Glycotope Moves FSH-GEX™ into Phase-II Clinical Development
Product News Jun 08, 2012
After successful completion of Phase I, the German biotech company Glycotope moves its glycooptimized therapeutic protein FSH-GEX™ into Phase II of clinical development in In-Vitro-Fertilization.
FSH-GEX™ is based on Glycotope’s unique and proprietary GlycoExpress™ platform of glycooptimized human cell lines.
The follicle-stimulating hormone FSH-GEX™ is produced recombinantly with a fully human and optimized glycolysation.
Phase I studies of FSH-GEX™ (single dose escalation, multiple dose escalation) have been successfully completed, showing no toxicity and providing in a direct head-to-head comparison strong signals for highly improved efficacy vs. marketed urinary and recombinant products.
The current market value of FSH treatment of female infertility is USD 1.7 billion, reflecting the high medical need in this therapeutic area.
“We continue to deliver” states Dr. Steffen Goletz, CEO, CSO and Founder of Glycotope. “Beside our ongoing clinical antibody programs with PankoMab™, CetuGEX™ and TrasGEX™, we have now a strong clinical proof of concept for our unique GlycoExpress™ platform in non-antibodies, further underlining the substantial medical and commercial potential of our proprietary technology”.
Dr. Franzpeter Bracht, CFO & CBO adds: “This is another milestone reached for Glycotope, demonstrating our capability to build a strong and competitive product portfolio, offering the opportunity for substantial value for patients and our business partners.”