Vasogen Plans Confirmatory Study of Celacade(TM) in Chronic Heart Failure to Support U.S. Regulatory Approval



    MISSISSAUGA, ON, Sept. 17 /CNW/ - Vasogen Inc. (NASDAQ:  VSGN; TSX:VAS),
today announced plans for a confirmatory study that would support an
application for regulatory approval in the United States of its Celacade
technology for the treatment of patients with NYHA Class II heart failure. The
planned trial design indicates that as few as 300 patients could provide
sufficient data to confirm the finding of the phase III ACCLAIM trial which
demonstrated a 39% reduction (p equals 0.0003) in the risk of death or
cardiovascular hospitalizations for the large pre-specified subgroup of 689
NYHA class II heart failure patients.
    "We are extremely pleased with the proposed design for a confirmatory
trial of Celacade in patients diagnosed with NYHA Class II heart failure. For
the purpose of obtaining U.S. regulatory approval, an adaptive trial design
utilizing a Bayesian statistical approach provides us with the possibility of
confirming our earlier results with as few as 300 patients," commented Chris
Waddick, President and CEO of Vasogen. "We are now preparing to meet with the
FDA, with the objective of obtaining formal FDA agreement with respect to our
proposed trial design prior to the end of the year. Furthermore, we continue
to be on track for the initial commercialization of Celacade by year-end in
the European Union, where Celacade has already received CE Mark regulatory
approval for the treatment of NYHA Class II heart failure."
    In May, Vasogen met with the FDA to review the ACCLAIM trial data, which
demonstrated a 39% reduction (p equals 0.0003) in the risk of death and
cardiovascular hospitalizations for the large pre-specified subgroup of 689
NYHA class II heart failure patients. As a result of the meeting, the FDA
strongly recommended that Vasogen conduct a confirmatory study to support a
U.S. Pre-Market Approval filing for Celacade for NYHA Class II heart failure
patients and also recommended that the Company consider utilizing a Bayesian
approach. This approach involves a trial design methodology that allows
utilization of prior trial results to contribute to the statistical power of a
confirmatory study and therefore provides the opportunity to significantly
reduce the number of required patients, as well as the cost and duration of
the study. As a result of the FDA's recommendations, Vasogen retained Berry
Consultants and 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, to assist with the development of a confirmatory study.
The proposed trial design indicates that as few as 300 patients could provide
sufficient data to confirm the finding of the ACCLAIM trial. 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.
    As in Vasogen's ACCLAIM study, it is expected that the primary endpoint
of the planned study will be death or first cardiovascular hospitalization.
The double-blind, placebo-controlled study is also expected to have similar
inclusion/exclusion criteria as ACCLAIM, with all patients on standard-of-care
medication for heart failure. If successful, this trial is expected to support
an application for regulatory approval in the United States of Vasogen's
Celacade technology for the treatment of patients with NYHA Class II heart
failure. The final study design and sample size are subject to approval by the
FDA. The Company is in the process of establishing a Steering Committee that
will provide input to the final study design, which will then be subject to
approval by the FDA.
    Heart failure, most frequently resulting from coronary artery disease or
hypertension, is a debilitating syndrome in which the heart's ability to
function as a pump is impaired. Patients with heart failure experience a
continuing decline in their health, resulting in an increased frequency of
hospitalization and premature death. 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, and an estimated 4.4 million have NYHA Class II
symptomatic impairment.

    About Celacade:

    Therapy utilizing the Celacade technology targets the inflammation
underlying chronic heart failure and other cardiovascular diseases.
Inflammation is a normal response of the immune system to cellular injury
caused by infection, trauma, or other stimuli. During the inflammatory
process, immune cells release a number of factors, including cytokines -
potent chemical messengers that modulate inflammation and facilitate the
healing process. While this inflammatory process is usually self-limiting, it
can persist, become chronic, and lead to a number of serious medical
conditions.
    During a brief outpatient procedure, a small sample of a patient's blood
is drawn into Vasogen's Celacade single-use disposable cartridge and exposed
to controlled oxidative stress utilizing Vasogen's proprietary Celacade
medical device technology. Oxidative stress is a factor known to initiate
apoptosis, a physiologic process that is inherently anti-inflammatory. The
treated blood is then administered to the same patient intramuscularly. An
initial course of treatment comprising three consecutive outpatient procedures
is administered over a two-week period, and treatments are continued once per
month thereafter.

    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 ongoing analysis of the ACCLAIM trial results, the requirement or
election to conduct additional clinical trials and the size and design of any
such trails, 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. 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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