The completion of randomization means that even the last patient is now being treated with FSH. This study milestone was completed on time and in less than five months after the inclusion of the first patient into the study (first patient in).

The Phase II, multicenter, multinational, randomized clinical trial is investigating the efficacy and safety of varying doses and dosing regimens of FSH-GEX™ in comparison with daily 150 IU Gonal-f^® in over 240 women undergoing ICSI treatment. The primary end point of the Phase II trial comprises follicular response; the secondary end points include number and quality of oocytes, implantation rate, pregnancy rates, and pharmacodynamic effects on biomarkers. The trial is expected to report at the beginning of Q4 2013 and the Phase III clinical trial is expected to start in the first half of 2014.

"Completing randomization in this first large Phase II trial with a fully human glycosylated and glycooptimized GlycoExpress™ product is a major milestone for us and our investors. Based on the superior activity of FSH-GEX™ seen in the first trials with human volunteers, we are keen to see its performance in the randomized patient setting.

"FSH-GEX™ is the first of our glycooptimized, fully human non-antibody molecules validating our unique GlycoExpress™ platform and proving our commitment to deliver better therapies to patients in an efficient, cost effective manner," said Dr Steffen Goletz, CEO, CSO and Founder of Glycotope.

The follicle-stimulating hormone FSH-GEX™ is based on Glycotope’s proprietary GlycoExpress™ platform of glycoengineered proprietary human cell lines and produced recombinantly with fully human and optimized glycosylation. FSH-GEX™ has proven to be safe and well tolerated in Phase I single and multiple dose escalation trials with healthy volunteers and thereby showed a highly improved efficacy in direct head-to-head comparisons with marketed recombinant and urinary FSH products.