CSL Behring Completes Enrollment of Phase III Clinical Study of C1 Inhibitor in Treating Hereditary Angioedema
King of Prussia, PA — 12 October 2007
CSL Behring announced today that it has completed patient enrollment of a Phase III clinical trial of human pasteurized C1-inhibitor (C1-INH) concentrate to treat patients with hereditary angioedema (HAE), a rare genetic disorder that can lead to painful and sometimes life-threatening attacks of edema (swelling) of the face, airway, abdomen, and extremities. An enrollment of 125 patients has been achieved. The study, called I.M.P.A.C.T. (International Multi-centre Prospective Angioedema C1-inhibitor Trial), is a multi-center, prospective, clinical trial conducted in more than 60 centers in North America, Europe, Australia, Israel and Latin America. The results of I.M.P.A.C.T. will be submitted to the United States Food and Drug Administration and to Health Canada in support of applications to license C1-INH concentrate for use in North America.
HAE is caused by the partial absence of functional C1 inhibitor in the blood. I.M.P.A.C.T. will assess whether replacing the C1 protein missing in patients with HAE through treatment with C1-INH can address the underlying mechanism of the disease. An estimated 6,000 to 10,000 Americans suffer from HAE, and yet there are currently no therapies approved in the United States for the treatment of acute attacks of HAE.
“Completion of enrollment in I.M.P.A.C.T. is an important milestone in our efforts to make C1-inhibitor available in North America,” said Christian Peters, MD, PhD, Senior Director and U.S. Head of Clinical Research and Development. “Our two decades of experience and successful track record of C1-inhibitor use in Europe will be critical as we develop this novel therapy to meet the unmet needs of HAE patients in the U.S. and Canada.”
CSL Behring has manufactured and sold C1-INH concentrate for over 20 years in Germany, Austria, Switzerland, and several other countries. There, it is licensed under the trade name Berinert® P for the treatment of acute HAE attacks. For more information about HAE, visit www.allabouthae.com.
The International Multi-centre Prospective Angioedema C1-inhibitor Trial (I.M.P.A.C.T.) evaluated in a prospective and double-blind fashion whether different doses of human pasteurized C1-INH concentrate leads to faster relief of acute symptoms of abdominal and facial attacks compared with placebo in patients with HAE. To be eligible for inclusion in the study, patients must be six years of age or older, have a diagnosis of C1-INH deficiency and a documented history of facial or abdominal attacks.
About Hereditary Angioedema (HAE)
HAE due to C1-INH deficiency is characterized by relapsing, self-limiting episodes of edema at various body sites—mostly subcutaneous tissue, the wall of the intestine, and the larynx. Patients who have abdominal attacks can experience episodes of severe pain, diarrhea, nausea, and vomiting caused by swelling of the intestinal wall. Attacks involving the face and throat can result in airway closure, asphyxiation and, if left untreated, death. HAE is caused by a genetic deficiency of C1-INH, which is inherited in an autosomal dominant manner.
About CSL Behring
CSL Behring is a global leader in the plasma protein biotherapeutics industry. Passionate about improving the quality of patients' lives, CSL Behring manufactures and markets a range of safe and effective plasma-derived and recombinant products and related services. The company's therapies are used in the treatment of immune deficiency disorders, hemophilia, von Willebrand disease, other bleeding disorders and inherited emphysema. Other products are used for the prevention of hemolytic diseases in the newborn, in cardiac surgery, organ transplantation and in the treatment of burns. The company also operates one of the world's largest plasma collection networks, ZLB Plasma. CSL Behring is a subsidiary of CSL Limited, a biopharmaceutical company with headquarters in Melbourne, Australia. For more information, visit www.cslbehring.com.
Sheila A. Burke
Director, Public Relations & Communications
Worldwide Commercial Operations