Hemophilia Treatment ACE910 Bypasses Factor VIII Inhibitor in Affinity Biologicals Plasmas
Chugai Pharmaceutical's newly developed antibody ACE910 is a potential lifesaving treatment for Hemophilia A patients who have developed Factor VIII inhibitors. A first-in-human study (1) recently published by the American Society of Hematology indicates that ACE910 may be a safe and effective treatment for hemophilia A patients.
Ancaster, Canada, December 11, 2015 --(PR.com)-- The first-in-human Phase I clinical trial measured the pharmacokinetics, pharmacodynamics, tolerability, and overall safety of ACE910. The study found that ACE910 successfully worked with other, endogenous clotting agents in order to form clots, as was intended. It was also found that ACE910's molecular structure is sufficiently different from human factor VIII that factor VIII inhibitors in the blood did not affect its function (2)
Factor VIII is a clotting agent produced by endothelial tissue and normally present in measurable quantities in the blood. People suffering from Hemophilia A either produce little to no factor VIII or the factor VIII they produce is defective (3). The condition is typically treated through self-administered injections of normal factor VIII.
Some individuals begin to produce antibodies to foreign factor VIII, or factor VIII inhibitors, that reduce the effectiveness of these injections. Assays are regularly performed on plasma from hemophilia A patients, compared to control plasmas manufactured by companies like Affinity Biologicals, to determine whether they have begun to produce factor VIII inhibitors.
The US Food and Drug Administration had given the Breakthrough Therapy Designation to ACE910 in mid-2015 for its potential as a lifesaving drug. The FDA Safety and Innovation Act of 20124 gave the regulatory agency authority to expedite research into pharmaceutical treatments for severe or life-threatening conditions. This designation indicates that the FDA believes that ACE910 is likely to be an effective treatment.
About Affinity Biologicals
Affinity Biologicals is a manufacturer of diagnostic and research products for the hemostasis, thrombosis, and coagulation fields. They specialize in deficient and control plasmas, polyclonal antibodies, EIAs, and ELISA kits for laboratory use. For more information on factor VIII inhibitor plasmas, visit http://www.affinitybiologicals.com/
1 http://www.bloodjournal.org/content/early/2015/11/30/blood-2015-06-650226?sso-checked=true
2 http://www.businesswire.com/news/home/20150903006647/en/Chugais-Bispecific-Antibody-ACE910-Treatment-Hemophilia-Designated
3 http://ghr.nlm.nih.gov/gene/F8
4http://www.fda.gov/RegulatoryInformation/Legislation/SignificantAmendmentstotheFDCAct/FDASIA/ucm20027187.htm
Factor VIII is a clotting agent produced by endothelial tissue and normally present in measurable quantities in the blood. People suffering from Hemophilia A either produce little to no factor VIII or the factor VIII they produce is defective (3). The condition is typically treated through self-administered injections of normal factor VIII.
Some individuals begin to produce antibodies to foreign factor VIII, or factor VIII inhibitors, that reduce the effectiveness of these injections. Assays are regularly performed on plasma from hemophilia A patients, compared to control plasmas manufactured by companies like Affinity Biologicals, to determine whether they have begun to produce factor VIII inhibitors.
The US Food and Drug Administration had given the Breakthrough Therapy Designation to ACE910 in mid-2015 for its potential as a lifesaving drug. The FDA Safety and Innovation Act of 20124 gave the regulatory agency authority to expedite research into pharmaceutical treatments for severe or life-threatening conditions. This designation indicates that the FDA believes that ACE910 is likely to be an effective treatment.
About Affinity Biologicals
Affinity Biologicals is a manufacturer of diagnostic and research products for the hemostasis, thrombosis, and coagulation fields. They specialize in deficient and control plasmas, polyclonal antibodies, EIAs, and ELISA kits for laboratory use. For more information on factor VIII inhibitor plasmas, visit http://www.affinitybiologicals.com/
1 http://www.bloodjournal.org/content/early/2015/11/30/blood-2015-06-650226?sso-checked=true
2 http://www.businesswire.com/news/home/20150903006647/en/Chugais-Bispecific-Antibody-ACE910-Treatment-Hemophilia-Designated
3 http://ghr.nlm.nih.gov/gene/F8
4http://www.fda.gov/RegulatoryInformation/Legislation/SignificantAmendmentstotheFDCAct/FDASIA/ucm20027187.htm
Contact
Affinity Biologicals
Hugh Hoogendoorn
(905) 304-9896
www.affinitybiologicals.com
Hugh Hoogendoorn
(905) 304-9896
www.affinitybiologicals.com
Contact
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