Atlantic Research Group Successfully Completes Work on Phase III Randomized, Multi-Center Clinical Trial Facilitating Lev Pharmaceuticals' BLA Submission
Posted on: Monday, 17 September 2007, 12:00 CDT
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 CinryzeTM. Lev relied on ARG's experienced staff and TrialVistaTM, 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 TrialVistaTM 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 CinryzeTM."
ARG also continues to assist Lev Pharmaceuticals' with roll-over studies being conducted until FDA approval for CinryzeTM 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 CinryzeTM, has been granted orphan drug status and fast track designation status for the treatment and prevention of HAE.
For more information about Lev, CinryzeTM, 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™, 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 TrialVistaTM please contact Atlantic Research Group directly at 540-213-0150, or visit Atlantic Research Group's website at www.atlanticresearchgroup.com
Source: Business Wire
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