CSL Behring to Premiere Data from Broad Recombinant Clinical Development
Program in Hemophilia at the International Society of Thrombosis and
Haemostasis (ISTH) Congress
Studies will feature research on novel investigational recombinant factor
VIIa, VIII and IX therapies for hemophilia A and B
KING OF PRUSSIA, Pa., June 27, 2013
KING OF PRUSSIA, Pa., June 27, 2013 /PRNewswire/ --CSL Behring today
announced it will present study data from three ongoing clinical trial
programs evaluating the Company's novelrecombinant 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
CSL Behring will also sponsor the following two satellite symposia at ISTH:
oSpotlight 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
oBleeding Emergencies: Strategies for the Reversal of Old and
New-Generation Oral Anticoagulants on Monday, July 1, 2013 from 6:30-8:00
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
oThe Coagulation Factor XIIa Inhibitor rHA-Infestin-4 Potently Improves
Outcome After Cerebral Ischemia/Reperfusion Injury in Rats (J. Krupka, et
E-Poster #PA 1.10-2: 5:00 p.m. – 6:30 p.m.
oInhibiting 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.
oThe 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.
oQuantitative 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.
oFunctional 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.
oQuantitative 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
oInhibition of Coagulation Factor XII Provides Thromboprotection in
Extracorporeal Circulation Without Increasing Bleeding Risk (M. Larsson,
Abstract Symposium #AS 20.3: 2:00 p.m. – 2:15 p.m.
oNon-Clinical Safety and Efficacy of Prothrombin Complex Concentrates (PCC)
for the Reversal of Dabigatran Mediated Anticoagulation (E. Herzog, et
E-Poster # PB 2.48-3: 5:00 p.m. – 6:30 p.m.
oPharmacokinetic 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.
oN-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
oEfficacy, 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.
oSafety 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.
oPopulation 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
oThrombosis 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.
oPre-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.
oPre-Clinical Pharmacokinetic/Pharmacodynamic (PK/PD) Characteristics of
rVIII-SingleChain, a Novel Recombinant Single-Chain FVIII (S. Zollner, et
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
SOURCE CSL Behring
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