AMDL receives Israeli patent for animal model for the evaluation of vaccines

May 18 2007

AMDL, Inc. has announced that it has received an important Israeli patent for an animal model for the evaluation of vaccines, which is a part of its unique Combination Immune Therapy (CIT) technology.

CIT is a technology owned by AMDL that may be useful in treating specific forms of cancer.

AMDL also has patents and patents pending claiming a novel model, and methods of using these models, derived through the CIT technology it believes will be far more useful than animal studies because AMDL's "humanized" mice have human-like immune systems. "Medical science has long been concerned about adverse occurrences in human trials that aren't predicted in traditional animal studies," said Gary Dreher, AMDL CEO. "With the novel animal models we have developed, some of these important concerns could be eliminated."

The "humanized" mouse as claimed by AMDL has been engineered to possess a human-like immune system. This "transgenic" mouse is extremely useful for studying the potential therapeutic benefits of candidate gene therapy compositions. Because the natural mouse immune system differs from the human immune system, experiments conducted in conventional mice are not always predictive of how new therapeutic compounds will work in humans. However, transgenic mice made in accordance with AMDL's patents have an immune system more like a human's. Results obtained from experiments using this mouse may correlate significantly better than traditional animal models. That is why these mice are referred to as "humanized mice."

CIT uses two genes in combination to build the body's immune system and to destroy cancer cells. The GM-CSF gene alters the tumor to activate tumor-specific T-cells within the immune system, while the B7-2 gene enters the tumor to stimulate larger and stronger T-cells to fight the cancer. This is a variation of the traditional concept of gene therapy, which seeks to replace damaged or abnormal genes with healthy ones. Replacing defective genes in cancer cells has proven impractical because of the number of genes involved.

CIT has undergone successful Phase I clinical trials in skin and brain cancer patients and was shown to be 100 percent effective in a humanized mouse model at the University of Alberta, Canada. Publications that have reported on this therapy include "Human Gene Therapy" and "Neurosurgery."

Currently AMDL holds patents for the "humanized mouse" in the U.S., Australia and Singapore. "The major pharmaceutical companies are searching for products in the multi-billion dollar global cancer market and we believe that CIT has significant, important features to offer to these firms," said Gary Dreher, AMDL President and CEO. AMDL is seeking a strategic partner for clinical trials, and eventual marketing, of CIT.

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