Combining the safety advantages of a recombinant protein with the advantages of fully human glycosylation
Glycotope’s FSH-GEX™ is the first fully human glycosylated recombinant FSH (follicle-stimulating hormone), expressed in human cells and glyco-optimized to mimic endogenous human FSH. FSH is responsible for follicle maturation and is administered during the onset of in vitro fertilization procedures to induce maturation of multiple oocytes for retrieval.
Most currently approved preparations of FSH are derived either from human urine or recombinant sources from non-human cells. Purification of FSH from urine is a very complex process and there are safety concerns with contaminations. A generally better safety profile today makes recombinant proteins the products of choice for most patients despite higher product costs and the fact that recombinant products may induce immunogenic or allergic reactions due to lack of human sugar structures.
Using GlycoExpress™, FSH-GEX™ has been developed to provide the safety advantages of a recombinant protein with the advantages of a fully human, optimized glycosylation. In a Phase II clinical trial for in vitro fertilization, FSH-GEX™ showed superior activity and excellent tolerability compared to the standard treatment, Gonal-f®. The data showed that FSH-GEX™, even at half the unit dose (75 IU FSH-GEX™), was at least as active as Gonal-f ® (150 IU) in all FSH-mediated parameters and endpoints.