Paper on Novel Cancer Vaccine from Generex Biotechnology is Published in Prestigous Journal of Immunotherapy
TORONTO, Aug. 23 /PRNewswire-FirstCall/ -- Generex Biotechnology Corporation (NASDAQ:GNBT) announced today the publication of a milestone paper in the prestigious cancer research journal Journal of Immunotherapy. This paper reports a late preclinical step in validating a novel melanoma vaccine for clinical trials. Parallel peptides containing MHC class II epitopes of the HER-2/neu antigen are in trials with patients with breast cancer.
Nikoletta Kallinteris is the leading scientist and first author of this paper entitled: "Insertion of melanoma gp100(48-56) epitope into the Ii-Key/MHC class II epitope hybrid peptide enhances CD4+ T cell responses in HLA-DR*0401 transgenic mice." This paper reports her work of the past two years on a novel concept in melanoma vaccination. The model uses a special type of mouse in which human antigenic epitope presenting molecules have been introduced genetically, with suppression of the comparable mouse molecules. By these means, the mice more closely model the human immunological situation.
Lea Kallinteris explained that cancer clinicians in many academic cancer centers have shown that peptide vaccines offer significant hope for immunotherapies in patients with established and potentially recurrent cancers. Melanoma is one of the most advanced models for identification and use of such peptide vaccines.
She further explained that many vaccine peptides have been developed for stimulation of patients' cytotoxic T lymphocytes to kill cancer cells. However, clinical trials with such vaccine peptides do not demonstrate particularly robust results. The reason for this lack of potency stems in part from the fact that those vaccine peptides do not boost T helper cells, which up-regulate the cytotoxic T lymphocytes and provide long-term immunological memory.
Antigen Express scientists had developed a novel method to stimulate T helper cells with a hybrid vaccine peptide linking the peptide recognized by T-helper cells through a simple chemical linker to an immunoregulatory segment of the Ii-protein (the Ii-Key peptide). MHC class II epitopes in such Ii-Key hybrid peptides are presented 200 times more effectively than the epitope-only peptide in vitro. In this paper Lea Kallinteris demonstrated a potent boost of response in immunized mice.
Dr. Eric von Hofe, President of Antigen Express said, "I am very pleased with the progress made by Lea Kallinteris and her colleagues in this technically very difficult study. She has obtained clear demonstration of the power of this technology in cancer vaccines and obtained convincing data in an advanced preclinical model. This offers good support for an Investigational New Drug (IND) filing to the FDA for clinical trials." Anna Gluskin, CEO of Generex Biotechnology, said, "This is a significant recognition of our scientists by the official Journal of the International Society for Biological Therapy of Cancer, which is governed by the principal cancer immunotherapists of the world. We have a platform of vaccine products for treatment of major diseases. In cancer, our focus is in breast and prostate cancers, melanoma and colorectal cancer. In infectious diseases our focus is on HIV and Asian bird influenza. We have had continuing discussions about these programs with major companies, toward how best to advance these technologies into clinical trials." 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(TM) device. The Company's flagship product, oral insulin (Oral-lyn(TM)), 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 http://www.generex.com/.
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