In recent years many new engineered protein therapeutics are being developed and tested in clinical trials (Marshall et al. 2003). Many early protein drugs showed limited applicability due to short half-life or low affinity to their receptors. Recombinant DNA technology permitted engineering protein molecules with specific chemical and biological characteristics. It is now anticipated that engineered hormone analogs will largely exceed clinical efficacy of existing products, including recombinant human TSH (rec-hTSH; Thyrogen™, Genzyme). Preclinical development of superactive TSH analogs can be divided into three phases: the TSH structure-function phase, the discovery phase and the optimization phase. It is apparent that detailed structure-function studies of TSH provided important foundation for rational modifications of human TSH molecule. This chapter describes the past, presence and future of superactive analogs of TSH with high receptor binding affinity. Such superactive analogs of TSH are expected to provide not only more efficacious diagnostic methods, but should also serve as indispensable tools in management of thyroid carcinomas with low TSH receptor number, impaired coupling and deficient ligand binding.
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