Navigation Links
Octapharma Clinical Trial Begins in the U.S. and Germany Treating Hemophilia A Patients with First Recombinant Factor VIII Derived from a Human Cell-Line
Date:11/1/2010

HOBOKEN, N.J., Nov. 1, 2010 /PRNewswire/ -- Octapharma AG, one of the largest human protein products manufacturers in the world, and Octapharma USA today announced that patients diagnosed with severe hemophilia A have started treatment in a multi-center study that is researching the use of the first recombinant Factor VIII (rFVIII) derived from a human cell line (Human-cl rhFVIII). Researchers are investigating Human-cl rhFVIII, to assess pharmacokinetics, efficacy, safety and immunogenicity for previously treated patients with severe hemophilia A.

The National Institutes of Health estimate that 90 percent of all hemophilia patients have hemophilia A, also known as Factor VIII deficiency, and 70 percent of those have the severe form of the illness.

The prospective, randomized, actively controlled, open label Phase 2 trial is being held at research centers in the US and Germany under the title "Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of human-cl rhFVIII, a Newly Developed Human Cell-Line Derived Recombinant FVIII Concentrate in Previously Treated Patients with Severe Hemophilia A." The study started in spring 2010 and patient enrollment is well underway. Please visit www.clinicaltrials.gov for details.

Human-cl rhFVIII is a fourth-generation recombinant factor VIII (rFVIII) concentrate developed by Octapharma for the control and prevention of bleeding episodes and for surgical prophylaxis in patients with hemophilia A.  Human-cl rhFVIII is produced in genetically modified Human Embryonic Kidney (HEK) 293F cells. Human-cl rhFVIII is currently the only rFVIII, which has a human glycosylation pattern. Today, the development of antibodies against infused FVIII represents the most devastating complication in modern hemophilia A replacement therapy. The human glycosylation pattern in Human-cl rhFVIII might make it possible to avoid potentially immunogenic epitopes as expressed by hamster cells. Although clinical data have not yet been reviewed and verified by the U.S. Food and Drug Administration, the study aims to show an improved safety and long-term reduced immunogenicity of Human-cl  rhFVIII.

Human-cl rhFVIII is concentrated and purified for virus inactivation/removal although the cell bank and end of production cells have been extensively tested to ensure they are free of any endogenous or infectious viruses. The process ensures that any theoretical virus contamination is safely inactivated and/or removed. The manufacturing of Human-cl rhFVIII is completely free of animal or human derived added materials. The clinical development plan for Human-cl rhFVIII follows the requirements of the U.S. Food and Drug Administration and European guidelines.

About the Octapharma Group

Headquartered in Lachen, Switzerland, Octapharma AG is one of the largest human protein products manufacturers in the world and has been committed to patient care and medical innovation for over 27 years. Octapharma's core business is the development, production and sale of high quality human protein therapies from both human plasma and human cell-lines, including immune globulin intravenous (IGIV). In the U.S., Octapharma's IGIV product, octagam® (immune globulin intravenous [human] 5%), is used to treat disorders of the immune system, and Octapharma's Albumin (Human)® is indicated for the restoration and maintenance of circulating blood volume. Octapharma's wilate® received orphan drug exclusivity from the U.S. Food and Drug Administration (FDA) for the treatment of von Willebrand disease (VWD). Octapharma employs over 4,000 people and has biopharmaceutical experience in 80 countries worldwide, including the United States, where Octapharma USA is located in Hoboken, N.J.  Octapharma operates two state-of-the-art production sites licensed by the FDA, providing a high level of production flexibility. For more information, please visit www.octapharma.com.

Forward-looking statements

This news release contains forward-looking statements, which include known and unknown risks, uncertainties and other factors not under the company's control. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. These factors include results of current or pending research and development activities and actions by the FDA or other regulatory authorities.


'/>"/>
SOURCE Octapharma USA
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Plasma Products Safe Despite Swine Influenza Outbreak, Assures International Biopharmaceutical Company Octapharma
2. Octapharma Accepting Applications for Research Grants on Immunotherapy, Coagulation Disorders and Critical Care
3. Octapharma Targeting the Major Risk of Hemophilia Treatment - FVIII Antibodies
4. Octapharma USA Announces FDA Approval of wilate(R) - the First Replacement Therapy Developed Specifically for von Willebrand Disease
5. Octapharma Group and Fresenius Kabi Enter Into an Exclusive License, Development and Supply Agreement for a HESylated Recombinant Protein
6. Octapharma Receives Orphan Drug Exclusivity Approval for wilate(R) - A Replacement Therapy Developed Specifically for von Willebrand Disease
7. Octapharma USA Announces Availability and Distributors for wilate®, the First Replacement Therapy Developed Specifically for von Willebrand Disease
8. FDA Confirms Orphan Drug Exclusivity Approval for wilate®, Octapharma USAs New Therapy for Common Inherited Bleeding Disorder
9. Octapharma USA Launches Web Resource for von Willebrand Disease Healthcare Professionals and Patients
10. Octapharma Accepting Applications for Research Grants Focused on Human Protein Therapies
11. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... , June 23, 2016  In a startling report released ... failing their residents by lacking a comprehensive, proven plan to eliminate ... a definitive ranking of how states are tackling the worst drug ... only four states – Kentucky , ... Vermont . Of the 28 failing states, three – ...
(Date:6/23/2016)... , June 23, 2016 Bracket , a ... its next generation clinical outcomes platform, Bracket eCOA (SM) ... on June 26 – 30, 2016 in Philadelphia ... electronic Clinical Outcome Assessment product of its kind to fully ... Bracket eCOA 6.0 is a flexible platform for ...
(Date:6/23/2016)... -- Guerbet announced today that it has been named a ... One of 12 suppliers to receive the ... of Premier members through exceptional local customer service and ... lower costs. "We ... customer service from Premier," says Massimo Carrara , ...
Breaking Medicine Technology:
(Date:6/27/2016)... Overland Park, KS (PRWEB) , ... June 27, 2016 , ... ... leader in retailers of Eyeglasses . , Millions of individuals in the United ... life, eyeglasses have become a way to both correct vision and make a fashion ...
(Date:6/26/2016)... ... June 26, 2016 , ... Brent Kasmer, a legally blind and certified personal trainer ... through a fitness app. The fitness app plans to fix the two major problems leading ... a one size fits all type program , They don’t eliminate all the ...
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture animations, FCPX users ... - CEO of Pixel Film Studios. , ProHand Cartoon’s package transforms over 1,300 ... Pro X . Simply select a ProHand generator and drag it above media or ...
(Date:6/25/2016)... , ... June 25, 2016 , ... Conventional wisdom preaches ... success. In terms of the latter, setting the bar too high can result in ... than just slow progress toward their goal. , Research from PsychTests.com ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Pulmonary Hypertension Association ... it will receive two significant new grants to support its work to advance ... 25th anniversary by recognizing patients, medical professionals and scientists for their work in ...
Breaking Medicine News(10 mins):