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 announced
that two abstracts have been accepted for presentation at the
upcoming American Association for Cancer Research (AACR) Annual
Meeting 2021, including two corresponding posters. The AACR 2021
conference will be held in a virtual format from April 10-15, 2021.
The AACR plans to publish the titles on March 10, 2021 at 4:30 pm
EST, the abstracts on April 9, 2021 at 12:01 am EST, and the
posters on April 10, 2021.
Snehal Patel, CEO of Greenwich LifeSciences, commented, “We are
pleased that both of our abstracts were accepted by the AACR. On
December 9, 2020, we presented the Phase IIb clinical trial Kaplan
Meier analysis of disease free survival for HER2/neu 3+ patients
treated with GP2 immunotherapy, which showed 100% survival over 5
years of follow-up (0% breast cancer recurrences, p = 0.0338) if
the patients received their primary GP2 treatments following
surgery and Herceptin treatment. In the first abstract and poster,
we are excited to present the final 5 year analysis of the
immune response over time for all
patients in the Phase IIb clinical trial.”
Patel added, “As the immune response is the primary mechanism of
action, this final analysis assessing GP2’s effectiveness in
creating peak immunity is important in further validating the
clinical outcome, where we observed the 0% recurrence rate, and
will provide more insight into the design of the Phase III clinical
trial, which is our second abstract and poster. Immune response
data is critical in developing dosing and booster treatment
strategies designed to achieve and sustain peak immunity, providing
protection against metastatic breast cancer recurrence for as long
as possible.”
The first abstract and poster will present the final 5 year
immune response data across all patient populations from the
completed prospective, randomized, placebo-controlled,
single-blinded, multicenter, Phase IIb clinical trial. The
presentation will include analysis of the various methods used to
measure immune responses for both HER2/neu 3+ and HER2/neu 1-2+
patient populations, including comparison of peak immune response
versus baseline immune response at multiple time points.
The second abstract and poster, jointly sponsored with Baylor
College of Medicine, will present the design of the planned Phase
III clinical trial. The clinical trial is designed as a single
registration trial that will include an interim analysis seeking
conditional marketing approval from the FDA upon the interim
analysis data read out followed by the submission of a Biologics
Licensing Application (BLA). Additional features of the clinical
trial design will be presented to breast cancer key opinion leaders
as we recruit clinicians and clinical sites for participation in
the Phase III clinical trial.
About the AACR Annual Meeting 2021
The AACR is the first and largest cancer research organization
dedicated to accelerating the conquest of cancer and has more than
48,000 members residing in 127 countries and territories. The AACR
Annual Meeting program covers the latest discoveries across the
spectrum of cancer research — from population science and
prevention; to cancer biology, translational, and clinical studies;
to survivorship and advocacy — and highlights the work of the best
minds in research and medicine from institutions all over the
world.
About Breast Cancer and HER2/neu Positivity
One in eight U.S. women will develop invasive breast cancer over
her lifetime, with approximately 266,000 new breast cancer patients
and 3.1 million breast cancer survivors in 2018. 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 GP2 to date over 4 clinical
trials, GP2 treatment was well tolerated and no serious adverse
events were observed related to GP2 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: www.greenwichlifesciences.com
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/20210225005368/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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