Based on these promising preclinical results, a phase I (first-in-man) clinical trial in patients with spinal cord injury was conducted, proving excellent safety and tolerability of a human anti-Nogo-A antibody. With the support of the Regenerative Medicine Technologies Platform of Wyss Zurich, the team will now produce a new batch of this therapeutic anti-Nogo-A antibody. This antibody will enable the critical transition to phase II clinical trials, aimed to determine clinical efficacy of the anti-Nogo-A antibody in patients with spinal cord injury.
Beyond the field of spinal cord injury, these clinical studies will serve as a model for other disorders where nerve fibers of the central nervous system become injured, and may thus have a broad impact for the treatment of neurological diseases in general. A positive outcome of the planned clinical trials would be a real breakthrough in neurology, neuroscience and the field of tissue regeneration and repair.
Download CeNeReg factsheet
Watch a related video produced by the Swiss Television (SRF) in 2014: Hoffnung für Gelähmte (in German)
FUNDING PARTNERS
Co-funded by the Horizon 2020 Framework Programme of the European Union
European Research Council
Swiss National Science Foundation
Christopher & Dana Reeve Foundation
Bettina Steiner
Project Leader
Bettina Steiner joined Wyss Zurich in December 2019 as Project Leader for CeNeReg. She holds a Master’s degree in Pharmaceutical Biotechnology from Zurich University of Applied Sciences in Wädenswil. With four years of professional experience in a contract development and manufacturing organization (CDMO), she specializes in cell line and upstream development and has expertise in DSP, QC, QA, regulatory affairs and the manufacturing of antibodies. In her previous role as Junior Project Manager, she led a project to develop a new biopharmaceutical. As Project Leader of CeNeReg, she is responsible for the management of drug production and supply for the phase II clinical study (NISCI). In this context, she manages subcontractors and interacts with clinical research organizations and European medical authorities.
Contact:
bettina.steiner@wysszurich.ch
Tel. +41 44 634 56 87