Vasogen Provides an Update on ACCLAIM-II Preparations



    MISSISSAUGA, ON, Dec. 17 /CNW/ - Vasogen Inc. (NASDAQ:  VSGN; TSX:VAS)
today provided an update on ACCLAIM-II, a confirmatory clinical trial which is
designed to support an application for US market approval of the Celacade(TM)
System for the treatment of patients with NYHA Class II heart failure.
    The Company has been working diligently on the ACCLAIM-II study,
including the establishment of a Steering Committee led by James B. Young, MD,
Chairman, Division of Medicine at the Cleveland Clinic Foundation and Medical
Director, Kaufman Center for Heart Failure; appointing Chairs for the Data and
Safety Monitoring Board (DSMB) and Central Endpoint Committee (CEC);
developing the study protocol, CEC adjudication plans, and other key trial
documents, such as case report forms and informed consent forms; and selecting
a contract research organization to assist with study execution.
    Concurrent with the preparations for ACCLAIM-II, Vasogen has been working
closely with the U.S. Food and Drug Administration (FDA) to finalize the
protocol and the statistical analysis plan for the study using a Bayesian
approach and adaptive clinical design. The planned study design indicates that
as few as 300 patients could provide sufficient data to confirm the finding in
the pre-specified sub-group of ACCLAIM patients with NYHA Class II heart
failure. 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. The ACCLAIM trial demonstrated a 39%
reduction (p=0.0003) in the risk of death and cardiovascular hospitalizations
for the large pre-specified subgroup of 689 NYHA class II heart failure
patients.
    In preparation for ACCLAIM-II, the FDA has been reviewing Celacade in the
context of their newly issued draft document entitled 'Guidance for Industry
Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products
(HCT/Ps) - Small Entity Compliance Guide' to assess whether this draft
guidance is relevant to the Celacade technology. To date, the Celacade System
has been regulated as a medical device with the Center for Devices and
Radiological Health (CDRH) acting as lead reviewer with input from Center for
Biologics Evaluation and Research (CBER). The FDA has recently informed the
Company that they expect Celacade to remain regulated as a medical device;
however, CBER may take the role of lead reviewer with CDRH providing input.
    "We expect FDA clarification shortly and are looking forward to our
formal agreement meeting with the agency. We are very pleased with the
progress we have made in preparation of this important study and look forward
to recruiting the first patient into ACCLAIM-II," commented Chris Waddick,
President and CEO of Vasogen. "With today's announcement of the initial orders
for Celacade in Europe, where Celacade is already approved, and the planned
initiation of ACCLAIM-II, 2008 promises to be an exciting time for Vasogen."

    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 System,
is designed to activate the immune response to apoptosis - an important
physiological process that regulates inflammation. Celacade 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. VP025 is the lead drug candidate from this new
class.

    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, 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.

    %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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