‒ The GP2 Phase III clinical trial design was presented during
the 2020 San Antonio Breast Cancer Symposium (SABCS) and introduced
by the Global Principal Investigator, Professor Mothaffar F. Rimawi
of Baylor College of Medicine
‒ In the Phase IIb clinical trial, led by MD Anderson, a
0% recurrence rate was observed in the
HER2/neu 3+ adjuvant setting after median 5 years of follow-up if
the patient received the 6 primary intradermal injections of GP2
immunotherapy over the first 6 months (p = 0.0338), and a robust
immune response, a well-tolerated safety profile, and no serious
adverse events were reported
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
publication of a second poster for the GP2 Phase III clinical trial
design for recurring breast cancer at the San Antonio Breast Cancer
Symposium (SABCS) in a virtual format. The Global Principal
Investigator of the GP2 Phase III clinical trial, Dr. Mothaffar F.
Rimawi of the Dan L Duncan Comprehensive Cancer Center at Baylor
College of Medicine, is the lead author of the poster and has
recorded an audio track providing an overview. The full poster with
audio can be accessed or downloaded here on the Company website, as
well as on the conference website by attendees.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20201211005203/en/
Poster OT-13-03: GP2 Phase III Clinical
Trial Design for Recurring Breast Cancer (Graphic: Business
Wire)
Poster OT-13-03 is entitled: A prospective, randomized,
multicenter, double-blinded, placebo-controlled Phase III trial of
the HER2/neu peptide GP2 + GM-CSF versus bacteriostatic saline/WFI
placebo as adjuvant therapy after any trastuzumab-based therapy in
HER2-positive women with operable breast cancer.
The Phase III 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 readout, after which a Biologics Licensing
Application will be submitted. The Phase III clinical trial aims to
reproduce the Phase IIb clinical trial that concluded that the
completion of the first 6 intradermal injections of GP2 + GM-CSF
safely elicited a potent immune response and reduced recurrence
rates to 0% in HER2/neu 3+ patients who received a standard course
of trastuzumab after surgery.
Snehal Patel, CEO of Greenwich LifeSciences, commented, “We are
preparing diligently for our pivotal Phase III clinical trial,
aligning ourselves with one of the leading cancer institutions in
the world. We appreciate the overwhelming response to our first
poster, where we reported the final efficacy results of our Phase
IIb clinical trial showing no breast cancer recurrences in HER2/neu
3+ patients if they were fully immunized with GP2. Our partnership
with Dr. Rimawi and Baylor College of Medicine gives us great
confidence in our objective to replicate this data in the Phase III
clinical trial.”
The Phase III clinical trial is a prospective, randomized,
double-blinded, multi-center study. After 1 year of
trastuzumab-based therapy or an approved biosimilar, treatment with
GP2 + GM-CSF or placebo will be administered intradermally for the
6 primary immunization series over the first 6 months and 5
subsequent boosters over the next 2.5 years for a total of 11
injections over 3 years of treatment. The participant duration of
the trial will be 3 years of treatment plus 2 years of follow-up
for a total of 5 years following the first year of treatment with
trastuzumab-based therapy or approved biosimilar. The majority of
the patient population will be HER2/neu positive, HLA 2+,
disease-free, conventionally treated node-positive, post- surgery,
and post- first year of treatment with trastuzumab. An interim
analysis is planned and patients will be stratified based on prior
and current treatments, among other factors.
About SABCS
The 43rd annual SABCS has grown to be the industry’s premier
breast cancer conference for basic, translational, and clinical
cancer research professionals. It is well-known for presenting the
latest breast cancer data from all over the world. More than 7,500
health care professionals from more than 90 countries attend
annually. Baylor College of Medicine became a joint sponsor of
SABCS in 2005. The Cancer Therapy & Research Center at UT
Health Science Center San Antonio and American Association for
Cancer Research began collaborations with SABCS in 2007. For more
information, please visit the conference website at:
https://www.sabcs.org/
Baylor College of Medicine
Baylor College of Medicine (www.bcm.edu) in Houston is
recognized as a health sciences university and is known for
excellence in education, research and patient care. It is the only
private medical school in the greater southwest and is ranked 22nd
among medical schools for research and 4th for primary care by U.S.
News & World Report. Baylor is listed 21st among all U.S.
medical schools for National Institutes of Health funding and No. 1
in Texas. The Baylor pediatrics program is ranked 6th among all
pediatric programs, reflecting the strong affiliation with Texas
Children’s Hospital where our faculty care for pediatric patients
and our students and residents train. Nationally, our physician
assistant program was ranked 3rd in the health disciplines category
and our nurse anesthesia program ranked 2nd. Located in the Texas
Medical Center, Baylor has affiliations with seven teaching
hospitals and jointly owns and operates Baylor St. Luke’s Medical
Center, part of CHI St. Luke’s Health. Currently, Baylor has more
than 3,000 trainees in medical, graduate, nurse anesthesia,
physician assistant, orthotics and genetic counseling as well as
residents and postdoctoral fellows. Follow Baylor College of
Medicine on Facebook
(http://www.facebook.com/BaylorCollegeOfMedicine) and Twitter
(http://twitter.com/BCMHouston).
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201211005203/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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