The Lancet Publishes Vasogen's ACCLA... (nd CEO of Vasogen. Aspreviously reporte...)

The Lancet Publishes Vasogen's ACCLAIM Results

Date:1/18/2008

nd CEO of Vasogen. "As previously reported, we expect that this publication will help to underpin our commercial activities with Celacade in the European Union, where it has already been approved, as well as the initiation of the ACCLAIM-II trial, our confirmatory trial in NYHA Class II patients being planned for the purpose of achieving regulatory approval in the United States."

The FDA has recommended that Vasogen use a Bayesian approach in the design of ACCLAIM-II, the Company's confirmatory trial. The Agency indicated that they were recommending this approach specifically because it would allow for the borrowing of statistical power from the ACCLAIM trial, and has the potential to substantially reduce the sample size required for a confirmatory study.

The planned trial design for ACCLAIM-II indicates that as few as 300 patients could provide sufficient data to confirm the NYHA Class II findings in the ACCLAIM trial, which demonstrated a 39% reduction (p=0.0003) in the risk of death or cardiovascular hospitalizations for patients receiving Celacade. Furthermore, the use of an adaptive clinical trial design also provides the flexibility to increase the sample size up to 600 patients, should additional data be required.

About The Lancet:

The Lancet's coverage is international in focus and extends to all aspects of human health. It aims to publish the best original primary research papers, and review articles of the highest standard. The Lancet articles are rigorously peer-reviewed and edited to ensure the scientific merit and clinical relevance of its diverse content. Drawing on an international network of advisers and contributors, The Lancet meets the needs of physicians by adding to their clinical knowledge and alerting them to current issues affecting the practice of medicine worldwide.

About Vasogen:

Vasogen is a biotechnology company engaged in the research and commercial development of therapies designed to target th
'/>"/>

0

GOOD

Page: 1 2 3 4 5
Related biology technology :

1. Circulation Publishes MERLIN TIMI-36 Data Showing Safety and Anti-Arrhythmic Effects of Ranexa(R)
2. Thomson Scientific Publishes Who Is Making The Biggest Splash? - A Quarterly Review of Scientific Literature on Drugs and Therapies From April - June 2007
3. Consortium publishes Phase II map of human genetic variation
4. Vasogen Provides an Update on ACCLAIM-II Preparations
5. China Kangtai Cactus Biotech Files 2nd Quarter 2007 10QSB and Announces Unaudited Quarterly Results
6. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
7. Healthcare Technologies Reports Loss for 2007 Second Quarter & Six Months Results
8. CNS Response Announces Fiscal Third Quarter 2007 Results
9. Skystar Bio-Pharmaceutical Announces Second Quarter 2007 Results
10. China Biopharmaceuticals Holdings Announces Second Quarter 2007 Financial Results
11. XTL Biopharmaceuticals Announces Financial Results for the Six Months Ended June 30, 2007

Post Your Comments:

The Lancet Publishes Vasogen's ACCLA...(nd CEO of Vasogen. Aspreviously reporte...)