Journal article

Granulocyte Colony-Stimulating Factor in Patients With Acute Ischemic Stroke Results of the AX200 for Ischemic Stroke Trial

E Bernd Ringelstein, Vincent Thijs, Bo Norrving, Angel Chamorro, Franz Aichner, Martin Grond, Jeff Saver, Rico Laage, Armin Schneider, Frank Rathgeb, Gerhard Vogt, Gabriele Charisse, Jochen B Fiebach, Stefan Schwab, Wolf R Schaebitz, Rainer Kollmar, Marc Fisher, Miroslav Brozman, David Skoloudik, Franz Gruber Show all

Stroke | LIPPINCOTT WILLIAMS & WILKINS | Published : 2013

Abstract

BACKGROUND AND PURPOSE: Granulocyte colony-stimulating factor (G-CSF; AX200; Filgrastim) is a stroke drug candidate with excellent preclinical evidence for efficacy. A previous phase IIa dose-escalation study suggested potential efficacy in humans. The present large phase IIb trial was powered to detect clinical efficacy in acute ischemic stroke patients. METHODS: G-CSF (135 µg/kg body weight intravenous over 72 hours) was tested against placebo in 328 patients in a multinational, multicenter, randomized, and placebo-controlled trial (NCT00927836; www.clinicaltrial.gov). Main inclusion criteria were ≤9-hour time window after stroke onset, infarct localization in the middle cerebral artery te..

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Funding Acknowledgements

Drs Schneider, Vogt, Kollmar, Laage, Schwab, and Schabitz are inventors of patent applications claiming the use of granulocyte colony-stimulating factor for the treatment of stroke. Drs Schneider, Vogt, Kollmar, Rathgeb, and G. Charisse are or were employees of SYGNIS Bioscience. The study was funded by SYGNIS Bioscience. Drs Ringelstein, Thijs, Norrving, Chamorro, Aichner, Grond, and Saver received fees and expenses from SYGNIS for their steering board work.