Date: 2012-06-08
Type of information:
phase: 2
Announcement: initiation
Company: Glycotope (Germany)
Product: FSH-GEX™ (glycooptimized follicle-stimulating hormone)
Action mechanism:
Disease: in vitro fertilisation
FSH treatment of female infertility
Therapeutic area: Gynecology - Women's health
Country:
Trial details:
Latest
news: The German biotech company GLYCOTOPE has moved its glycooptimized therapeutic protein FSH-GEX™ into Phase 2 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.
