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 announced
that the Company will participate in the following interviews and
conferences.
Today at 5:00 pm, the Company’s management team will be
presenting two posters at the 2021 San Antonio Breast Cancer
Symposium (SABCS) in person. The Company anticipates making the
SABCS Phase IIb poster available on its website by the morning of
December 9, exactly one year after the 2020 SABCS poster was
published showing that no metastatic breast cancer recurrences were
observed over 5 years of follow-up in HER2 positive patients who
were fully treated. On December 9 at 2:20 pm ET, Snehal Patel, CEO
of Greenwich LifeSciences, will appear as a featured guest in a
live interview on TD Ameritrade Network's The Watch List with host
Nicole Petallides to discuss the poster.
A second poster at SABCS will provide further design features of
the Phase III clinical trial for discussion with attending
clinicians. At this hybrid conference the Company will be meeting
with clinicians participating in the Phase III trial and with
members of the Data Safety Monitoring Board and the Clinical
Advisory/Steering Committee, both of which will provide independent
oversight of the Phase III trial and will advise the Company on the
conduct of the trial. The Company also hosted a dinner to bring the
Phase III clinical team together.
An exclusive interview with CEO Snehal Patel was aired a second
time on The RedChip Money Report® on Bloomberg TV this past
Saturday, December 4. In the interview Mr. Patel discusses the
Phase IIb clinical trial results, the next steps for the upcoming
FLAMINGO-01 Phase III clinical trial, potential Phase IIb and Phase
III clinical data publications in 2022, the impact of joining the
Russell 2000, and examples of recent comparable strategic
transactions in breast cancer and immunotherapy. To view a replay
of the interview, please click here.
During the week of January 10, 2022, Mr. Patel will participate
in the following three virtual/hybrid investor conferences:
H.C. Wainwright 2022 BioConnect Conference:
The Company will be participating in the H.C. Wainwright
BioConnect Conference with a virtual presentation that will be
available on demand.
Biotech Showcase 2022:
The Company will be participating in the Biotech Showcase
partnering event with an on-demand presentation available to
conference participants and potentially an in-person presentation
should conditions permit.
BIO Partnering at JPM:
The Company will be participating in the BIO partnering event at
the 2022 JP Morgan Healthcare Conference.
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/20211208005036/en/
Company Contact Snehal Patel Investor Relations Office:
(832) 819-3232 Email: 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 Email:
dave@redchip.com
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