Generex Biotechnology Corporation (OTCPK:GNBT) announced it would stage the Phase I trial of its cancer immunotherapy in China. The trial will be performed in collaboration with Dr. Daopei Lu and the Beijing Daopei Hospital in Beijing, China. Dr. Lu, a hematologist-oncologist, has conducted many clinical trials and authored over 200 articles in peer-review journals.
The immunotherapy demonstrated a robust anti-tumor immunity in a variety of mouse tumor models. Also, the RNAi approach developed at Antigen Express did not display any safety problems.
Generex said that Dr. Minzhen Xu, Vice President of Biology at Antigen Express, Inc., the immunotherapy subsidiary of Generex, will speak at an upcoming scientific symposium. He will discuss the pre-clinical studies performed by Antigen Express in preparation for its clinical trials in China .
The title of his presentation will be "Inhibition of MHC class II-associated Invariant Chain Generates Potent Tumor Cell Vaccine." It will be given at the 12th World Congress on Advances in Oncology to be held at the Creta Maris Hotel, Hersonissos, Crete, Greece, from Oct. 11 through the 13th.
The conference will focus on a variety of aspects of tumor biology and therapeutics. Dr. Xu will co-Chair and present in the Experimental Therapeutics/Vaccines section on Oct. 13th.
The new drug candidate seeks to force tumor cells to express tumor associated antigens in a way that makes them more visible to the immune system. This is done by using RNAi to suppress expression of the MHC class II-associated invariant chain in tumor cells. MHC class II molecules are naturally expressed in many cells of the body including some types of cancer cells. The invariant chain prevents class II molecules from associating with antigenic peptides in the cytoplasm of cells (where tumor associated antigens are found) and presenting them for recognition by T helper cells. Antigen-specific stimulation of T helper cells is pivotal in allowing the immune system to recognize novel pathogenic agents. While a number of groups have demonstrated the efficacy of this strategy in pre-clinical models, Antigen Express has developed proprietary methods using RNAi that make this approach feasible in the clinic.
Antigen Express focuses on vaccines. The company currently has an immunotherapeutic peptide in Phase II clinical trials for breast cancer and in Phase I trials for H5N1 avian influenza.
The parent company, Generex, concentrates on drug delivery systems. It has developed the RapidMist(tm) device, a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The technology allows oral administration for drugs that are usually administered by injection. Instead, the drugs are absorbed through the lining of the inner mouth.
An oral insulin product is approved in Ecuador and in clinical trials around the globe.