MISSISSAUGA, ON, Jan. 18 /CNW/ - Vasogen Inc. (NASDAQ: VSGN; TSX:VAS)
today announced that The Lancet, a world-leading medical journal, will publish
an article entitled 'Results of a non-specific immunomodulation therapy in
chronic heart failure (ACCLAIM trial): a placebo-controlled randomised trial'
in its January 19th issue (Lancet 2008; 371: 228-36). The article describes
the results from Vasogen's 2,400-patient ACCLAIM trial of its Celacade(TM)
system in patients with chronic heart failure. Celacade is designed to target
the destructive chronic inflammation underlying the development and
progression of chronic heart failure.
The interpretation of the findings in The Lancet is that: "Non-specific
immunomodulation (Celacade) may have a role as a potential treatment for a
large segment of the heart failure population, which includes patients without
a history of myocardial infarction (irrespective of their functional NYHA
class) and patients within NYHA class II."
While the ACCLAIM study did not meet its primary endpoint for the
intent-to treat-population, this primary endpoint was met for two large
pre-specified subgroups of patients. In the trial, Celacade was shown to
significantly reduce the risk of death or cardiovascular hospitalization by
39% in the subgroup of 689 patients with NYHA Class II heart failure, and by
26% in the subgroup of 919 patients with no prior history of heart attack.
Importantly, the large risk reduction observed in these subgroups was achieved
on top of the benefits derived from current standard-of-care medications and
device therapy for heart failure.
"We are extremely pleased with the publication of the ACCLAIM results in
The Lancet," commented Chris Waddick, President and 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
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.
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, 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.
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For further information:
For further information: Glenn Neumann, Investor Relations, 2505
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