New facts disclosed on trial design and results
Cinfa Biotech S.L., the biosimilars company of Cinfa Group, reports further data of the clinical development program for its lead development candidate B12019, a biosimilar version of Neulasta® (INN: pegfilgrastim) to treat chemotherapy-induced neutropenia, during a poster presentation at the European Society for Medical Oncology (ESMO) Congress 2017 in Madrid, Spain, from September 8-12, 2017.
The poster 1573P titled: “Pharmacokinetic and Pharmacodynamic Comparability of B12019, a Proposed Pegfilgrastim Biosimilar” will be presented on Sunday, September 10, from 1:15 to 2:15 pm CEST in Hall 8; an abstract is now available at www.esmo.org.
The data to be presented will provide the scientific basis for submitting the EMA marketing authorisation application. The clinical development program for B12019 was based on scientific advice from EMA and included two clinical studies.
The pivotal study examined pharmacokinetic (PK) and pharmacodynamic (PD) comparability of 6 mg B12019 to 6 mg Neulasta®. The single-dose, randomised, double-blind, two-way cross-over study enrolled 172 healthy volunteers. The primary endpoints were the area under the plasma concentration-time curve (AUC) and the maximum concentration (Cmax) for PK and the area under the effect curve (AUEC) for absolute neutrophil count (ANC) for PD.
The supportive study examined immunogenicity and PD comparability of 3 mg B12019 and 3 mg Neulasta® in a multiple-dose, randomised, double-blind, three-period, two-sequence cross-over study in 96 healthy volunteers. Primary endpoints were AUEC for PD and anti-drug antibody rate (ADA) for immunogenicity.
All clinical endpoints were met in both studies.
PK comparability was demonstrated in the pivotal study, and PD comparability was demonstrated in both studies. No imbalance of ADA-positive samples was observed and neither anti-G-CSF nor neutralising antibodies were detected for B12019 or Neulasta® in both studies.
The clinical program confirmed the biosimilarity of B12019 and Neulasta® in highly sensitive clinical study settings, thereby verifying the high level of similarity as shown on bioanalytical level.
Cinfa Biotech is headquartered in Pamplona, Spain, with offices in Munich, Germany. Founded in 2013 and supported by the Cinfa Group, 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, Cinfa Group 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. Cinfa Group’s first subsidiary, Laboratorios Cinfa, has become a recognised leader in the Spanish pharmaceutical market. As part of the internationalisation strategy, the company also serves in currently over 50 countries and is further expanding.
For more information, please visit: http://www.cinfabiotech.com/
Cinfa Biotech S.L.
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Phone: +34 948 33 50 05
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