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

   

First Patient Treated with Civacir® after Hepatitis C Induced Liver Transplantation in Biotest Pharmaceuticals's Phase III Clinical Trial


8/7/2013 9:27:44 AM

Get the latest biotech news where you want it. Sign up for the free GenePool newsletter today!

BOCA RATON, Fla. and DREIEICH, Germany, Aug. 7, 2013 /PRNewswire/ -- Biotest AG has achieved another milestone in the development of intravenous hyperimmune globulins. After treatment with virostatics over several weeks, the first patient underwent liver transplantation and subsequently was treated with the Civacirin the Phase III clinical trial. Civacir, a 10 % hepatitis C hyperimmune globulin developed and produced at Biotest Pharmaceuticals Corporation, a wholly owned subsidiary of Biotest AG, is being used in a clinical trial in North America in patients undergoing liver transplantation as a consequence of Hepatitis C infection.

End-stage liver disease due to hepatitis C virus (HCV) is a common indication for liver transplantation. However, newly transplanted livers are rapidly infected by any HCV viruses which are still circulating in the patient's body, resulting in a reinfection rate of around 80 % within 4 weeks after transplantation. Currently, there is no approved treatment available to prevent recurrence of the HCV virus after surgery since current antiviral regimens cannot be safely used after surgery due to toxicities, tolerability issues and drug-drug interactions within the first months after transplantation. Approximately 30% of these patients require a second liver transplant within 5 years.

The aim of this Phase III clinical trial (Study 988) is to evaluate the efficacy and safety as well as the pharmacokinetics of the agent in the HCV transplant population. Study 988 is being conducted at sites in the US and Canada, with a total of up to 90 patients to be enrolled.

Market exclusivity for 7 and 10 years after approval in the US and EU, respectively, is ensured by the Orphan Drug designation.

About Biotest AG
Biotest is a provider of pharmaceutical and biotherapeutic drugs. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialized primarily in the areas of application of clinical immunology, hematology and intensive medicine. In its Plasma Protein portfolio Biotest develops and markets immunoglobulins, coagulation factors and albumins based on human blood plasma. These are used for diseases of the immune and hematopoietic systems. Biotest also researches into the clinical development of monoclonal antibodies, including in the indications of rheumatoid arthritis and cancer of plasma cells. Biotest has more than 1.600 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.

About Biotest Pharmaceuticals Corporation
Biotest Pharmaceuticals Corporation, a wholly owned subsidiary of Biotest AG, researches, develops and manufactures biotherapeutic products with a specialization in immunology and hematology. BPC is a leader in the collection of source plasma and is currently involved in the development of plasma protein products and various hyperimmune (IG) products. The Company owns and manages twelve plasmapherisis centers across the United States and a state-of-the-art manufacturing facility in Boca Raton, Florida. The Company employs more than 700 people in the U.S.

Disclaimer
This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and assets position of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and are thus subject to risks and elements of uncertainty that could result in significant deviation of actual developments from expected developments. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.

SOURCE Biotest Pharmaceuticals Corporation



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