With Type 2 Diab news GNBT couda shuda wooda:
Folks in GNBT better know Antigen site exists
antigenexpress.com
antigenexpress.com
and
Antigen Express is a platform and product-based company developing proprietary vaccine formulations for large, unmet medical needs. Our focus is on stimulating critical members of the immune response, known as T helper cells.
The technology allows for antigen-specific stimulation or suppression of a T-helper response to virtually any antigen of known pathogenic potential. Consequential, Antigen Express is building a deep pipeline of therapeutics aimed at a variety of major diseases, including cancer, infectious diseases and autoimmune-based syndromes.
Antigen Express therapies are based on highly selective modulation of the immune response, in contrast to most current immunomodulation strategies that are in general non-specific. This lack of specificity is the prime source for unwanted side effects. The therapies developed at Antigen Express intervene at the critical stage of antigen presentation to modulate the immune response. This targeted approach results in a potent up or down regulation of critical members of the immune system.
The technologies developed at Antigen Express are novel and highly complementary to existing approaches of immune modification. Therefore, the company is uniquely positioned to develop partnerships where Antigen Express technology enhances or augments the corporate partners’ technology or product portfolios.
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8/16/2005 PANDEMIC INFLUENZA VACCINE DEVELOPMENT ACCELERATED AT GENEREX BIOTECHNOLOGY WITH HIRE OF ACCOMPLISHED SENIOR SCIENTIST
Novel vaccine technology boosts T helper cell responses to Asian bird flu influenza, to aid some existing vaccines and for use as a stand-alone vaccine
in developing countries
TORONTO, Canada – August 16, 2005 – Generex Biotechnology Corporation (NasdaqSC: GNBT) announced today that Antigen Express, Inc., its wholly owned immunotherapeutics subsidiary, hired Dr. John Zinckgraf, Ph.D. to accelerate development of a novel vaccine for pandemic influenza.
Dr. Zinckgraf received his Ph.D. in Molecular and Cellular Biology from the University of Connecticut where his primary research focus was DNA vaccine development and delivery. He tested novel DNA vaccines for HIV and HBV, using various inducible and constitutive promoters as well as different polyadenlylation sequences. Such genetic elements can regulate antigen synthesis and consequently the magnitude of the immune response to a vaccine. Following his doctoral work, Dr. Zinckgraf was as a postdoctoral fellow at Epimmune, Inc. in San Diego, California where he pursued pre-clinical development of several infectious disease vaccines, using the company’s DNA vaccine minigene technology. Dr. Zinckgraf returned to the University of Connecticut as a postdoctoral scientist to develop vaccine delivery systems for foot-and-mouth disease virus, as well as development and expression of single-chain antibodies against chemical and tobacco carcinogens.
Dr. Zinckgraf was recruited to Antigen Express in view of his extensive experience and strong track record in advancing vaccine technologies. Dr. Robert Humphreys, Chief Scientific Officer of Antigen Express, Inc., said, “John is an excellent scientist who was recommended with highest enthusiasm by his mentors as a creative and hard working immunologist. In a few short months, he has greatly advanced the pace of our programs in influenza and is a superb strategic planner and experimentalist.”
Dr. Zinckgraf said, “I am pleased to join the Antigen Express group of scientists. The technology is novel and recognized by senior academic and corporate scientists. We are making rapid progress toward testing a series of Ii-Key/T-helper cell epitope vaccines specific to protect against the pandemic form of Asian bird flu.”
Dr. Zinckgraf explained further that his colleagues at Antigen Express have discovered that a segment of the Ii immunoregulatory protein acts on the antigenic peptide presenting molecules in a manner that boosts the presentation of T-helper cell epitopes to the immune system. Using such a vaccine in humans could augment the response to subsequent vaccination by a flu virus vaccine or as a stand-alone vaccine to prevent viral infection.
The Antigen Express team is developing a vaccine for pandemic Asian bird flu (H5N1 strain) based on H5 MHC class II epitopes, which have been selected for likelihood of being both potent and presented by many HLA-DR alleles. Ii-Key/MHC class II epitope hybrid peptides contain an immunoregulatory segment of the Ii protein (the Ii-Key moiety), loosening the epitope-binding groove of MHC class II molecules and permitting insertion of a polymethylene-linked MHC class II epitope. Doing so increases the potency of epitope presentation 200 times in vitro, as measured in a T-cell hybridoma response assay. In addition, Ii-Key hybrids with principal MHC class II epitopes of various cancer and infectious disease antigens increase the T-helper cell response 4-8 times in vaccinated mice, as measured using purified CD4+ T cell IFN-? ELISPOT assays. Presently, Antigen Express has an ongoing phase I clinical trial with Her-2/neu breast cancer hybrids. Data from these trials are relevant to establishing the safety and effect of this novel type of vaccine, for later use in validating an influenza vaccine.
Anna Gluskin, CEO of Generex Biotechnology said, “I am very pleased with the rapid advance of this vaccine program. Our earlier work on developing a vaccine for the SARS virus put us into a forward position with design concepts and animal models for infectious disease. Now we are shifting focus toward the Asian bird flu vaccine because that threat is potentially so gigantic. We feel that this T-helper cell peptide vaccine might be all that is available, in a rapid time frame, for people in many parts of the world. It is also an excellent priming vaccine, to be used before or with other vaccines which are being developed.”
About Generex
Generex is engaged in the research and development of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company’s proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company’s proprietary RapidMist™ device. The Company’s flagship product, oral insulin (Oral-lyn™), which has been approved for commercial sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes, is in various stages of clinical trials around the world. Antigen Express is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutics for the treatment of malignant, infectious, allergic, and autoimmune diseases.
For more information, visit the Generex Web site at www.generex.com.
Safe Harbor Statement: This release and oral statements made from time to time by Generex representatives concerning 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," "plans," "intends," "believes," "will," "estimates," “forecasts," "projects" 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 claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.
Shayne Gilliatt of Generex Biotechnology Corporation, 1-800-391-6755, or +1-416-364-2551; or Ken Sgro of CEOcast, Inc., 212-732-4300, kensgro@ceocast.com, for Generex Biotechnology Corporation
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