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Since the proteins have an extremely short half life and are rapidly degraded by digestive enzymes, it has been difficult to develop an effective method for delivering a therapeutic agent (medication) to the affected area. To date, many such therapeutic agents have been marketed or are in development. Current methods of delivery include surgical insertion, rectal insertion, oral delivery, inhalation, and subcutaneous injection. The level of efficacy and the relative success of such delivery methods are, in many cases, limited by the ability to effectively target the disease site. This targeted delivery can be achieved through the use of targeting moieties and specific delivery vehicles.
The use of targeting moieties in therapy has been demonstrated in many areas of medicine. One of the first examples of the use of targeting moieties was the radio-labeled antibody (Wadsworth et al., J. Nucl. Med. 1990. 31:25-30). Radiolabeled antibodies are now used for radio-imaging, radio-immunotherapy, and radio-immunoscintigraphy. Antibodies have also been used for targeting a wide variety of drugs to specific cells. To achieve antibody specificity, monoclonal antibodies have been made that bind to specific receptors on the surface of diseased cells.
Another successful example of the use of targeting moieties in therapy is in the delivery of interleukin 2 (IL-2). IL-2 has been used to stimulate immune response in cancer patients. One drawback to the use of IL-2 in therapy is the short circulating half life of the protein. To address this problem, a poly-L-lysine derivative of IL-2 was prepared (Wagner et al., Blood 1997. 90:1206-1214). The poly-L-lysine peptide has also been coupled to a monoclonal antibody, targeting IL-2 to IL-2 receptors expressed on the surface of T-cells. While antibody-IL-2 constructs have been shown to induce a T-cell mediated immune response in humans, there are a number of side effects associated with antibody-mediated drug delivery. For example, it is not possible to directly monitor the
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