Navigation Links
Octapharma Launches Clinical Trial to Evaluate Efficacy & Safety of wilate® In Preventing Surgical Bleeding in Type 3 von Willebrand Disease Patients
Date:9/26/2011

HOBOKEN, N.J. and LACHEN, Switzerland, Sept. 26, 2011 /PRNewswire/ -- Octapharma, one of the largest human protein products manufacturers in the world, has launched an international multi-center clinical study to investigate the efficacy and safety of wilate® (von Willebrand Factor/Factor VIII Concentrate, Human) in preventing excessive intra- and post-operative bleeding in pediatric and adult patients with Type 3 von Willebrand Disease (VWD) who undergo major surgical procedures.

The prospective, open-label, Phase 3 trial is being conducted at study centers in the U.S., Europe, Asia, and South Africa and recently enrolled its first patient. As the most common inherited bleeding disorder in humans, VWD affects one to two percent of the general population or approximately 3 million people in the United States. VWD is a complex congenital bleeding disorder that is divided into subtypes with Type 3 being the most severe form.

"The study will collect valuable information on this rare VWD patient subset," said Coordinating Investigator Craig Kessler, M.D., Georgetown University Hospital, Professor of Medicine and Pathology and Director of the Division of Coagulation. "Sufficient data is not currently available for Type 3 VWD patients. The research will be invaluable in determining the adequacy of dosing and duration of treatment in this group of patients."

Originally approved in Germany in 2005, wilate® is available in 46 countries worldwide. In December 2009, the U.S. Food and Drug Administration (FDA) granted Octapharma orphan drug exclusivity for wilate®, the first replacement therapy developed specifically for VWD.

wilate® is a plasma-derived, stable, highly purified concentrate of freeze-dried human von Willebrand factor (VWF) and coagulation factor VIII (FVIII). Two well-established virus inactivation steps are incorporated into the manufacturing process of wilate®, specifically a solvent/detergent (S/D) and terminal dry heat treatment.

For more information on the research, entitled "Clinical Study to Investigate the Efficacy and Safety of Human Factor VWF/VIII Concentrate (wilate®) in Subject with Inherited Type 3 Von Willebrand Disease (VWD) who Undergo Major Surgical Procedures (WONDERS)," please visit www.clinicaltrials.gov. U.S. researchers interested in participating in the study should contact Sylvia Werner, Octapharma Associate Director Clinical Operations – Coagulation, at (201) 604-1149 or sylvia.werner@octapharma.com.

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 or www.wilateusa.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
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Octapharma USA Sponsors International Advisory Board for Evaluating Treatment of Patients with von Willebrand Disease
2. Octapharma Targets Primary Immune Deficiency Research With Grant for The Mount Sinai Medical Center
3. 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
4. Octapharma Accepting Applications for Research Grants Focused on Human Protein Therapies
5. Octapharma USA Launches Web Resource for von Willebrand Disease Healthcare Professionals and Patients
6. FDA Confirms Orphan Drug Exclusivity Approval for wilate®, Octapharma USAs New Therapy for Common Inherited Bleeding Disorder
7. Octapharma USA Announces Availability and Distributors for wilate®, the First Replacement Therapy Developed Specifically for von Willebrand Disease
8. Octapharma Receives Orphan Drug Exclusivity Approval for wilate(R) - A Replacement Therapy Developed Specifically for von Willebrand Disease
9. Octapharma USA Announces FDA Approval of wilate(R) - the First Replacement Therapy Developed Specifically for von Willebrand Disease
10. Octapharma Group and Fresenius Kabi Enter Into an Exclusive License, Development and Supply Agreement for a HESylated Recombinant Protein
11. Octapharma Targeting the Major Risk of Hemophilia Treatment - FVIII Antibodies
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/6/2017)... --  Provista , a proven leader in the supply chain ... Jim Cunniff as the company,s new president and ... to Provista, including most recently serving as the president and ... . He assumed his new role with Provista on May ... Provista," says Jody Hatcher , president, Sourcing and Collaboration ...
(Date:5/4/2017)... , May 4, 2017  A recent ... Control, Ultraviolet-C light as a means ... SmartUVC,s ability to reduce bioburden on anesthesia workstations. ... reduction on high-touch, complex medical equipment surfaces contaminated ... infections. "This study further validates the ...
(Date:5/4/2017)... May 4, 2017  A new tight-tolerance microextrusion ... other highly-engineered materials, is being launched by Natvar, ... been developed in recent years to service a ... surgical applications. More expensive materials such as glass ... tubing due to their ability to consistently hold ...
Breaking Medicine Technology:
(Date:5/22/2017)... ... 22, 2017 , ... “Homeostasis: The Journey of a Manic-Depressive” tells the story ... Donald Rodriguez takes readers on a rollercoaster ride that includes a midnight trek to ... to a dark place where Donald considers suicide. Readers learn how Donald finally ...
(Date:5/22/2017)... ... May 22, 2017 , ... WeightZone ... Wellocity to empower WeightZone Factor members to track their exercise patterns, monitor behavioral ... health education, all on their mobile phones. It also provides social networks for ...
(Date:5/21/2017)... (PRWEB) , ... May 19, 2017 , ... ... pleased to announce the appointment of James (Jim) Vertino as Chief Information Officer ... a proven, transformational leader who drives innovation and business performance. He defines strategic ...
(Date:5/21/2017)... ... ... Pot. Reefer. Grass. Mary Jane. No matter what people call it, they ... before. More than a map, new social marketplace Weedable goes beyond providing ... for the first time – each other. A social marketplace like no other, Weedable ...
(Date:5/21/2017)... ... , ... For more than 20 years United Cutlery has been distinguished by ... from functional to fantasy. United Cutlery has always been “Stronger. Sharper” than the competition ... , Offering a range of weapons and tools built for battle, the M48 line ...
Breaking Medicine News(10 mins):