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GLYCOTOPE Moves FSH-GEX(TM) into Phase-II Clinical Development
(PresseBox) (Berlin, Germany, )
After successful completion of Phase I, the German biotech company GLYCOTOPE moves its glycooptimized therapeutic protein FSH-GEX(TM) into Phase II of clinical development in In-Vitro-Fertilisation.
FSH-GEX(TM) is based on Glycotope's unique and proprietary GlycoExpress(TM) platform of glycooptimized human cell lines. The follicle-stimulating hormone FSH-GEX(TM) is produced recombinantly with a fully human and optimized glycolysation. Phase I studies of FSH-GEX(TM) (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(TM) , CetuGEX(TM) and TrasGEX(TM) , we have now a strong clinical proof of concept for our unique GlycoExpress(TM) 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."
FSH-GEX(TM) is based on Glycotope's unique and proprietary GlycoExpress(TM) platform of glycooptimized human cell lines. The follicle-stimulating hormone FSH-GEX(TM) is produced recombinantly with a fully human and optimized glycolysation. Phase I studies of FSH-GEX(TM) (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(TM) , CetuGEX(TM) and TrasGEX(TM) , we have now a strong clinical proof of concept for our unique GlycoExpress(TM) 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."
Über GLYCOTOPE GmbH
GLYCOTOPE, founded in 2001 in Berlin, focuses on the development of innovative antibodies for the treatment of various cancer types, targeting glycostructures on cell surfaces. In addition, Glycotope develops so-called BioBetters, recombinant biopharmaceuticals with optimized and fully human sugar structures (via glycolysation), leading to improved efficacy, reduced immunogenicity and correspondingly improved patient outcome. The company's technologies will also enable a broadening of eligible patient populations and indications as well as improved cost-effectiveness. Glycotope currently has four products in clinical development stage. The company's additional pipeline includes preclinical proteins for various indications.
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.
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