Dose-response endocrine profiles for a novel recombinant FSH preparation (FE 999049) derived from a human cell-line

Andersen, A. Nyboe; Barri, Pedro N.; Garcia-Velasco, J. A.; Sutter, P. De; Bosch, Ernesto; Arce, Julio César Legido

doi:10.1016/j.fertnstert.2013.07.179

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“…40 Results of a randomized, controlled, open-label, parallel-group, phase 2 study show a significant correlation between the dose of FE 999049 and both the number of oocytes retrieved and serum hormone levels. 40,41 The second rFSH preparation in development, FSH-GEX, is produced in a glycoengineered cell line (GlycoExpress), resulting in a glycosylation pattern expected to be identical to that of wild-type FSH. 42 Results of a randomized, active-controlled, phase 2 study in women undergoing controlled ovarian stimulation (n ¼ 247) showed that FSH-GEX treatment resulted in significantly higher numbers of cumulus-oocyte complexes than rFSH (least squares mean: 14.3 vs 10.9; P < .01), as well as a significantly higher numbers of MII oocytes (10.5 vs 8.4; P < .05).…”

Section: Development and Purification Of Fsh Preparations For Infertility Treatmentmentioning

confidence: 99%

Follicle-Stimulating Hormone: A Review of Form and Function in the Treatment of Infertility

Smitz

Wolfenson²,

Chappel

et al. 2016

Reprod. Sci.

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The use of gonadotropin therapy, including follicle-stimulating hormone (FSH), represents an indispensable part of fertility treatment. There are a number of FSH preparations commercially available or in development, including both urinary-derived products (urinary-derived FSH [uFSH]) and FSH produced through recombinant techniques (recombinant FSH [rFSH]). Differences in the glycosylation patterns of FSH give rise to a number of naturally occurring isoforms that may differ functionally. The relative concentrations of these isoforms vary over the course of the menstrual cycle and the lifetime, indicating that these differences in glycosylation may have physiologic relevance. Although both uFSH and rFSH contain human FSH, there are differences in the glycosylation patterns, which may give rise to differences in biologic activity between products. Current FSH products have been shown to have high purity and to exhibit consistent, favorable efficacy and safety profiles for the treatment of infertility, regardless of urinary or recombinant origin.

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Section: Development and Purification Of Fsh Preparations For Infertility Treatmentmentioning

confidence: 99%

Follicle-Stimulating Hormone: A Review of Form and Function in the Treatment of Infertility

Smitz

Wolfenson²,

Chappel

et al. 2016

Reprod. Sci.

View full text Add to dashboard Cite

show abstract

Dose-response endocrine profiles for a novel recombinant FSH preparation (FE 999049) derived from a human cell-line

Cited by 1 publication

References 0 publications

Follicle-Stimulating Hormone: A Review of Form and Function in the Treatment of Infertility

Follicle-Stimulating Hormone: A Review of Form and Function in the Treatment of Infertility

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