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This section features CSL Behring news releases that are more than 18 months old. Click the tabs to select releases in your area of interest. Click Resources to find additional background material on CSL Behring.

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Bleeding Disorders

28 March 2012 Findings Confirm Benefits of Albumin in Treating Cirrhosis Patients Undergoing Large-Volume Paracentesis

Administration of albumin reduces morbidity and mortality in cirrhotic patients undergoing large-volume paracentesis due to severe ascites, according to a new meta-analysis published online today in Hepatology, the official journal of the American Association for the Study of Liver Diseases. Compared with alternative treatments, albumin, a natural plasma-derived protein that expands blood plasma volume, significantly reduced the circulatory dysfunction that often occurs after large-volume paracentesis and also significantly reduced the occurrence of hyponatremia (low blood sodium levels). In addition, risk of death was 36 percent lower in patients receiving albumin than in those receiving other treatments.

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24 February 2012 First patient screened in CSL Behring global Phase I/III study of recombinant single-chain factor VIII

Vienna, Austria, 23 February, 2012— CSL Behring has announced that the first patient has been screened in its recombinant coagulation single-chain factor VIII (rFVIII) trial, part of the AFFINITY clinical trial program. The CSL Behring rFVIII, called ‘rVIII-SingleChain’, is a novel molecule being studied for the treatment of hemophilia A. It is being developed by CSL Behring, in collaboration with its parent company, CSL Limited (ASX:CSL).

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16 February 2012 CSL Behring Receives FDA Orphan Drug Designation for rVIIa-FP, a Novel Therapy in Development to Treat Hemophilia A and Hemophilia B Patients Who Have Inhibitors

CSL Behring announced today that the company has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for its novel recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP). The Orphan Drug Designation is granted for the treatment and prophylaxis of bleeding episodes in patients with congenital hemophilia and inhibitors to coagulation factor VIII or IX. CSL Behring is developing this therapy in collaboration with its parent company CSL Limited (ASX: CSL).

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02 February 2012 International Phase I Trial Results of Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) Show All Pharmacokinetic Parameters Significantly Improved in Patients with Severe Hemophilia B

CSL Behring today announced the results of a Phase I study evaluating recombinant fusion protein linking coagulation Factor IX with albumin (rIX-FP) in patients with severe hemophilia B. Results of the study, which were presented during an oral session at the Gesellschaft für Thrombose- und Hämostaseforschung e.V. (GTH) congress in Switzerland, showed that rIX-FP was well tolerated in all patients and lasted longer in the body, due to its prolonged half-life, compared with current Factor IX treatment options.

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12 January 2012 First clinical trial site initiated in CSL Behring Phase II/III pivotal study of recombinant fusion protein linking coagulation factor IX with recombinant albumin

CSL Behring has announced that the first site has been initiated in its global phase II/III, multi-center study to evaluate the safety, efficacy and pharmacokinetics of recombinant fusion protein linking coagulation factor IX with recombinant albumin (rIX-FP). The site is located in Vienna, Austria. The prospective, open-label study will enroll adolescents and adults (12 – 65 years) who have hemophilia B. CSL Behring, in collaboration with its parent company, CSL Limited (ASX:CSL), is developing rIX-FP for the prophylaxis and treatment of bleeding episodes in patients with congenital Factor IX (FIX) deficiency as part of the PROLONG-9FP clinical study program.

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