CSL Behring today announced it will present study data from three ongoing clinical trial programs evaluating the Company’s novel recombinant factor VIIa (rVIIa-FP), VIII (rVIII-SingleChain) and IX (rIX-FP) agents for people with hemophilia A and B with and without inhibitors. The data will be presented at the International Society on Thrombosis and Haemostasis (ISTH) congress in Amsterdam. CSL Behring is the only company pursuing longer-acting rVIIa-FP and rIX-FP candidates based on recombinant albumin, and a rVIII-SingleChain compound that has been shown to improve the stability and half-life of factor VIII (FVIII).
CSL Behring will also sponsor the following two satellite symposia at ISTH:
- Spotlight on the future: New Options for our Patients on Sunday, June 30, 2013 from 4:15-6:15 p.m. in the Mondriaan IV conference room
- Bleeding Emergencies: Strategies for the Reversal of Old and New-Generation Oral Anticoagulants on Monday, July 1, 2013 from 6:45-8:15 p.m. in the Forum conference room
"We are steadily advancing an exciting clinical development program to evaluate novel longer-acting recombinant factor therapies to progress the care of people with hemophilia A and B," said Russell Basser, M.D., CSL Senior Vice President, Global Clinical Research & Development. "CSL Behring has a long history and proven expertise developing and delivering valuable therapies for the hemophilia community. Now, we look forward to providing updates on our promising recombinant pipeline, which includes innovative candidates for rVIIa-FP, rVIII-SingleChain and rIX-FP, at this meeting." CSL Behring is advancing its recombinant factor development program in collaboration with its parent company, CSL Limited (ASX: CSL).
Information on the studies to be presented is as follows:
Monday, July 1, 2013
- The Coagulation Factor XIIa Inhibitor rHA-Infestin-4 Potently Improves Outcome After Cerebral Ischemia/Reperfusion Injury in Rats (J. Krupka, et al.)
E-Poster #PA 1.10-2: 5:00 p.m. – 6:30 p.m.
- Inhibiting Coagulation Factor XIIa Potently Prevents Thrombosis in a Rabbit Arteriovenous Shunt Model (M. Fries, et al.)
E-Poster #PA 1.10-4: 5:00 p.m. – 6:30 p.m.
- The FXIIa Inhibitor rHA-Infestin-4 Safely Protects from Arterial and Venous Thrombosis in Rodent and Non-Rodent Species (F. May, et al.)
E-Poster #PA 1.10-6: 5:00 p.m. – 6:30 p.m.
- Quantitative Whole Body Autoradiography (QWBA) Study on the Effect of Albumin Fusion on the Biodistribution of Recombinant Factor rFIX (E. Herzog, et al.)
E-Poster #PA 1.12-1: 5:00 p.m. – 6:30 p.m.
- Functional Characterization of rVIII-SingleChain and Comparison with Commercially Available Recombinant FVIII Products (C. Horn, et al.)
E-Poster #PB 1.55-6: 5:00 p.m. – 6:30 p.m.
- Quantitative Whole Body Autoradiography (QWBA) Study on the Biodistribution of a Recombinant Factor rVIIa Linked to Human Albumin (E. Herzog, et al.)
E-Poster #PB 1.58-3: 5:00 p.m. – 6:30 p.m.
Tuesday, July 2, 2013
- Inhibition of Coagulation Factor XII Provides Thromboprotection in Extracorporeal Circulation Without Increasing Bleeding Risk (M. Larsson, et al.)
Abstract Symposium #AS 20.3: 2:00 p.m. – 2:15 p.m.
- Non-Clinical Safety and Efficacy of Prothrombin Complex Concentrates (PCC) for the Reversal of Dabigatran Mediated Anticoagulation (E. Herzog, et al.)
E-Poster # PB 2.48-3: 5:00 p.m. – 6:30 p.m.
- Pharmacokinetic Results From a Phase I/III Study of a Novel Recombinant Single-Chain Factor VIII (rVIII-SingleChain) Compared to Octocog Alfa in Severe Haemophilia A Patients (I. Pabinger, et al.)
E-Poster #PB 2.55-4: 5:00 p.m. – 6:30 p.m.
- N-Glycosylation of rVIII-SingleChain, a Novel Recombinant Single-Chain Factor VIII (S. Schmidbauer, et al.)
E-Poster #PB 2.55-6: 5:00 p.m. – 6:30 p.m.
Wednesday, July 3, 2013
- Efficacy, PK and Safety Results of a Phase I/II Clinical Trial of Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) in Previously Treated Patients with Hemophilia B (PROLONG - 9FP) (U. Martinowitz, et al.)
Oral Communications #OC 70.2: 2:45 p.m. – 3:00 p.m.
- Safety and Pharmacokinetics of a Recombinant Fusion Protein-Linking Coagulation Factor VIIa with Albumin (rVIIa-FP) in Healthy Volunteers (D. Bensen-Kennedy, et al.)
E-Poster #PB 3.37-5: 5:00 p.m. – 6:30 p.m.
- Population Pharmacokinetic Model for a Novel Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) in Hemophilia B Patients (R. Parasrampuria et al.)
E-Poster #PB 3.49-5: 5:00 p.m. – 6:30 p.m.
Thursday, July 4, 2013
- Thrombosis and Hemostasis in Mice Lacking Factor VII Activating Protease (FSAP) (S. Subramaniam, et al.)
Oral Communication #OC 84.4: 8:45 a.m. – 9:00 a.m.
- Pre-Clinical Safety and Prolonged Pharmacokinetic/Pharmacodynamic (PK/PD) Properties of a Recombinant Fusion Protein Linking Activated Coagulation Factor VII with Albumin (rVIIa-FP) (S. Zollner, et al.)
E-Poster #PA 4.15-4: 1:30 p.m. – 3:00 p.m.
- Pre-Clinical Pharmacokinetic/Pharmacodynamic (PK/PD) Characteristics of rVIII-SingleChain, a Novel Recombinant Single-Chain FVIII (S. Zollner, et al.)
E-Poster #PB 4.55-6: 1:30 p.m. – 3:00 p.m.
About CSL Behring
CSL Behring is a leader in the plasma protein therapeutics industry. Committed to saving lives and improving the quality of life for people with rare and serious diseases, the company manufactures and markets a range of plasma-derived and recombinant therapies worldwide. CSL Behring therapies are used around the world to treat coagulation disorders including hemophilia and von Willebrand disease, primary immune deficiencies, hereditary angioedema and inherited respiratory disease, and neurological disorders in certain markets. The company’s products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic diseases in the newborn. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. CSL Behring is a subsidiary of CSL Limited (ASX:CSL), a biopharmaceutical company headquartered in Melbourne, Australia. For more information, visit http://www.cslbehring.com/.
Sheila A. Burke, Director, Communications & Public Relations
Worldwide Commercial Operations