The Lancet Publishes Vasogen's ACCLAIM Results
18 Janeiro 2008 - 9:00AM
PR Newswire (US)
MISSISSAUGA, ON, Jan. 18 /PRNewswire-FirstCall/ -- 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 study. 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. 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,
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. DATASOURCE: Vasogen Inc. CONTACT: Glenn Neumann,
Investor Relations, 2505 Meadowvale Blvd., Mississauga, ON, Canada,
L5N 5S2, tel: (905) 817-2004, fax: (905) 569-9231,
http://www.vasogen.com/, ; For Media: Dan Budwick, BMC
Communications, Ph: (212) 477-9007 x14,
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