact information for some sites is shown below and will be
continually updated during the trial. Additional sites are planned
to be opened at large hospitals in Boston, Philadelphia, and
Baltimore/Washington DC. |
Arizona |
Arizona Oncology Associates, PC - HOPE |
Tucson, Arizona, United States, 85745 |
Contact: Stacey Kimbell, R.N. Stacey.Kimbell@usoncology.com |
Principal Investigator: Aisha Ahmed, MD |
|
California |
Comprehensive Blood and Cancer Center |
Bakersfield, California, United States, 93309 |
Principal Investigator: Ravindranath Patel, MD |
Providence Medical Foundation |
Fullerton, California, United States, 92835 |
Contact: Rebeca Sanchez 714-446-5177
rebeca.sanchez2@providence.org |
Contact: Linda Gozar linda.gozar@stjoe.org |
Principal Investigator: Monica Lee, MD |
University of Southern California |
Los Angeles, California, United States, 90033 |
Contact: Kimberly Arieli Kimberly.Arieli@med.usc.edu |
Principal Investigator: Danielle Sterrenberg, MD |
University of California, Los Angeles |
Los Angeles, California, United States, 90404 |
Contact: Monica Rocha MPRocha@mednet.UCLA.edu |
Principal Investigator: Aashini Master |
Stanford Women's Cancer Center |
Palo Alto, California, United States, 74304 |
Contact: Sasha Madan madan2@stanford.edu |
Principal Investigator: Fauzia Riaz, MD |
University of California, San Francisco Helen Diller Family Cancer
Center |
San Francisco, California, United States, 94158 |
Principal Investigator: Hope Rugo, MD |
Torrance Memorial Physicians Network |
Torrance, California, United States, 90505 |
Contact: Jessica Yoshinaga jyoshinaga@mednet.ucla.edu |
Principal Investigator: David Chan, MD |
PIH Hospital - Whittier |
Whittier, California, United States, 90602 |
Contact: Kristine Bradbury Kristine.Bradbury@pihhealth.org |
Principal Investigator: Lisa Wang, MD |
|
Colorado |
Rocky Mountain Cancer Centers |
Denver, Colorado, United States, 80220 |
Contact: Jennifer Hege Jennifer.Hege@USOncology.com |
Principal Investigator: Mabel Mardones, MD |
|
Connecticut |
Yale University |
New Haven, Connecticut, United States, 06511 |
Principal Investigator: Michael DiGiovanna, MD |
|
Florida |
University of Miami |
Coral Gables, Florida, United States, 33146 |
Contact: Maria Ferrer-Guerra mtf89@med.miami.edu |
Principal Investigator: Mauricio Escobar, MD |
Orlando Health Cancer Institute |
Orlando, Florida, United States, 32806 |
Contact: Melinda Porter Janice.Porter@orlandohealth.com |
Principal Investigator: Nikita Shah, MD |
Moffitt Cancer Center |
Tampa, Florida, United States, 33612 |
Contact: Julian Guerrero Julian.Guerrero@Moffitt.org |
Principal Investigator: Aixa Soyano, MD |
|
Illinois |
Northwestern University |
Chicago, Illinois, United States, 60611 |
Contact: clinicaltrials@northwestern.edu |
Principal Investigator: William Gradishar, MD |
|
Maryland |
Maryland Oncology Hematology (USOR) |
Annapolis, Maryland, United States, 21401 |
Contact: Gloria Seho-Ahiable
Gloria.Seho-Ahiable@USOncology.com |
Principal Investigator: Jeanine Werner, MD |
|
Missouri |
Washington University Siteman Cancer Center |
Saint Louis, Missouri, United States, 63110 |
Principal Investigator: Faisal Fa'ak, MD |
|
Nebraska |
Nebraska Cancer Specialists (USOR) |
Omaha, Nebraska, United States, 68114 |
Contact: Heather Cordes hcordes@nebraskacancer.com |
Principal Investigator: Mary Wells, MD |
University of Nebraska Medical Center |
Omaha, Nebraska, United States, 68198 |
Principal Investigator: Jairam Krishnamurthy, MD |
|
Nevada |
Comprehensive Cancer Centers of Nevada |
Henderson, Nevada, United States, 89052 |
Contact: Lindsay Kondo lindsay.kondo@usoncology.com |
Principal Investigator: Stephani Christensen, MD |
|
New York |
New York Oncology |
Clifton Park, New York, United States, 12065 |
Contact: Josephine Faruol josephine.faruol@usoncology.com |
Principal Investigator: Karen Tedesco, MD |
Columbia University |
New York, New York, United States, 10032 |
Contact: cancerclinicaltrials@CUMC.Columbia.edu |
Principal Investigator: Julia McGuinness, MD |
Stony Brook University |
Stony Brook, New York, United States, 11794 |
Contact: Pushpa Talanki Pushpa.talanki@stonybrookmedicine.edu |
Contact: Jules Cohen jules.cohen@stonybrookmedicine.edu |
Principal Investigator: Jules Cohen, MD |
|
Ohio |
Oncology Hematology Care Clinical Trials |
Cincinnati, Ohio, United States, 45211 |
Contact: Douglas Hart Douglas.Hart@usoncology.com |
Principal Investigator: Patrick Ward, MD |
|
Oregon |
Compass Oncology (USOR) |
Tigard, Oregon, United States, 97223 |
Contact: Jennifer Thompson Jennifer.Thompson@usoncology.com |
Principal Investigator: Jay Andersen, MD |
|
Pennsylvania |
Redeemer Health |
Meadowbrook, Pennsylvania, United States, 19046 |
Contact: Nadine Varney 215-544-5832 nvarney@holyredeemer.com |
Principal Investigator: Pallav Mehta, MD |
|
Texas |
Texas Oncology - Austin |
Austin, Texas, United States, 78745 |
Contact: Sara Manning Sara.Manning@usoncology.com |
Principal Investigator: Debra A Patt, MD |
Texas Oncology - Dallas (USOR) |
Dallas, Texas, United States, 75246 |
Contact: Christine Terraciano
Christine.Terraciano@usoncology.com |
Principal Investigator: Cynthia Osborne, MD |
Texas Oncology - Dallas Presbyterian Hospital |
Dallas, Texas, United States, 75231 |
Contact: Nancy Jones nancy.jones@usoncology.com |
Principal Investigator: Kristi McIntyre, MD |
The University of Texas Southwestern Medical Center |
Dallas, Texas, United States, 75390 |
Principal Investigator: Nisha Unni, MD |
Baylor College of Medicine |
Houston, Texas, United States, 77057 |
Contact: Rebecca Hildebrandt Rebecca.Hildebrandt@BCM.edu |
Principal Investigator: Mothaffar Rimawi, MD |
Texas Oncology San Antonio (USOR) |
San Antonio, Texas, United States, 78240 |
Contact: Shannon Syring Shannon.Syring@usoncology.com |
Principal Investigator: Emmalind Aponte, MD |
Texas Oncology - Gulf Coast |
Sugar Land, Texas, United States, 77479 |
Contact: Melissa Howell Melissa.Howell@usoncology.com |
Principal Investigator: Jorge Darcourt, MD |
Texas Oncology - Tyler (USOR) |
Tyler, Texas, United States, 75702 |
Contact: Shelly Maxfield Shelly.Maxfield@USOncology.com |
Principal Investigator: Nanna Sulai, MD |
|
Utah |
University of Utah Huntsman Cancer Institute |
Salt Lake City, Utah, United States, 84112 |
Principal Investigator: Mei Wei, MD |
|
Virginia |
Virginia Cancer Specialists |
Fairfax, Virginia, United States, 22031 |
Contact: Carrie Friedman Carrie.Friedman@USOncology.com |
Principal Investigator: Shruti Tiwari, MD |
|
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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