Greenwich LifeSciences Announces New Manufacturing Agreement for its Planned Phase III Clinical Trial & Enters into Lease for...
December 03 2020 - 7:00AM
Business Wire
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 it has entered into a contract for the final formulation and
filling of GP2 into vials, which when completed will allow for the
storage and distribution of GP2 to clinical sites. The contract
manufacturer plans to commence activities in 2021. In addition, the
Company has leased office, laboratory, and storage space to provide
research, manufacturing, and clinical trial support activities.
Snehal Patel, CEO of Greenwich LifeSciences, commented, “We are
pleased to have entered into these key manufacturing and facility
agreements, which along with the continued recruitment of key
opinion leaders and clinical sites, will be some of the major last
steps before commencing the upcoming Phase III clinical trial.”
The Company’s new manufacturing partner specializes in the
current Good Manufacturing Practice (cGMP) of formulating, filling,
and labeling drug vials and follows the recent completion of the
manufacturing of the GP2 active ingredient.
The Company’s new facility is located in Stafford, Texas and
will enable the Company to support its manufacturing activities,
develop analytical methods, and process clinical trial samples. The
facility may also be instrumental in supporting potential
additional research and development activities into other drug
products that could complement the GP2 immunotherapy platform and
expand the pipeline of the Company.
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. 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 Securities and Exchange Commission. 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/20201203005349/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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