GlycoOptimized Follicle-Stimulating Hormone FSH-GEX (GT-GP 2.4-GEX)
The Follicle Stimulating Hormone (FSH) is responsible for follicle maturation. Its main clinical use is administration during the onset of in vitro fertilization procedures to induce maturation of multiple oocytes for retrieval.
Currently approved preparations of FSH stem from either urinary or recombinant sources from non-human cells. While urinary versions of FSH carry human glycosylation, the in general better biological safety of recombinant products makes them the product of choice for most patients, despite a non-human glycosylation profile and higher product costs associated with the treatment.
Glycotope’s glycooptimized version of FSH, FSH-GEX™ combines the advantages of both product types into one single product. With an improved activity by production in GlycoExpress™ and superior production yields, FSH-GEX™ provides the safety advantages of a recombinant protein with the activity advantages of FSH carrying fully human glycosylation and economic benefits of urinary preparations.
FSH-GEX has entered clinical phase II in Q1 /2013. Phase III is estimated to start in Q1 / 2014. Our own medical device is under develop.