Generex Biotechnology Announces First-in-Human Clinical Trial
of the ALTuCELL Cellular Therapy Product Altsulin®
(Microencapsulated Sertoli Cells)
- Principal investigator Dr. Jaime Guevara Aguirre,
world-renowned expert on growth hormone to conduct the trial of
Altsulin® (Microencapsulated Sertoli Cells) in
Laron Syndrome Patients
- Laron Syndrome (aka Laron-type dwarfism) is a rare pediatric
orphan disease eligible for the FDA “Golden Ticket”
- Phase IIa proof-of-concept trial paves the way to commercial
development of Sertoli Cells for the treatment of Type I
Diabetes
MIRAMAR, FL -- November 05, 2019 -- InvestorsHub NewsWire
-- Generex Biotechnology Corporation (GNBT) is pleased to announce that the Company’s
soon to be subsidiary ALTuCELL, in collaboration with Dr. Jaime
Guevara-Aguirre, has submitted the proof-of-concept Phase IIa
clinical trial protocol to evaluate the safety of
Altsulin® (Microencapsulated Sertoli Cells) in
Laron Syndrome Patients to the Ecuadorian Ministry of Public Health
and the Institutional Review Board (IRB) at the Institute of
Endocrinology, Metabolism, and Reproduction (IEMYR). The
proof-of-concept clinical study is designed to demonstrate the
long-term safety of Sertoli cell implantation using ALTuCELL’s
encapsulation technology, the in vivo expression of Insulin-Like
Growth Factor-1 (IGF-1) from implanted Sertoli cells, and the
retrievability of Altsulin microcapsules using a proprietary
surgical technique.
As the Founder and Medical Director of IEMYR since 1987, Dr.
Guevara-Aguirre is widely recognized as a global leader in the
field of growth hormone and metabolic disorders, having published
multiple peer-reviewed publications concerning gonadotropin
membrane receptors, growth hormone receptor deficiency, alternative
routes of insulin administration, and hormonal determinants of
diabetes, cancer and dyslipidemias in humans with specific
mutations.
In addition to his duties as Medical Director at IEMYR, Dr.
Guevara-Aguirre has been an instructor of endocrinology in the
Department of Internal Medicine at the Central University in Quito,
a scientific advisor to the Vice President and the Minister of
Health of Ecuador, and a consultant to UNICEF. From 2007 to the
present, he has been professor in the Department of Pediatrics at
the University of Florida College of Medicine. Dr. Guevara-Aguirre
is the recipient of the National Award for Research of the
Ecuadorian Academy of Medicine in 1998, the Novartis Award for best
Ecuadorian medical scientist in 1998, and the Vicente Rocafuerte
Medal for Scientific Merit awarded by the National Congress of
Ecuador in 2007. In 1990, he worked with researchers at Stanford
University and the University of Florida to identify and publish
the genetic mutation that causes Laron dwarfism (NEJM Vol. 323 No.
20) in an isolated population in Ecuador, where we will conduct the
clinical trial. These patients have no Insulin-like Growth Factor
(IGF), so therefore they represent an excellent population in which
to study the ability of implanted Sertoli cells to produce
clinically meaningful levels of IGF-1. Coincidently, Dr.
Guevara-Aguirre previously served as a scientific advisor for
Generex, providing clinical guidance on the development of Oral-Lyn
buccal insulin spray for the treatment of Type I
diabetes.
“I am very happy to conduct this exciting trial of
microencapsulated Sertoli cells in our Laron patient population,”
said Dr. Guevara-Aguirre. “With this study, we hope to demonstrate
the many interesting properties of implanted Sertoli cells, which
can produce growth factors and peptide hormones like IGF-1 for our
patients with genetic deficiencies. In addition to protein
expression, these cells have demonstrated an ability in animal
models to rebalance the immune system to overcome autoimmune
disorders, including Type I diabetes and osteoporosis. It is a
pleasure to work with ALTuCELL and their research partners at the
University of Perugia to advance the cell therapy field and to
evaluate the clinical potential of Sertoli cells.”
Richard Purcell, Executive Vice President of Research &
Development at Generex stated, “We are looking forward to closing
our transaction with ALTuCELL as soon as we file our annual report
in the coming days. It is great working with ALTuCELL’s CEO Gary
Harlem and his outstanding team of scientists and clinicians who
are conducting cutting-edge research on microencapsulation and cell
implantation. This first-in-human trial of Altsulin in
collaboration with a key opinion leader like Dr. Guevara-Aguirre
provides us with numerous benefits that will enhance the commercial
development of ALTuCELL’s extensive patent portfolio that includes
microencapsulation of Sertoli Cells and stem cells for the
treatment of autoimmune and inflammatory diseases. The Laron trial
will provide a rapid and economic path to data on the safety and
therapeutic effect of Sertoli Cell implantation over 6 months, and,
perhaps as important, will demonstrate the retrievability of
implanted, encapsulated cells, as suggested by FDA. The potential
of Sertoli cells to overcome autoimmunity in Type I diabetes is
remarkable, and we are excited to initiate the trial with Dr.
Guevara-Aguirre and to begin the U.S. clinical development
program.”
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.
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
Generex Biotechnology (CE) (USOTC:GNBT)
Historical Stock Chart
From Mar 2024 to Apr 2024
Generex Biotechnology (CE) (USOTC:GNBT)
Historical Stock Chart
From Apr 2023 to Apr 2024