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Generex Biotechnology Announces First-in-Human Clinical Trial of the ALTuCELL Cellular Therapy Product Altsulin® (Microencapsulated Sertoli Cells)

925 Days ago

  • 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, Fla., Nov. 05, 2019 (GLOBE NEWSWIRE) -- /PRNewswire/ -- Generex Biotechnology Corporation (OTCQB: 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

Todd Falls
800-391-6755 Extension 222


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