GLYCOTOPE Moves FSH-GEX™ into Phase-II Clinical Development
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|Friday, 08 June 2012 09:30 (UTC + 2)|
Berlin, Germany, June 08, 2012 / B3C newswire / – 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-Fertilisation.
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.”
Together with Glycotope-Biotechnology in Heidelberg, Glycotope evolved into a leading integrated glycobiology company, covering all phases in preclinical and clinical drug development and GMP production. With more than 150 employees and a strong and broad IP-platform, Glycotope has grown to one of the largest Biotech companies in Germany.