Alle Storys
Keine Story von Vasogen Inc. mehr verpassen.

Vasogen Inc.

The Lancet Publishes Vasogen's ACCLAIM Results

Mississauga, Canada (ots/PRNewswire)

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(equal sign)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


For further information: Glenn Neumann, Investor Relations, 2505
Meadowvale Blvd., Mississauga, ON, Canada, L5N 5S2, tel:
+1-905-817-2004, fax: +1-905-569-9231,; For
Media: Dan Budwick, BMC Communications, Ph: +1-212-477-9007 x14,

Weitere Storys: Vasogen Inc.
Weitere Storys: Vasogen Inc.