Vasogen Provides Update on ACCLAIM II Program

    MISSISSAUGA, ON, March 17 /CNW/ - Vasogen Inc. (NASDAQ:  VSGN; TSX: VAS)
today announced that on Friday, March 14, it had an initial teleconference
with the FDA to discuss and clarify the recent comments from the agency
regarding the use of a Bayesian approach for ACCLAIM II, a clinical trial
which is being planned to support an application for U.S. market approval of
the Celacade(TM) System for the treatment of patients with New York Heart
Association (NYHA) Class II heart failure.
    The teleconference with the FDA follows an announcement by the Company on
March 3rd, stating that the FDA disagrees with the use of a Bayesian approach
for the planned ACCLAIM II study. This is contrary to the FDA's original
communication to Vasogen recommending a Bayesian study design.
    "Dr. Donald Berry, an expert in Bayesian trial design, and Dr. James
Young, a leading heart failure specialist with extensive expertise in the
design and conduct of clinical trials in heart failure, joined our internal
team to help clarify and address the issues raised by the agency," commented
Chris Waddick, President and CEO of Vasogen. "Having discussed with the FDA
their concerns, we are now preparing a written response to the FDA's comments
and would expect to submit this to the agency during the next week - we will
continue to update shareholders as appropriate."
    Dr. Donald A. Berry, Head, Division of Quantitative Sciences and
Chairman, Department of Biostatistics, The University of Texas MD Anderson
Cancer Center, and a world recognized authority in the area of Bayesian and
adaptive trial design has been assisting Vasogen throughout the development of
ACCLAIM II study design. Dr. James B. Young, Chairman, Division of Medicine at
the Cleveland Clinic Foundation and Medical Director, Kaufman Center for Heart
Failure is Chairman of the ACCLAIM II Steering Committee. Dr. Young, who has
played a leading role in numerous multi-center clinical trials focusing on
heart failure and transplantation, led Vasogen's 2,400-patient ACCLAIM study
which was completed last year and demonstrated a 39% reduction (p=0.0003) in
the risk of death or cardiovascular hospitalizations for the large pre-defined
subgroup of 689 patients with NYHA class II heart failure.

    About Vasogen:

    Vasogen is a biotechnology company engaged in the research and commercial
development of therapies designed to target the destructive inflammatory
process associated with the development and progression of cardiovascular and
neurodegenerative disorders. The Company's lead product, the Celacade(TM)
System, is designed to activate the immune response to apoptosis - an
important physiological process that regulates inflammation. Celacade has
received European regulatory approval under the CE Mark for chronic heart
failure and is being marketed in the EU by Grupo Ferrer Internacional, S.A.
Celacade is also in late-stage clinical development for the treatment of
chronic heart failure in the United States. Vasogen is also developing a new
class of drugs for the treatment of certain neuro-inflammatory disorders.
VP025 is the lead candidate from this new class of drugs.

    Certain statements contained in this press release, or elsewhere in our
public documents constitute "forward-looking statements" within the meaning of
the United States Private Securities Litigation Reform Act of 1995 and/or
"forward-looking information" under the Securities Act (Ontario). These
statements may include, without limitation, plans to advance the development
of Celacade(TM) or VP025, plans to fund our current activities, statements
concerning our partnering activities, health regulatory submissions, strategy,
future operations, future financial position, future revenues and projected
costs. In some cases, you can identify forward-looking statements by
terminology such as "may", "will", "should", "expects", "plans",
"anticipates", "believes", "estimated", "predicts", "potential", "continue",
"intends", "could", or the negative of such terms or other comparable
terminology. We made a number of assumptions in the preparation of these
forward-looking statements, including assumptions about the nature, size, and
accessibility of the market for Celacade in the treatment of chronic heart
failure, particularly in Europe, the regulatory approval process leading to
commercialization and the availability of capital on acceptable terms to
pursue the development of Celacade, and the feasibility of additional trials.
You should not place undue reliance on our forward-looking statements which
are subject to a multitude of risks and uncertainties that could cause actual
results, future circumstances or events to differ materially from those
projected. These risks include, but are not limited to, the outcome of further
ongoing analysis of the ACCLAIM trial results, the requirement or election to
conduct additional clinical trials and the size and design of any such trials,
delays or setbacks in the regulatory approval process, difficulties in the
maintenance of existing regulatory approvals, securing and maintaining
corporate alliances, the need for additional capital and the effect of capital
market conditions and other factors on capital availability, the potential
dilutive effects of any financing, risks associated with the outcomes of our
preclinical and clinical research and development programs, the adequacy,
timing, and results of our clinical trials, competition, market acceptance of
our products, the availability of government and insurance reimbursements for
our products, the strength of intellectual property, reliance on partners,
subcontractors, and key personnel, losses due to fluctuations in the
U.S.-Canadian exchange rate, and other risks detailed from time to time in our
public disclosure documents or other filings with the Canadian and U.S.
securities commissions or other securities regulatory bodies. Additional risks
and uncertainties relating to our Company and our business can be found in the
"Risk Factors" section of our Annual Information Form and Form 20-F for the
year ended November 30, 2007, as well as in our later public filings. The
forward-looking statements are made as of the date hereof, and we disclaim any
intention and have no obligation or responsibility, except as required by law,
to update or revise any forward-looking statements, whether as a result of new
information, future events or otherwise.

    %SEDAR: 00001047E          %CIK: 0001042018

For further information:

For further information: Glenn Neumann, Investor Relations, 2505
Meadowvale Blvd., Mississauga, ON, Canada, L5N 5S2, tel: (905) 817-2004, fax:
(905) 569-9231,

Organization Profile


More on this organization

Custom Packages

Browse our custom packages or build your own to meet your unique communications needs.

Start today.

CNW Membership

Fill out a CNW membership form or contact us at 1 (877) 269-7890

Learn about CNW services

Request more information about CNW products and services or call us at 1 (877) 269-7890