Printer Friendly
The Free Library
14,558,825 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

Atlantic Research Group Successfully Completes Work on Phase III Randomized, Multi-Center Clinical Trial Facilitating Lev Pharmaceuticals' BLA Submission.


STAUNTON, Va. -- Atlantic Research Group ("ARG") played a critical role in the BLA submission made to the U.S. Food and Drug Administration (FDA) by Lev Pharmaceuticals.

Lev Pharmaceuticals submitted a BLA to the FDA on July 31, 2007, after the completion of the pivotal U.S. Phase III trial of C1 inhibitor for the treatment of hereditary angioedema (HAE), to be marketed as Cinryze(TM). Lev relied on ARG's experienced staff and TrialVista(TM), ARG's recently launched Clinical Trial Management System (CTMS), to assist in the timely completion of the clinical trial.

"ARG was instrumental in helping Lev Pharmaceuticals meet timelines for our BLA submission to the FDA. Their dedicated, thorough work, management of multiple vendors, efficient monitoring teams and TrialVista(TM) CTMS implementation were critical assets for Lev Pharmaceuticals as we prepared for this filing," said Jason Bablak, Lev's Vice President of Regulatory Affairs & Product Development.

Lyle Camblos, ARG Managing Partner said, "This is an exciting time for HAE patients in the United States and we are excited to have been a part of the management of the clinical trial and subsequent BLA submission of Cinryze(TM)."

ARG also continues to assist Lev Pharmaceuticals' with roll-over studies being conducted until FDA approval for Cinryze(TM) is received.

About Lev Pharmaceuticals, Inc.

Lev Pharmaceuticals (OTC Bulletin Board: LEVP.OB) is a biopharmaceutical company focused on developing and commercializing therapeutic products for the treatment of inflammatory diseases. Lev's C1 inhibitor, proposed to be marketed as Cinryze(TM), has been granted orphan drug status and fast track designation status for the treatment and prevention of HAE.

For more information about Lev, Cinryze(TM), or HAE, please contact Lev directly at (212) 682-3096, or visit Lev's website at www.levpharma.com.

About Atlantic Research Group, Inc. (ARG)

Atlantic Research Group provides the highest quality clinical monitoring, project management and other clinical support services to biotechnology and pharmaceutical companies. ARG also recently launched TrialVista[TM], a web-based clinical trial management system which can be easily customized to meet individual study needs and reduce start-up costs.

For more information about Atlantic Research Group and TrialVista(TM) please contact Atlantic Research Group directly at 540-213-0150, or visit Atlantic Research Group's website at www.atlanticresearchgroup.com

COPYRIGHT 2007 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2007 Gale, Cengage Learning. All rights reserved.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Date:Sep 17, 2007
Words:370
Previous Article:Mars US Announces Support for Current Chocolate Standard of Identity.
Next Article:Commission Welcomes CFI Ruling Upholding Commission's Decision on Microsoft's Abuse of Dominant Market Position.
Topics:



Related Articles
Strategic management and policy framework for achieving business excellence--case studies of Indian companies.
Cafe Yumm! expansion hums.(Business)(The budding franchise's new site will open on Broadway in October)
Employee engagement.(The Scoop on Recruiting)
CAMA's Certificate in Agri-Marketing.(NEWS FROM MANITOBA)
Making rural connections.(FOCUS ON: RURAL LIFESTYLE)
Rural lifestyle media updates.(FOCUS ON: RURAL LIFESTYLE)
Nature is the best medicine: more hospitals are incorporating "healing gardens" and speeding patient recovery.(Your Health)
Easy Steals - Your Money and Your Life
Are Predators Waiting, Watching, and Engaging on Your Child's Social Networking Sites?
Why Managed Internet Security Subscriptions Are the Wave of the Future (Part 1 of 2)

Terms of use | Copyright © 2009 Farlex, Inc. | Feedback | For webmasters | Submit articles