Greenwich LifeSciences Expands Role of Industry Expert Dr. F. Joseph Daugherty to Include Medical Monitor for its Upcoming Phase III Clinical Trial
December 07 2021 - 6:34AM
Business Wire
- Dr. Daugherty has 40+ years of experience managing
biotechnology projects and companies focused on cancer, immunology,
vaccines, and nutraceuticals
- Dr. Daugherty will serve as medical monitor for the upcoming
Phase III clinical trial and for potential future clinical trials,
focusing on assessing any safety issues that arise on a real-time
basis, leveraging his MD from the University of Nebraska Medical
Center and prior experience as a medical monitor for
oncology-related clinical trials.
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 the
expansion of Dr. F. Joseph Daugherty’s role to include the critical
responsibility of Medical Monitor of the Phase III clinical trial
and a long-term agreement to serve as Chief Medical Officer.
Dr. Daugherty commented, “I look forward to supporting the
GLSI-100 clinical trials as Medical Monitor. While GP2 has been
shown to be both effective and safe in the Phase IIb trial, we will
maintain our vigilance in the larger Phase III trial. The mild
local and systemic reactions observed in the Phase IIb trial have
served to further validate the immune response and mechanism of
action of GP2, thus requiring the balancing of dosing to ensure
that local and systemic reactions are tolerable and safe, yet still
sufficiently robust enough to lead to the prevention of metastatic
breast cancer recurrence.”
CEO Snehal Patel added, “We are very excited that Dr. Daugherty
is expanding his role with a very significant commitment to serve
as medical monitor of our upcoming and future clinical trials as we
seek to expand GP2’s potential to all HER2 positive breast cancer
patients and to explore HER2 low breast cancer and other HER2
expressing cancers. While we have not seen any serious adverse
events in the 138 patients we have treated to date across four
clinical trials attributable to GP2 immunotherapy, Dr. Daugherty’s
responsibility to oversee the safety of our Phase III trial will be
a key component of our regulatory strategy in this potential single
registration trial.”
Dr. Daugherty has over 40 years of experience in managing and
overseeing biotechnology and biomedical projects. He served first
as President and recently as Chief Executive Officer, Chief Medical
Officer, and the Chairman of the board of directors of Eleos, Inc.,
a clinical-stage, private biotech company focused on anti-sense
technology in hematologic cancers. In addition to being an officer
and director, Dr. Daugherty has served in various other capacities,
including as a management consultant to over 20 public and private
biomedical companies including Dupont, Inc, and as President of
ConAgra’s biotech division. He received a BA in Biology from
Washington University, a MD from the University of Nebraska, and a
MS in Industrial Administration from Carnegie Mellon
University.
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/20211207005600/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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