The US pharma company has received an Israeli patent for its genetically engineered mouse model, to add to those already gained for the US, Australia and Singapore. The transgenic mouse is designed to have a more human-like immune system. "Medical science has long been concerned about adverse occurrences in human trials that aren't predicted in traditional animal studies," said Gary Dreher, CEO of AMDL. "With the novel animal models we have developed, some of these important concerns could be eliminated." Since the natural mouse immune system differs from that in humans, experiments in mice are not always predictive of how therapeutic compounds will work in humans - both in terms of efficacy and side-effects. To combat this, AMDL has developed its 'humanised' mouse, which is part its Combination Immune Therapy (CIT) technology. In the case of cancer, most gene therapies have attempted all the defective genes in tumour cells, a move that AMDL described as "theoretically and practically impossible", due to the number of genes involved. Instead, AMDL's CIT targets cancer cells for immunological attack, while simultaneously stimulating a stronger immune response. This is done by combining two genes together: the granulocyte-macrophage colony-stimulating factor (GM-CSF) gene to attract antigen-presenting cells to activate a tumour specific immune response; and the B7-2 gene to produce a larger number of stronger immune T-cells to attack the cancer, thus increasing the immune response. CIT has been tested in Phase I clinical trials in patients with skin and brain cancer and, using AMDL's humanised mouse model, was show to be 100 per cent effective in a study run at the University of Alberta, Canada - where Dr Lung-Ji Chang developed CIT before it was acquired by AMDL in 2001. Since then, Dr Chang has continued to work on the technology as a consultant for AMDL. AMDL is currently seeking a partner for further clinical trials of CIT. "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 these firms," said Dreher.
