CSL Behring Presents Population Pharmacokinetic Model for Novel Recombinant
Factor IX Hemophilia B Treatment That Supports Less Frequent Administration
Recombinant albumin fusion platform forms basis of innovation
AMSTERDAM, July 3, 2013
AMSTERDAM, July 3, 2013 /PRNewswire/ --CSL Behring today presented a
population pharmacokinetic model for recombinant fusion protein linking
coagulation factor IX with albumin (rIX-FP) at the International Society on
Thrombosis and Haemostasis (ISTH) congress in Amsterdam. The model confirms
earlier results from the first-in-human dose escalation trial, which
demonstrated improved pharmacokinetics of rIX-FP, with prolonged half-life
compared to currently available factor IX.
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CSL Behring utilized a population PK approach to predict factor IX activity
levels after less frequent administration of rIX-FP to instruct future
clinical trials in which extended dosing regimens will be evaluated.
"The information gleaned from this PK model will be useful as we continue our
clinical research aimed at developing longer-acting recombinant products for
hemophilia," said Russell Basser, M.D., CSL Senior Vice President, Global
Clinical Research & Development Senior Vice President. "Developing novel
recombinant factor therapies with a longer half-life may result in less
frequent dosing for hemophilia patients."
CSL Behring, in collaboration with its parent company, CSL Limited(ASX: CSL),
is developing rIX-FP through its PROLONG-9 clinical trial program.
About the Population Pharmacokinetic Model
The population pharmacokinetic model was built using factor IX activity levels
from 37 patients with hemophilia B. The factor IX activity level for each
patient was measured using a validated one-stage clotting method after
administration of three dose levels (25, 50 and 75 IU/kg) of rIX-FP.
Additionally, the effects of age, body weight and baseline factor IX activity
on the PK of rIX-FP were evaluated. Model robustness was assessed using
nonparametric bootstrap and visual predictive check approaches.
Hemophilia is an inherited bleeding disorder characterized by prolonged or
spontaneous bleeding, especially into the muscles and joints. In nearly all
cases, it affects only males. The disease is caused by deficient or defective
blood coagulation proteins known as factor VIII or IX. The most common form of
the disease is hemophilia A, or classic hemophilia, in which the clotting
factor VIII is either deficient or defective. Hemophilia A affects
approximately 1 in 5,000 to 10,000 people. Hemophilia B is characterized by
deficient or defective factor IX. Hemophilia B affects approximately 1 in
25,000 to 50,000 people. The recommended treatment for patients who are factor
deficient is to treat by replacement factor therapy.
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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