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ZLB Behring Release: New International Study Group Seeks To Set Standards For Prevention, Treatment Of Bleeding In Patients With von Willebrand Disease (VWD)


5/23/2006 11:17:36 AM

VANCOUVER, British Columbia, May 23 /PRNewswire/ -- The von Willebrand Disease Prophylaxis Network, an international study group made up of leading bleeding disorder experts from more than 70 centers around the world, today announced the start of a study examining the use and effect of prophylactic therapy in von Willebrand disease (VWD) patients who have a history of spontaneous bleeding events. The VWD International Prophylaxis (VIP) Study will evaluate several treatment protocols with a goal of establishing optimal preventive regimens for patients with VWD, the most common hereditary bleeding disorder in the world. The announcement was made during the 2006 World Federation of Hemophilia (WFH) Annual Congress in Vancouver.

The announcement follows the VWD Prophylaxis Network's finding that 77 percent of patients with Type 3 VWD had bleeding events in the past year that required treatment. The research also found that 22 percent of patients with Type 3 VWD had bleeding patterns severe enough to warrant preventive therapy. The findings were derived from the first international census to examine the use of prophylaxis in treating VWD, announced yesterday at the WFH Annual Congress.

"Until now, the prophylactic use of factor replacement therapies in VWD patients has not been thoroughly studied, and as such, optimal treatment regimens have not been established," said Erik Berntorp, MD, PhD, principal investigator and Professor, Department of Hematology and Coagulation Disorders, Malmo University Hospital, Malmo, Sweden. "By analyzing the use of medications used to prevent or control VWD bleeding, the VWD Prophylaxis Network hopes to offer the bleeding disorder community the answers needed to improve the quality of life of the 60 million people affected with VWD worldwide."

"Minimizing spontaneous bleeding events is critically important in the treatment of Type 3 VWD," said Miklos Fulop, chief executive officer and executive director of the World Federation of Hemophilia. "Our goal is treatment for all people with bleeding disorders, and to reach this goal, research is vitally needed. The Federation applauds the efforts of the VWD Prophylaxis Network, and we are sure that the knowledge gained will improve the lives of people with Type 3 VWD."

VIP Study Design

The VIP Study will enroll up to 200 patients in this multi-center prospective observational study. Each of four study arms will include up to 50 subjects. In some of the rarer bleeding indications, enrollment of 25 "completers" will provide sufficient information to support research conclusions. Each of the four study arms will focus on an important bleeding indication: joint, gastrointestinal (GI), menorrhagia, and epistaxis/oral. Subjects with VWD Type 1, 2, and 3 will be represented in the study (the spectrum from mild to severe disease). Participants will undergo an escalation of treatment from one to three dose levels of factor replacement therapy. All subjects will begin on the level 1 dose and remain on this dose for one year of follow-up, or until they meet the criteria for escalation to level 2 or 3. In the case of joint, gastrointestinal and epistaxis bleeding, patients will begin with 50U RCo/kg of a VWF/FVIII product once a week, escalating to twice a week at level two, and three times a week at level three; menorrhagia patients will commence with 50 U RCo/kg on day one of menses for two cycles, 50 U RCo/kg on days one and two of menses for two cycles in level two, and 50 U RCo/kg on days one, two and three of menses in level three. The choice of which VWF/FVIII product will be used is at the discretion of the investigator.

About von Willebrand Disease

Von Willebrand disease is caused by a deficiency or abnormality of the von Willebrand factor, a protein in the blood that is necessary for normal blood clotting. Men and women are equally likely to be affected by VWD. VWD is classified by types, ranging from Type 1 (the most common and mild) to Type 3 (the most severe). VWD affects about 60 million people worldwide.

Women with VWD are more likely to experience heavy, prolonged menstruation. Other common symptoms of VWD include frequent nosebleeds and easy bruising. Bleeding can be mild or serious and can occur as a result of injury, or without any obvious cause. More serious symptoms include bleeding into joints and internal organs. The VWD patient may require special care during dental procedures, surgery and childbirth.

There is no cure for VWD, but it can be treated. Specific treatments may include desmopressin acetate to release stored von Willebrand factor or von Willebrand factor replacement therapy, where required, with Humate-P(R), Antihemophilic Factor/von Willebrand Factor Complex (Human), the only product licensed by the FDA for the treatment of von Willebrand disease.

ZLB Behring's von Willebrand Factor (VWF) / factor VIII concentrate Humate-P(R) (marketed in Europe as Haemate(R) P) is a factor replacement therapy with more than 20 years of demonstrated safety and efficacy around the world. It is an injectable drug that works to achieve proper hemostasis by replacing the most active forms of VWF (high molecular weight VWF multimers) and factor VIII that are missing in patients with von Willebrand Disease (VWD).

Possible adverse events with the use of Humate-P include allergic reaction, urticaria (hives), chest tightness, rash, pruritus (itching) and edema (swelling). Anaphylactic reaction can occur in rare instances. Thromboembolic events have been reported in VWD patients receiving coagulation factor replacement therapy, especially in patients with known risk factors for thrombosis. In these patients, caution should be exercised and antithrombotic measures should be considered.

Humate-P is derived from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated. Please visit http://www.zlbbehring.com to read the prescribing information for Humate-P.

About the von Willebrand Disease Prophylaxis Network

Founded in 2001, the von Willebrand Disease Prophylaxis Network is an international study group of VWD physicians and researchers formed with the primary goal of investigating the role of prophylaxis measures that will protect against or prevent bleeding episodes in clinically severe VWD and educating healthcare professionals and consumers about VWD. The VWD Prophylaxis Network steering committee is made up of 14 top bleeding disorder physicians and researchers (six European, eight North American), including:

Chair: Erik Berntorp, MD, PhD, Malmo University Hospital, Sweden Co-Chair: Thomas Abshire, MD, AFLAC Cancer Center and Blood Disorders Service, US Data Coordination and Statistics: Sharyne Donfield, PhD, Rho, Inc., US -- Manuel Carcao, MD, Hemophilia Program, Hospital for Sick Children, Canada -- Joan Cox Gill, MD, The Blood Research Institute, US -- Jorge DiPaola, MD, Great Plains Regional Hemophilia Treatment Center, US -- Peter Kouides, MD, Mary M. Gooley Hemophilia Center, US -- Karin Kurnik, MD, Dr. von Haunersches-Children's Hospital, Germany -- Frank Leebeek, MD, Erasmus Medical Center, The Netherlands -- Stefan Lethagen, MD, Copenhagen Hemophilia Center, Denmark -- Michael Makris, MD, Royal Hallamshire Hospital, UK -- Pier Mannucci, MD, Angelo Bianchi Bonomi Hemophilia / Thrombosis Center, Italy -- Prasad Mathew, MD, Ted R. Montoya Hemophilia Center, US -- Rochelle Winikoff, MD, Ste-Justine Hospital, Canada

The VWD Prophylaxis Network is supported by an unrestricted grant from ZLB Behring.

About ZLB Behring

ZLB Behring is a global leader in the plasma protein biotherapeutics industry. Dedicated to improving the quality of life for patients throughout the world, ZLB Behring provides safe and effective plasma-derived and recombinant products and offers patients a wide range of related services. The company's broad portfolio of life-saving therapeutics is used in the treatment of individuals with hemophilia and other bleeding disorders, immune deficiency disorders and inherited emphysema; the prevention of hemolytic diseases for the newborn; cardiac surgery patients; and shock and burn victims. Additionally, ZLB Behring operates one of the world's largest fully-owned plasma collection networks. ZLB Behring is a subsidiary of CSL Limited, a biopharmaceutical company that operates worldwide from its headquarters in Melbourne, Australia. For more information, please visit http://www.zlbbehring.com. The website http://www.AllAboutBleeding.com is a resource dedicated to increasing awareness about VWD.

Media Contacts: Sheila A. Burke Director, Public Relations & Communications Worldwide Commercial Operations ZLB Behring +1-610-878-4209 Sheila.Burke@zlbbehring.com Tracy Pleva Hill MCS +1-800-477-9626 mobile: +1-908-642-5727 tracyph@mcspr.com

ZLB Behring

CONTACT: Sheila A. Burke, Director, Public Relations & CommunicationsWorldwide Commercial Operations of ZLB Behring, +1-610-878-4209,Sheila.Burke@zlbbehring.com; or Tracy Pleva Hill of MCS, 1-800-477-9626,mobile: +1-908-642-5727, tracyph@mcspr.com, for ZLB Behring



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