Glycotope Enrolls First Patients in Phase I Trial for FSH-GEX™
After the two monoclonal antibodies GT-MAB 2.5-GEX™ and CetuGEX™, the German biotech company Glycotope GmbH has recently received approvals to initiate clinical trials for its first glycooptimized non-antibody protein therapeutic FSH-GEX™.
FSH-GEX™ is a follicle-stimulating hormone which will be developed for in vitro fertilization and the treatment of anovulatory infertility. It is produced recombinantly with a fully human glycosylation.
In April Glycotope has enrolled the first subjects into a phase I clinical trial in the Netherlands to evaluate the safety, tolerability, dosing requirements and pharmacokinetics of the product.
Based on GlycoExpress™, Glycotope´s development and production platform of glycoengineered human cell lines, FSH-GEX™ combines into one single product the safety advantages of a recombinant origin with the fully human nature of pharmaceuticals derived from urinary sources plus the glycooptimization of the molecule.
“After having 2 antibodies in clinical trials and a third antibody approved by the competent authority, starting the clinical phase for FSH-GEX™ is an important milestone for the company, as it is our first glycooptimized non-antibody product in the clinic, validating the broad applicability of GlycoExpress™ to not just antibodies but almost all glycosylated proteins”, states Dr. Steffen Goletz, CEO, CSO and Founder of Glycotope.
Goletz continued, “In addition, we are expecting that the first patients for TrasGEX™, our glycooptimized Trastuzumab, will be enrolled within the next weeks. We then will have successfully completed our ambitious plans to bring four glycooptimized biopharmaceuticals into the clinic within a very short time”.