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Published on 1/31/2006 in the Prospect News Biotech Daily.

AMDL signs deal to develop trials for anticancer vaccine in Taiwan

By E. Janene Geiss

Philadelphia, Jan. 31 - AMDL, Inc. announced Tuesday that it has signed a memorandum of understanding with Vectorite Biomedica, Inc. that could lead to the development of human and animal clinical trials in Taiwan of AMDL's Combination Immunogene Therapy (CIT), a therapeutic anticancer vaccine.

"Vectorite introduced AMDL and its CIT technology to various senior officials from the Chang Gung Memorial Hospital and the National Taiwan University School of Veterinary Medicine and each has a significant interest in immediately beginning a clinical trial process, potentially including a fast-track Taiwan Food and Drug Administration approval of CIT," Gary L. Dreher, chief executive officer of AMDL, said in a company news release.

CIT uses two genes in combination to both build the body's immune system and to destroy cancer cells, officials said.

Its GM-CSF gene alters the tumor by activating tumor-specific T-cells within the immune system, while its B7-2 gene enters the tumor to stimulate stronger and larger T-cells to attack the cancer. The approach is potentially superior to traditional gene therapy, which seeks to replace damaged or abnormal genes with healthy ones, officials said. This has proven to be difficult because of the number of genes involved.

CIT was shown to be 100% effective in a humanized mouse model in previous clinical trials in Canada, officials said.

AMDL also said that CIT is synergistic to its DR-70 cancer test, giving the company both the ability to monitor and treat cancers.

AMDL said its primary objective remains receiving U.S. Food & Drug Administration clearance to market the DR-70, which would simultaneously increase market awareness and acceptance in the international marketplace.

Vectorite Biomedica is a Taiwan biotechnology company that uses innovative genetic tools for gene transfer, discovery functional genomics, deciphering disease pathways and drug validation.

AMDL, based in Tustin, Calif., is a company involved in the detection and treatment of cancer. The company developed and markets through exclusive distribution agreements the DR-70, a non-invasive cancer blood test that has demonstrated an ability to detect the presence in humans of up to 13 cancers 84% of the time overall.


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