Vasogen Reports on Outcome of FDA Meeting



    MISSISSAUGA, ON, June 27 /CNW/ - Vasogen Inc. (NASDAQ:  VSGN; TSX:VAS), a
biotechnology company focused on the research and commercial development of
technologies targeting the chronic inflammation underlying cardiovascular and
neurological disease, is pleased to announce the outcome of its meeting with
the Food and Drug Administration (FDA) regarding the next steps in the
development of its Celacade(TM) technology for the treatment of chronic heart
failure in the United States. During the meeting, the Company discussed with
the FDA the results of its ACCLAIM study, with a particular focus on the 
689-patient subgroup with NYHA Class II heart failure. As a result of the
meeting, the FDA has strongly recommended that Vasogen conduct a confirmatory
study to support a Pre-market Approval (PMA) filing and also recommended that
the Company consider utilizing a Bayesian statistical approach to designing a
confirmatory trial. The Bayesian approach involves a specific trial
methodology that allows utilization of prior trial results with a confirmatory
study to obtain additional information regarding efficacy and safety and has
the potential to substantially reduce the number of patients required for a
confirmatory study, as well as the cost and duration.
    "We are very pleased with the FDA's position regarding the ACCLAIM
results of Celacade in NYHA Class II heart failure patients and also that the
agency is encouraging us to work with them to develop a protocol for a
confirmatory study to support a PMA in the United States," commented Chris
Waddick, President and CEO of Vasogen. "Having received input from the FDA, we
are in a position to fully evaluate our options with respect to a confirmatory
trial that could potentially be smaller than the 689-patient NYHA Class II
subgroup of patients in ACCLAIM. We are continuing our ongoing dialogue with
the FDA, as well as consulting our statistical experts and other advisors to
review trial design options, and I look forward to providing an update on this
process on our upcoming second quarter conference call."
    The previously reported 2,408-patient, double-blind, placebo-controlled
phase III ACCLAIM trial of Celacade in patients with chronic heart failure was
completed in 2006. This important study involved 175 clinical centers in seven
countries and was designed to assess the ability of Vasogen's Celacade
technology to reduce the risk of death or first cardiovascular
hospitalization. The primary endpoint for the intent-to-treat study population
was not statistically significant (p=0.22); however, the risk reduction
directionally favored the Celacade group (hazard ratio=0.92). The key finding
from ACCLAIM was in a subgroup of 689 patients who had NYHA Class II heart
failure at baseline. In this large subgroup of patients, Celacade was shown to
reduce the risk of death or first cardiovascular hospitalization (the primary
endpoint for the trial) by 39% (n=689 patients, 216 events, p=0.0003).
Celacade was also shown to significantly reduce the risk of death or first
cardiovascular hospitalization by 26% in a subgroup of patients in NYHA
Classes II - IV with no prior history of heart attack (n=919 patients, 243
events, p=0.02). The ACCLAIM trial also demonstrated that Celacade resulted in
a significant improvement in quality of life (as measured by the Minnesota
Living with Heart Failure Questionnaire) for the entire study population
(n=2,408 patients, p=0.04). Consistent with earlier studies, Celacade was
shown to be well tolerated in the ACCLAIM patient population; there were no
significant between-group differences for any serious adverse events.
    According to the Heart Failure Society of America, heart failure is the
only major cardiovascular disease with prevalence and incidence on the rise.
Heart failure, which is now often referred to as an epidemic, is estimated to
affect 12 million individuals in North America and Europe, with an estimated
4.4 million having NYHA Class II stage disease. The financial burden of heart
failure on the healthcare system in the United States alone is estimated to
exceed $30 billion per year.

    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)
technology, is designed to activate the immune response to apoptosis - an
important physiological process that regulates inflammation. Celacade(TM) is
in late-stage development for the treatment of chronic heart failure and has
received European regulatory approval under the CE Mark for this indication.
Vasogen is also developing a new class of drugs for the treatment of certain
neuro-inflammatory disorders and is preparing to advance VP025, the lead drug
candidate from this new class, into phase II development.

    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, summary statements relating to
results of the ACCLAIM trial in patients with chronic heart failure, plans to
advance the development of Celacade(TM), plans to fund our current activities,
statements concerning our partnering activities and health regulatory
submissions, strategy, future operations, future financial position, future
revenues, projected costs, prospects, plans and objectives of management. 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 in the forward-looking
statements. These risks include, but are not limited to, the outcome of
further analysis of the ACCLAIM trial results, the requirement or election to
conduct additional clinical trials, delays or setbacks in the regulatory
approval process, 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, 2006, 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. Unless otherwise indicated, numerical values indicating
the statistical significance ("p-values") of results included in this document
are based on analyses that do not account for endpoint multiplicity.

    %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, www.vasogen.com, investor@vasogen.com

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