- The GP2 Phase III clinical trial design was
presented in a poster during the 2021 American Society of Clinical
Oncology (ASCO) Annual Meeting, providing an open label arm and
potentially valuable data that can be analyzed and presented at any
time starting in 2022. The interim analysis of the blinded,
randomized pivotal arms will be reported midway through the trial
approximately 3 years from the start of the trial.
- The GP2 Phase III clinical trial will be
called FLAMINGO-01 and the combination of GP2 + GM-CSF will be
called GLSI-100.
- At this time, at least 15 large university
based hospitals and 4 clinical cooperative networks covering US and
international sites are in discussions with the Company about
participating in FLAMINGO-01 in addition to Baylor College of
Medicine, the lead site. Study site recruitment will continue into
2022.
- The Company is currently completing the
last steps to release GLSI-100 drug product vials to the clinical
sites and to open clinical sites so patients can be screened,
tested for HLA, and then enrolled and treated with GLSI-100 or
placebo.
Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), 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, today provides an
update on the upcoming Phase III clinical trial FLAMINGO-01.
CEO Snehal Patel commented, “Our objective is to make GLSI-100
available to as many patients as possible as soon as possible. This
will include opening FLAMINGO-01 in many clinical sites that are
geographically situated to maximize access for patients. We
continue to hear from patients interested in participating in our
GLSI-100 trial and expect to be able to refer them to participating
sites as appropriate. We recommend that patients or their
physicians contact a participating clinical trial site near them
once these sites have been opened and we communicate the
participating sites to the public. We have been pleasantly
surprised by the level of interest in our trial by major teaching
hospitals led by breast cancer KOLs. While these sites may lead to
strong enrollment, they may also lead to additional collaboration
designed to optimize treatment with GLSI-100 in subsequent trials.
We will be meeting with these KOLs at the upcoming in-person San
Antonio Breast Cancer Symposium in December 2021 and look forward
to opening the first sites and the trial soon thereafter.”
The trial is titled:
"A Randomized, Multicenter, Placebo-controlled, Phase 3 Study to
Evaluate the Efficacy and Safety of HER2/neu Peptide GLSI-100 (GP2
+ GM-CSF) in HER2/neu Positive Subjects with Residual Disease or
High-Risk PCR after both Neoadjuvant and Postoperative Adjuvant
Trastuzumab-based Therapy (FLAMINGO-01)".
Vice President of Clinical and Regulatory Affairs, Dr. Jaye
Thompson further commented, “The trial has been designed with an
open label arm designed to provide a continual flow of data that
can be publicly released, while preserving the blinding and
randomization of the pivotal arms of the trial. Thus, we plan to
continue to publish Phase IIb and Phase III trial data at
conferences throughout the conduct of the Phase III study. The
projected timeline to report the interim analysis data will depend
on the rate of recurrences in both arms of the trial, but is
estimated to be approximately 3 years from the time of first
patient treatment. We are also making a major investment in
commercial manufacturing now, which may allow for submission of a
Biologics Licensing Application (BLA) to the FDA for conditional
marketing approval of GLSI-100 based on the results of the interim
analysis.”
Design features of the FLAMINGO-01 Phase III trial include:
- The Company has added more frequent
sampling and testing of patients over longer time frames and plans
to utilize improved technologies to analyze immune response.
- A third open-label arm treating up to 100
patients has been added to the Phase III trial to test GLSI-100 in
HLA types other than HLA-A*02 and to assess immune response and
clinical outcome. This third arm will function similar to a Phase
II trial, thus creating potential for early immune response data
analysis and proof of concept in other HLA types, which would
expand GLSI-100’s market by HLA type from 50% up to 80% or
more.
- The recurrence rate data from the third
arm, along with injection site reaction and immune response data
from any arm across all HLA types will be available for analysis
throughout the study and may provide meaningful data until the
interim analysis of the recurrence rate data from the blinded
HLA-A*02 arms of the Phase III trial is completed.
- In both of the blinded, randomized,
placebo-controlled HLA-A*02 arms of the Phase III trial, the
approximately 500 patient trial design will include an event-driven
interim analysis for superiority or futility. This analysis will be
conducted when approximately half of the expected breast cancer
recurrences or 14 events have occurred. While a hazard ratio of HR
= 0 was observed in the Phase IIb trial, a more conservative HR =
0.3 was selected for the sizing of the Phase III trial with plans
in place to adaptively adjust the size of the trial as
necessary.
About FLAMINGO-01 and GLSI-100
The Phase III clinical trial will be called FLAMINGO-01 and the
combination of GP2 + GM-CSF will be called GLSI-100. The Phase III
trial is comprised of 2 blinded, randomized, placebo-controlled
arms for approximately 500 HLA-A*02 patients and 1 open label arm
of up to 100 patients for all other HLA types. An interim analysis
has been designed to detect a hazard ratio of 0.3 in IDFS, 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. The
trial is currently being registered on clinicaltrials.gov and the
link and trial identifier will be published shortly. For future
updates about FLAMINGO-01 please visit the Company’s clinical trial
tab at https://greenwichlifesciences.com/clinical-trials/.
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. In a randomized, single-blinded,
placebo-controlled, multi-center (16 sites led by MD Anderson
Cancer Center) Phase IIb clinical trial, no recurrences were
observed in the HER2/neu 3+ adjuvant setting after median 5 years
of follow-up, if the patient received the 6 primary intradermal
injections over the first 6 months (p = 0.0338). Of the 138
patients that have been treated with GLSI-100 to date over 4
clinical trials, treatment was well tolerated and no serious
adverse events were observed related to the immunotherapy.
Greenwich LifeSciences is planning to commence a Phase III clinical
trial using a similar treatment regime as the Phase IIb clinical
trial. 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.
About GP2 Immunotherapy Immune Response
As previously reported, GP2 immunotherapy generated GP2-specific
immune responses, leading to no metastatic breast cancer recurrence
in the HER2/neu 3+ population in the Phase IIb clinical trial, thus
supporting GP2’s mechanism of action. Statistically significant
peak immunity was reached after 6 months of GP2 treatment, as
measured in both the Dimer Binding Assay and the DTH skin test.
HER2/neu 3+ population immune response was similar to the HER2/neu
1-2+ population immune response, suggesting the potential to treat
the HER2/neu 1-2+ population (including triple negative breast
cancer) with GP2 immunotherapy in combination with trastuzumab
(Herceptin) based products and other clinically active agents. The
broad based immune response suggests the potential for GP2 to treat
other HER2/neu 1-3+ expressing cancers. For more information on GP2
immune response and clinical data, please visit the Company’s
clinical trial tab at
https://greenwichlifesciences.com/clinical-trials/.
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 titled “Risk Factors” in the final prospectus related
to the public offering filed with the SEC. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20211110005555/en/
Company Contact Snehal Patel Investor Relations (832)
819-3232 info@greenwichlifesciences.com
Investor & Public Relations Contact for Greenwich
LifeSciences Dave Gentry RedChip Companies Inc. Office:
1-800-RED CHIP (733 2447) Cell: (407) 491-4498 dave@redchip.com
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