Generex Biotechnology Signs Letter
of Intent to Acquire 51% in ALTuCELL, Inc. and their Cellular
Therapy Product Altsulin® with Patented Microencapsulation
Technology for the Treatment of Type I Diabetes Mellitis
- Patented cell encapsulation technology enables cell
implantation for therapeutic and regenerative medicine application
without immune system rejection
- Microcapsules formulated with ultra-purified alginates and
poly-L-ornithine previously have previously received authorization
from the EMEA and Italian Medicines Agency for for use in patients
with type 1 diabetes (T1D)
- 4 transplanted human patients with long-standing T1D have shown
evidence of grafted encapsulated islet cell function throughout 5
years of post-transplant follow-up
- Altsulin® (Microencapsulated Sertoli Cells) currently in human
proof-of-concept clinical study in patients with Laron
syndrome
- Clinical development of Altsulin for the treatment of T1D
MIRAMAR, FL -- September 9, 2019 -- InvestorsHub NewsWire --
Generex Biotechnology Corporation (GNBT)
is pleased to announce that the Company has signed a binding letter
of intent (LOI) to partner with ALTuCELL, a privately held
biotechnology company in a stock and cash transaction. ALTuCELL,
Inc. is a cellular engineering and biotech company backed by sound
research and science focused on fulfilling a large "unmet need" in
cell, molecular and regenerative therapy for treatment of diabetes
and other autoimmune and neurodegenerative diseases. The company’s
proprietary and unique technology overcomes the major barriers to
transplantation by a novel strategy utilizing patented
microencapsulation technology, enabling a transplantable,
cell-based therapy that avoids detection and rejection by the
immune system.
ALTuCELL is presently engaged in a human proof of concept study
designed to evaluate the ability of Altsulin to increase serum
levels of Insulin-Like Growth Factor-1 (IGF1) in patients with
Laron Syndrome (aka Laron-type dwarfism), an autosomal recessive
disorder characterized by an insensitivity to growth hormone (GH),
usually caused by a mutant growth hormone receptor. Patients with
Laron Syndrome, a pediatric orphan disease, have the lowest level
IGF1 values seen in any disease. Altsulin has demonstrated
significant effectiveness in increasing serum levels IGF1 in all
pre-clinical animal models tested to date, providing the
pharmacologic basis for the implanted Sertoli Cell therapy. For
additional information please visit the ALTuCELL web site
(https://altucell.com/home).
In animal models, ALTuCELL’s microencapsulated cell technology
have been proven safe and effective not only in the treatment of
T1D, but also of other chronic diseases, including
neurodegenerative diseases such as Huntington’s disease and lethal
neuromuscular disorders like Muscular Dystrophy. As for the
latter, pre-clinical data look very strong toward clinical
application.
The ALTuCELL microencapsulation technology has also demonstrated
effective implantation of numerous cell types including Mesenchymal
Stem Cells extracted from the post-partum human umbilical cord
(Wharton’s Jelly) for the treatment of early onset type 1 diabetes
and other regenerative medicine applications.
Joe Moscato, President & Chief Executive Officer of Generex
stated, “We can’t be more excited about this partnership with
ALTuCELL and their CEO Gary Harlem to join forces in our common
goal to conquer diabetes. With this acquisition, we are reigniting
our diabetes-focused development efforts, gaining a clinical-stage
cellular therapeutic product, Altsulin for the potential cure of
Type I diabetes, as well as the best-in-class, globally patented
cellular microencapsulation technology that enables rapid,
patent-protected pipeline expansion of cellular and regenerative
therapy products. We are building NuGenerex Health MSO with a team
of endocrinologists and primary care physicians to provide
integrated specialty healthcare services for patients with
diabetes. Plus, we are now positioned to bring back the Oral-Lyn
program with the clinical development of our reformulated Oral-Lyn
II that is designed to require only two sprays for glycemic
control. Generex will once again be a force in diabetes, and we are
happy to have ALTuCELL as an integral part of our plans.”
Gary Harlem, ALTuCELL’s President & Chief Executive Officer
commented, “I have made it my life’s mission to find a cure for
Type I Diabetes, and have been working for nearly a decade with Dr.
Riccardo Calafiore, Dr. Giovanni Luca and Dr. Giuseppe Basta from
the University of Perugia Department of Medicine to perfect the
technology for cellular implantation. Our patented process ensures
that our microcapsules are pure and virtually endotoxin free and
maintain their immunoisolatory properties in vivo, with no
toxicities nor immune rejection. We are excited to begin U.S.
trials over the next few months, working closely with our expert
scientific team and founders.
Mr. Harlem continued, “We are extremely happy to join Generex and
to work with their highly experienced management team to bring
Altsulin through clinical development to the market. It is great to
have a diabetes expert like Dr. James 'Andy' Anderson on the
Generex team for guidance on our development program. Additionally,
the NuGenerex MSO model provides a number of benefits to us,
including access to physician researchers and a large population of
patients with diabetes who will be eligible for clinical trials.
With the Generex end-to-end model, these doctors and patients are
not only research partners but also future customers. We are
excited for the future.”
Generex will provide additional details on the deal as the
transaction is finalized.
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 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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