Generex Biotechnology Announces
First Patient Enrolled in the Phase II Clinical Trial of AE37 in
Combination with Pembrolizumab (KeytrudaÒ) for the Treatment of
Triple Negative Breast Cancer
MIRAMAR, FL -- September 17, 2019 -- InvestorsHub NewsWire --
Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT)
(http://www.otcmarkets.com/stock/GNBT/quote)
today announced that the NSABP Foundation, Inc. (NSABP) has
enrolled the first patient in the study: A Phase II
Clinical Trial of Pembrolizumab in Combination with
the AE37 Peptide Vaccine in Patients with Metastatic Triple
Negative Breast Cancer (NSABP FB-14). The trial, conducted in
conjunction with research partners Merck and the NSABP Foundation,
is designed to evaluate the safety and tolerability of AE37 given
in combination with KEYTRUDAÒ (pembrolizumab) as well as the
objective response rate.
Eric von Hofe, President of NuGenerex-ImmunoOncology commented,
“This is an exciting milestone for NuGenerex Immuno-Oncology, as we
have now revitalized our AE37 development program with a focus on
combination therapy with checkpoint inhibitors, which are now
becoming standard of care for a broad array of cancers. Combining
our promising immunotherapeutic with Merck’s checkpoint inhibitor,
KEYTRUDA for the treatment of triple negative breast cancer
represents a novel treatment strategy for a cancer of high unmet
need. Prior studies with each agent alone showed promising signs of
efficacy. By combining the mechanisms of checkpoint inhibition by
KEYTRUDA with the robust, long-lasting and tumor-specific T-cell
activation by AE37, we hope to enhance the clinical effectiveness
of the immunotherapy strategies.”
Jason Terrell, MD, Chief Scientific and Medical Officer of
Generex Biotechnology commented, “The start of patient enrollment
represents the culmination of a committed effort by the team at
NuGenerex Immuno-Oncology (formerly Antigen Express) and our
research partners at the NSABP Foundation and Merck. NuGenerex
Immuno-Oncology has been a pioneer on the forefront of
immunotherapy for over a decade with our Ii-Key platform that
ensures CD4 T-cell activation against any tumor antigen to which
the Ii-Key is attached. The Ii-Key platform holds great promise,
and we plan to initiate additional trials using the combination of
checkpoint inhibitors with AE37 immune system activation in the
field of personalized immuno-oncology to help patients in need of
treatment options.”
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.
About Generex Biotechnology Corp.
Generex Biotechnology is an integrated healthcare holding company
with end-to-end solutions for patient centric care from rapid
diagnosis through delivery of personalized therapies. Generex is
building a new kind of healthcare company that extends beyond
traditional models providing support to physicians in an MSO
network, and ongoing relationships with patients to improve the
patient experience and access to optimal care.
In addition to advancing a legacy portfolio of immune-oncology
assets, medical devices, and diagnostics, the Company is focused on
an acquisition strategy of strategic businesses that complement
existing assets and provide immediate sources of revenue and
working capital. Recent acquisitions include a management services
organization, a network of pharmacies, clinical laboratory, and
medical device companies with new and approved products.
Our newly formed, wholly-owned subsidiary, NuGenerex
Distribution Solutions (NDS), integrates our MSO network with a
pharmacy network, clinical diagnostic lab, durable medical
equipment company (DME-IQ) and dedicated call center.
About Olaregen Therapeutix
Olaregen Therapeutix, Inc. is a regenerative medicine company
focused on the development, manufacturing and commercialization of
products that fill unmet needs in the current wound care market.
Generex aims to provide advanced healing solutions that
substantially improve medical outcomes while lowering the overall
cost of care. Olaregen's first product
introduction, Excellagen (flowable dermal
matrix) is a topically applied product for dermal wounds and other
indications. Excellagen is a FDA 510K cleared
device for a broad array of dermal wounds, including partial and
full thickness wounds, pressure ulcers, venous ulcers, diabetic
ulcers, chronic vascular ulcers, tunneled/undermined wounds,
surgical wounds (donor sites/ grafts, post-Mohs surgery, post-laser
surgery, podiatric, wound dehiscence), trauma wounds (abrasions,
lacerations, second-degree burns and skin tears) and draining
wounds, enabling Olaregen to
market Excellagen in multiple vertical markets.
Additionally, Excellagen can serve as an
Enabling Delivery Platform for pluripotent stem cells,
antimicrobial agents, small molecule drugs, DNA-Based Biologics,
conditioned cell media and peptides. Olaregen's initial focus will
be in advanced wound care including diabetic foot ulcers (DFU),
venous leg ulcers and pressure ulcers. Future products focusing on
innovative therapies in bone and joint regeneration comprise the
current pipeline. Generex's mission is to become a significant
force in regenerative medicine and advance the science of
healing.
About our Service-Disabled Veteran-Owned Small Business
(SDVOSB)
This a Service-Disabled Veteran-Owned Small Business (SDVOSB) that
specializes in the sale, marketing, and distribution of innovative
medical products through a nationwide network of veteran owned
distribution services.
About Pantheon Medical
Pantheon Medical is a manufacturer of a physician friendly,
“all-in-one”, integrated kit that includes plates, screws, and
tools required for orthopedic surgeons and podiatrists conducting
foot and ankle surgeries. Generex is developing and submitting
several new product lines to the FDA which will include cannulated
surgical screws, plates, and implants.
About MediSource Partners
MediSource Partners is a 10-year-old private company, currently
contracted with over 25 vendors (including Pantheon Medical) for
nationwide distribution of implants and devices for spine, hips,
knees, foot, ankle, hand, and wrist surgeries. Additional product
lines include biologics (blood, bone, tissue, stem cells), durable
medical equipment, and soft goods. Generex also supplies kits to
process bone marrow aspirates and platelet rich plasma biologics at
the time of surgery.
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
1-800-391-6755 Extension 222
investor@generex.com
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