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Advances in recombinant DNA technology: corifollitropin alfa, a hybrid molecule with sustained follicle-stimulating activity and reduced injection frequency Fauser BC; Mannaerts BM; Devroey P; Leader A; Boime I; Baird DTHum Reprod Update 2009[May]; 15 (3): 309-21BACKGROUND: Recombinant DNA technologies have been used to develop longer-acting therapeutic proteins. One approach is to introduce sequences containing additional glycosylation sites. Using this technique, a new chimeric gene has been developed containing the coding sequences of the FSH beta-subunit and the C-terminal peptide of the hCG beta-subunit, which bears four O-linked oligosaccharide binding sites. Co-expression of the alpha-subunit and the chimeric FSH beta-subunit produces a new recombinant molecule, named corifollitropin alfa, with a prolonged elimination half-life and enhanced in vivo bioactivity compared with wild-type FSH. METHODS: Medline searches by subject and additional searching by hand. RESULTS: Initial studies in pituitary suppressed female volunteers confirmed the extended half-life of the compound. Phase II studies have shown that corifollitropin alfa is able to induce and sustain multi-follicular growth for an entire week in women undergoing ovarian stimulation using GnRH antagonist co-treatment for IVF. Corifollitropin alfa regimens have been developed with dosages of 100 and 150 microg, for patients with body weight 60 kg, respectively. CONCLUSIONS: Corifollitropin alfa is the first long-acting hybrid molecule with sustained follicle-stimulating activity developed for the induction of multi-follicular growth along with GnRH antagonist co-treatment for IVF. This new treatment option may be simpler and more convenient for patients compared with conventional long protocols of daily FSH injections in combination with GnRH agonist co-treatment. The safety and efficacy of such regimens is currently being evaluated in large comparative phase III clinical trials. The development of corifollitropin alfa is the first step towards a new generation of recombinant gonadotrophins.|Animals[MESH]|CHO Cells[MESH]|Cricetinae[MESH]|Cricetulus[MESH]|DNA, Recombinant/*chemistry[MESH]|Female[MESH]|Fertilization in Vitro[MESH]|Follicle Stimulating Hormone, Human/administration & dosage/pharmacokinetics/*pharmacology[MESH]|Follicle Stimulating Hormone/administration & dosage/pharmacokinetics/pharmacology[MESH]|Gonadotropin-Releasing Hormone/antagonists & inhibitors/pharmacology[MESH]|Half-Life[MESH]|Humans[MESH]|Injections, Subcutaneous[MESH]|Ovarian Follicle/*drug effects/growth & development[MESH]|Ovulation Induction/*methods[MESH]|Recombinant Fusion Proteins/*pharmacokinetics[MESH] |
