Greenwich LifeSciences Hires Industry Expert, Dr. Jaye Thompson, to Manage Phase III Clinical Trial for Recurring Breast Cancer
March 08 2021 - 5:00AM
Business Wire
- Actively involved in over 200 clinical trials
- 30 years experience in managing clinical trials and FDA
interactions, leveraging biostatistics PhD
- Founding partner of multiple CROs
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
hiring of Jaye Thompson, PhD as Vice President Clinical and
Regulatory Affairs to oversee the upcoming GP2 Phase III clinical
trial on a full time basis.
Dr. Thompson commented, “I am excited to begin managing our
Phase III clinical trial for recurring breast cancer. Our drug is
addressing a critical unmet need. Over 3 million U.S. breast cancer
survivors need safe and effective drugs to prevent metastatic
breast cancer recurrence. The fact that our GP2 Phase IIb clinical
data showed no breast cancer recurrences over 5 years gives me
confidence that GP2 has the potential to save hundreds of thousands
of lives and to return affected women back to normal and healthy
lives. I look forward to leveraging my prior experiences in
protocol and trial design, clinical trial start-up activities,
clinical trial management, statistical analysis of clinical and
biomarker data, and management of relationships with U.S. and
European regulators as we commence the GP2 Phase III trial. I am
also committed to exploring all viable regulatory pathways to make
GP2 available to clinicians and patients as soon as possible.”
Snehal Patel, CEO of Greenwich LifeSciences, commented, “We are
very fortunate that Dr. Thompson is joining the Company on a full
time basis. While she has been invaluable in advising the Company
in the past, her expanded role and responsibilities will allow the
Company to start enrolling patients in the planned Phase III
clinical at multiple sites, giving us an even stronger start as we
seek to reproduce our promising Phase IIb clinical trial results.
Dr. Thompson will be responsible for overseeing the GP2 Phase III
clinical trial as we finalize the protocol, engage outside CRO
support, recruit sites, and coordinate with the Baylor College of
Medicine, our lead site. Under her leadership, we have already
engaged a CRO and statistician to assist us in start-up activities.
In addition, her vast experience will help us to optimize the
utilization of our cash resources as we allocate them towards
completing the interim analysis and data read out of the Phase III
trial and towards a potential filing of a BLA for conditional
marketing approval of GP2.”
Dr. Thompson has over 30 years of experience in pharmaceutical
and device product development. She was a co-founder and Chief
Operating Officer of Proxima Clinical Research, a founder and
former President of Synergos, and leader at inVentiv Clinical
Solutions, which are clinical research service providers. In these
positions, Dr. Thompson supported clinical stage companies in
strategic clinical and regulatory planning, as well as in the
execution of those plans. Dr. Thompson previously led the clinical
and regulatory affairs efforts at Repros Therapeutics and Opexa
Therapeutics. She has directed and managed statistical analysis,
data management, report writing, and the conduct of clinical trials
for a wide variety of indications. Dr. Thompson has been actively
involved in over 200 clinical trials for drugs, biologics, and
devices, and she has been associated with numerous FDA regulatory
submissions and has represented sponsor companies at FDA meetings
and advisory committee meetings. Dr. Thompson was appointed to the
Governor’s Texas Emerging Technology Fund Advisory Committee. She
received a BS in Applied Mathematics from Texas A&M University
and an MS and a PhD in Biostatistics from the University of Texas
Health Science Center in Houston.
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 at www.greenwichlifesciences.com and follow the
Company's Twitter at https://twitter.com/GreenwichLS.
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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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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