GNBT - Generex Announces Clinical Trial for Breast Cancer Treatment Conducted in Conjunction with Merck
28 November 2018 - 1:27AM
InvestorsHub NewsWire
Generex
Biotechnology Signs Clinical Trial Agreement with the NSABP
Foundation, Inc. for Phase II Clinical Trial of AE37 in
Combination with Pembrolizumab
(KeytrudaÒ)
for Treatment of Triple-Negative Breast
Cancer
NSABP to Provide Clinical Trial
and Site Management Services for
Antigen Express and Research
Partner Merck on AE37/KeytrudaÒ Combination Trial
Miramar,
FL -- November 27, 2018 -- InvestorsHub NewsWire --
Generex Biotechnology Corporation (OTCMKTS:GNBT)
has signed a clinical trial agreement (CTA) with the NSABP
Foundation, Inc. (NSABP), to manage a Phase II clinical
trial of Pembrolizumab (KeytrudaÒ) in combination with the
AE37 Peptide Vaccine in Patients with Metastatic Triple Negative
Breast Cancer.
The
clinical trial, sponsored by Generex and conducted in conjunction
with Merck (NYSE:
MRK), is currently being reviewed by the FDA, and clinical
operations including site qualification, drug shipment and
packaging, and IRB review and approval are underway, with plans to
enroll patients in the first quarter of
2019.
Eric von
Hofe, President of Generex’s wholly-owned subsidiary Antigen
Express, commented, “We are very pleased to be working with the
NSABP Foundation on this important trial combining AE37 and
KeytrudaÒ
in triple-negative breast cancer patients. The extensive
expertise of the NSABP Foundation and their network of sites and
investigators will be a great asset in this development
effort.”
Generex
EVP of R&D Richard Purcell commented, “This contract with our
research partners at the NSABP Foundation provides cost and
timeline certainty to our AE37 development program in combination
with KeytrudaÒ. We look forward to our
continued collaboration with Merck and the NSABP Foundation
research team.”
Previously, the Company reported that it filed an
investigational new drug application (IND) with the U.S. Food &
Drug Administration (FDA) to initiate A Phase II Clinical
Trial of Pembrolizumab (Keytruda®) in Combination with the AE37
Peptide Vaccine in Patients with Metastatic Triple Negative Breast
Cancer.
About AE37
AE37 is an
investigational therapeutic cancer vaccine being developed to treat
cancer in women with certain types of breast cancer. It is a
combination of portions of two proteins that together stimulate the
immune system to fight cancer cells.
Up to 80
percent of breast cancers express some level of a protein called
HER2. While treatments exist to target HER2 in breast cancer
patients with the highest level of HER2 expression (roughly 25%),
the majority of patients who have lower levels of expression have
more limited treatment options. AE37 consists of a protein derived
from the HER2 protein combined with a portion of the MHC class II
associated invariant chain which has been termed
Ii-Key.
AE37 does
not directly target HER2, but instead acts as a vaccine to activate
the immune system to recognize the HER2 protein that is expressed
on cancer cells as foreign.
AE37
ensures activation of CD4-positive lymphocytes, immune cells that
are important in stimulating both the antibody response (antibodies
against HER2) and cellular responses directed against the HER2
protein in breast cancer cells. The Ii-Key peptide is coupled with
the HER2 protein to ensure a more robust and long-lasting
response.
About the NSABP
Foundation, Inc.
The NSABP
Foundation is a non-profit organization devoted to improving the
survival outcome and quality of life of patients with breast or
colorectal cancer. The Foundation has a long history of developing
new treatments that have improved the standard of care for cancer
patients worldwide both through NCI-sponsored studies and in
collaboration with industry.
Cautionary Note Regarding Forward-Looking
Statements
This
release and oral statements made from time to time by Generex
representatives in respect of the same subject matter may contain
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements can be
identified by introductory words such as "expects," "plan,"
"believes," "will," "achieve," "anticipate," "would," "should,"
"subject to" or words of similar meaning, and by the fact that they
do not relate strictly to historical or current facts.
Forward-looking statements frequently are used in discussing
potential product applications, potential collaborations, product
development activities, clinical studies, regulatory submissions
and approvals, and similar operating matters. Many factors may
cause actual results to differ from forward-looking statements,
including inaccurate assumptions and a broad variety of risks and
uncertainties, some of which are known and others of which are not.
Known risks and uncertainties include those identified from time to
time in the reports filed by Generex with the Securities and
Exchange Commission, which should be considered together with any
forward-looking statement. No forward-looking statement is a
guarantee of future results or events, and one should avoid placing
undue reliance on such statements. Generex undertakes no obligation
to update publicly any forward-looking statements, whether as a
result of new information, future events or otherwise.
Generex claims the protection of the safe harbor for
forward-looking statements that is contained in the Private
Securities Litigation Reform Act.
Generex Contact:
Generex
Biotechnology Corporation
Joseph
Moscato
646-599-6222
Todd
Falls
800-391-6755 Extension 222
investor@generex.com
Russo Partners
Investor /
Media Contacts:
Alex
Fudukidis
(646)
942-5632
alex.fudukidis@russopartnersllc.com
Caroline
Cunningham
(212)
845-4292
Caroline.Cunningham@russopartnersllc.com
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