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news.Glycotope has recruited first patient in FSH-GEX Phase 1 clinical trial in the Netherlands to investigate the safety, tolerability, dosing requirements and pharmacokinetics of the product.
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FSH-GEX is a follicle-stimulating hormone for in-vitro fertilisation and the treatment of anovulatory infertility.
FSH-GEX is based on GlycoExpress, Glycotope´s development and production platform of glycoengineered human cell lines.
Glycotope founder, CSO and CEO Steffen Goletz said 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 their first glycooptimized non-antibody product in the clinic, validating the broad applicability of GlycoExpress to not just antibodies but almost all glycosylated proteins.
"In addition, we are expecting that the first patients for TrasGEX, our glycooptimized Trastuzumab, will be enrolled within the next weeks," Goletz said.
"We then will have successfully completed our ambitious plans to bring four glycooptimized biopharmaceuticals into the clinic within a short time."