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Cinfa Biotech publishes clinical data abstract at the 58th American Society of Hematology (ASH) Annual Meeting 2016
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Cinfa Biotech publishes clinical data abstract at the 58th American Society
of Hematology (ASH) Annual Meeting 2016
02.12.2016 / 09:45
The issuer is solely responsible for the content of this announcement.
Cinfa Biotech publishes clinical data abstract at the 58th American Society
of Hematology (ASH) Annual Meeting 2016
02.12.2016 / 09:45
The issuer is solely responsible for the content of this announcement.
---------------------------------------------------------------------------
Cinfa Biotech publishes clinical data abstract at the 58th American Society
of Hematology (ASH) Annual Meeting 2016
Pamplona, Spain, 02 December 2016 - 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(R) (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(R).
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(R). Neither anti-G-CSF nor neutralising
antibodies were detected for both, B12019 and Neulasta(R).
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.
About Cinfa Biotech
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(R)
(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
For press enquiries:
MC Services AG
Julia von Hummel
Phone: +49 89 210 228-0
Email: cinfabiotech[at]mc-services.eu
---------------------------------------------------------------------------
02.12.2016 Dissemination of a Corporate News, transmitted by DGAP - a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
The DGAP Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Archive at www.dgap.de
---------------------------------------------------------------------------
526229 02.12.2016
Cinfa Biotech publishes clinical data abstract at the 58th American Society
of Hematology (ASH) Annual Meeting 2016
Pamplona, Spain, 02 December 2016 - 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(R) (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(R).
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(R). Neither anti-G-CSF nor neutralising
antibodies were detected for both, B12019 and Neulasta(R).
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.
About Cinfa Biotech
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(R)
(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
For press enquiries:
MC Services AG
Julia von Hummel
Phone: +49 89 210 228-0
Email: cinfabiotech[at]mc-services.eu
---------------------------------------------------------------------------
02.12.2016 Dissemination of a Corporate News, transmitted by DGAP - a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
The DGAP Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Archive at www.dgap.de
---------------------------------------------------------------------------
526229 02.12.2016
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