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Affiris Begins Clinical Testing Of Alzheimer's Vaccine
The Alzheimer's vaccine known as Affitope AD01
from
Affiris has now entered the clinical phase of its development. All
relevant
regulatory and statutory approvals have been secured and this innovative
treatment is now being tested on humans for the first time. This
development
means that the 8.5 million-Euro venture capital finance agreement the
company concluded with Munich-based MIG-Fonds in April 2006 has reached a
key milestone on schedule. Up to 24 Alzheimer's patients are to be
vaccinated, with the aim of this initial phase I trial being to
demonstrate
the vaccine's safety and its suitability for human use. The trial is being
run at the Vienna General Hospital and is due to be completed within one
year. If it can be successfully proven that the vaccine has a positive
safety and suitability profile, the second stage of the clinical
development
process could begin as early as next year. The aim of this stage in
clinical
testing would be to demonstrate the vaccine's efficacy, a goal that no
treatment anywhere in the world has yet achieved.
Affiris GmbH, based in Vienna, Austria, recently announced the start of the
first phase I clinical trial for its first Alzheimer's vaccine, Affitope
AD01. The vaccine is being administered at the Vienna General Hospital
(AKH)
to up to 24 patients who have reached the disease stage "mild to
moderate".
The patients will be vaccinated four times over a period of three months,
and the safety and suitability of the vaccine will be analysed over six
months. A closely meshed care network of the highest medical standards
will
ensure the patients receive the safest possible treatment.
Dr. Walter Schmidt, CEO of Affiris GmbH, comments on the start of the
clinical phase: "This, the most important chapter in our company history
so
far, is a fantastic development for both Alzheimer's sufferers and our
investors. Everyone at Affiris is thrilled. We are confident that the
start
of our clinical trials represents a major new step in the therapy of
Alzheimer's disease, an illness that still lacks a fundamentally effective
treatment. The need for such a treatment is particularly pressing given
the
enormous number of sufferers worldwide - over 12 million. However, this
need
is one that not even the "giants" of the pharmaceutical industry can
currently meet. Our investors, MIG-Fonds, are naturally also delighted
that
we have reached this important milestone on schedule."
Affiris has developed the Alzheimer's vaccine from patented Affitope
technology, which is based on mimotopes and allows customized vaccines to
be
manufactured cost-effectively. Dr. Schmidt explains the special features
of
Affiris' approach to the Alzheimer's vaccine: "Alzheimer's is caused by
beta-amyloid, an unintentionally formed fragment of one of the body's own
proteins that occurs on the surface of brain cells and has the scientific
abbreviation APP. In principle, it is extremely difficult to develop a
vaccine as it is vital to ensure that the immune system only reacts after
the beta-amyloid has separated into the brain fluid and not before, when
it
is present as a healthy component of the APP protein of brain cells.
Nobody
wants to provoke an immune response against the patient's brain cells. Our
approach protects the brain cells and only combats the disease-causing
beta-amyloid, irrespective of whether it is still present in its dissolved
form in the brain fluid, or has already formed plaque deposits."
Affiris specialises in the development of treatments for diseases that
urgently require a medical solution and also offer attractive market
potential. With 22 million sufferers predicted for 2025 and no effective
treatment, Alzheimer's is one such disease. The second major disease that
Affiris has chosen to tackle is hardening of the arteries, or
atherosclerosis. A customized vaccine is also being developed to treat
this
disease and is currently still at the pre-clinical stage of development.
The
company¹s development pipeline is already full, with Affiris' business
model
envisaging that a new product will enter clinical testing every two years.
About MIG-Fonds
The participation of MIG Verwaltungs AG in Affiris GmbH represents the
continuation of a tried-and-tested approach. Investment is only made in
selected companies in Germany and Austria after their viability has been
thoroughly audited. Their innovative, high-potential products and the
entrepreneurial skills of their management teams are both key. MIG
Verwaltungs AG is supported by Alfred Wieder AG. This specialist in
venture
capital is experienced in the sale of holdings and is therefore the first
point of contact for any potential investors.
About AFFiRiS GmbH
AFFiRiS GmbH develops peptide-based vaccines for the treatment of
Alzheimer's disease, atherosclerosis and other serious diseases. The
company
has established platform technologies and registered the corresponding
patent families. The first patents have already been issued. The company
employs 30 highly qualified members of staff on 600 sqm of rented
laboratory
facilities at the Campus Vienna Biocenter .
http://www.affiris.com
Affiris începe clinice de testare a Alzheimer's vaccin - Affiris Begins Clinical Testing Of Alzheimer's Vaccine - articole medicale engleza - startsanatate