2010 Volume 25 Issue 6 Pages 579-589
In recent years, nucleic acid medicines, such as antisense, decoy, siRNA and aptamer have been regarded as the targeted therapy for next generation. On the basis of many research results that elucidate functional mechanism of the nucleic acid medicines, efficacies of the medicines on various diseases have been verified and their development as pharmaceuticals and/or medical devices have been more and more expected. Besides, it is expected that application of the adequate DDS technique would enable to deliver the nucleic acid medicines to the targeted organ/tissue, which makes the medicines act on the targeted cell/molecule, and thus such application of the DDS technique would broaden indication of treatment by the nucleic acid medicines. However, there are several points to be considered in the development of the nucleic acid medicines, which are different from that of biologics and/or chemical drugs that do not have such concern generally. So, it is necessary for development of nucleic acid medicines to overcome such a variety of challenges.
In this review, challenges in the development of nucleic acid medicines for pharmaceuticals and investigation of DDS application for medical devices are introduced, focusing on the clinical development of NFκB decoy oligodeoxynucleotides.