Cinfa Biotech S.L., the biosimilars company of Infarco group, today announced that an abstract has been published at the 58th Annual Meeting of the American Society of Hematology (ASH) in San Diego, CA, from December 3-6, 2016. Abstract publication number 5079 titled: “Demonstration of Pharmacokinetic and Pharmacodynamic Equivalence in Healthy Volunteers for B12019, a New Proposed Pegfilgrastim Biosimilar” reports further data from a clinical trial evaluating pharmacokinetic (PK) and pharmacodynamics (PD) equivalence of Cinfa Biotech’s lead development candidate B12019, a biosimilar version of Neulasta® (pegfilgrastim) to treat chemotherapy-induced neutropenia.
The single-dose, randomized, double-blind, cross-over study enrolled 172 healthy volunteers in Germany. It primarily investigated PK and PD of B12019 compared to Neulasta®.
The study met all of its primary endpoints for pharmacokinetics (PK): Area Under the Curve for concentration (AUC0-last) and Cmax; plus pharmacodynamics (PD): Absolute Neutrophil Count (ANC) and Area Under the Effect Curve (AUEC). For all endpoints, the Confidence Intervals (CI) for the Geometric Mean Ratio (GMR) were well contained within the pre-specified margins of 80 to 125%.
The safety profile of B12019 did not show any clinically meaningful difference as compared to Neulasta®. Neither anti-G-CSF nor neutralising antibodies were detected for both, B12019 and Neulasta®.
The full abstract can be accessed at: www.bloodjournal.org/
A poster presentation with full data from the trial will be delivered at the European Cancer Congress (ECCO) in Amsterdam, on 29 January 2017. ECCO runs from 27th to 30th January, 2017.
Cinfa Biotech is headquartered in Pamplona, Spain, with offices in Munich, Germany. Founded in 2013 and supported by its parent company Infarco, the Company is creating a pipeline of biosimilar drugs for a range of indications to address the growing need for affordable therapies based on proven science, quality, safety and efficacy. A complete team of experts with decades of in-depth experience is conducting product development, clinical studies, manufacturing and quality control, according to the highest European standards. Cinfa Biotech’s first product candidate in clinical development is B12019, a biosimilar version of Neulasta® (pegfilgrastim). The commercialisation models will be customised to the needs of partners and markets.
With 50 years’ experience, Infarco today employs over 1,400 people and reinvests an average of 90% of its annual profits in its portfolio companies, thereby driving their development and innovation. Infarco’s first subsidiary, Laboratorios Cinfa, has become a recognised leader in the Spanish pharmaceutical market. As part of the internationalization strategy, the company also serves in currently over 50 countries and is further expanding.
For more information, please visit: http://www.cinfabiotech.com
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