Pamplona, Spain, 26. September 2016 - Cinfa Biotech S.L., the biosimilars company of Infarco group, today announced the start of the second clinical study with its lead development candidate B12019, a biosimilar version of Neulasta(R) (pegfilgrastim) to treat chemotherapy-induced neutropenia. The objective of the trial is to investigate the pharmacodynamics (PD) and immunogenicity of B12019 compared to Neulasta(R).
The multiple-dose, randomised, double-blind, cross-over study will enrol 96 healthy volunteers in Germany. Secondary endpoints of the trial include pharmacokinetic (PK) and safety parameters. The study design is based on scientific advice from the European Medicines Agency (EMA) and is tailored to the specific properties of pegfilgrastim.
Dr. Ruediger Jankowsky, Managing Director of Cinfa Biotech GmbH, commented: "The successful clinical trial of B12019, which we reported in July this year, allowed for the immediate continuation of the clinical development program, especially since proving that we have such a high-quality product and a confirmed development strategy. The timely start of the second clinical study marks an important milestone in the development of B12019."
Read more: http://www.dgap.de/dgap/News/corporate/cinfa-biotech-starts-second-clinical-study-pegfilgrastim-biosimilar-candidate-b/?newsID=963037