BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

CSL Behring Presents Population Pharmacokinetic Model for Novel Recombinant Factor IX Hemophilia B Treatment That Supports Less Frequent Administration


7/3/2013 10:47:37 AM

Staying up-to-date has never been simpler. Sign up for the free GenePool newsletter today!

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.

(Logo: http://photos.prnewswire.com/prnh/20130627/NY39350LOGO )

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.

About Hemophilia
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/.

Media Contact:
Sheila A. Burke, Director, Communications & Public Relations
Worldwide Commercial Operations
CSL Behring
610-878-4209 (o)
484-919-2618 (c)
Sheila.Burke@cslbehring.com

SOURCE CSL Behring



Help employers find you! Check out all the jobs and post your resume.


Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES