Greenwich LifeSciences CEO Participates in TD Ameritrade Interview to Discuss 2021 SABCS Poster
December 15 2021 - 6:00AM
Business Wire
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 CEO Snehal Patel participated in a TD Ameritrade interview to
discuss the Phase IIb poster presented at the 2021 San Antonio
Breast Cancer Symposium on December 9, 2021.
Mr. Patel appeared for a second time as a featured guest in a
live interview on TD Ameritrade Network's The Watch List with host
Nicole Petallides. A webcast of the interview can be seen here.
In the interview, Mr. Patel discussed how the new Phase IIb
clinical trial findings could lead to a new treatment that
complements GP2 peptide therapy and allows doctors to detect
metastatic breast cancer recurrences earlier. The newly published
Phase IIb clinical trial data shows that 22.8% of 145 patients had
an immune response to GP2 prior to any treatment with GP2.
Typically, no response to GP2 would be expected until after
treatment with GP2. However, an immune response was seen in these
patients before any treatment with GP2, suggesting that their
cancer was already recurring. The data suggests that patients with
an immune response to GP2 prior to treatment recurred twice as fast
and approximately 7 to 11 months sooner than those without an
immune response prior to treatment did. The number of recurrences
was low in the Phase IIb clinical trial, so these observations will
be confirmed further in the larger Phase III trial, and the data
will be available as early as 2022.
Mr. Patel continued to discuss how in the Phase III clinical
trial, T cells will be fully characterized and identified at the
DNA level to better understand the initial immune response to GP2.
GP2 immunotherapy trains T cells to attack metastatic breast
cancer. By identifying the GP2 specific T cells that are attacking
the cancer, the most effective T cells could be developed as drug
candidates and given directly to patients as a treatment using
CAR-T cell technology. Thus the Company could use this new
patentable T cell technology for both diagnosis and treatment,
expanding the Company’s pipeline beyond just GP2 and further
benefiting patients.
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/20211214006424/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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