In the clinical phase I trial AFF001,
AFFiRiS GmbH has now recruited the 24 Alzheimer patients planned for this
trial. The trial aims to investigate the tolerability and safety of an
innovative Alzheimer's vaccine (AFFITOPE AD01). In the trial, all patients
have now been vaccinated at least once and have so far tolerated the
vaccine
extremely well. The treatment provides for four vaccinations administered
at
monthly intervals and is due to be fully completed by this October. The
vaccine's tolerability can then be conclusively evaluated. So far the
results indicate good tolerability for this Alzheimer's vaccine from
AFFiRiS
GmbH. It is on this basis that recruitment of further patients has already
begun for the clinical trial of a second Alzheimer's vaccine by AFFiRiS.
Vienna-based AFFiRiS GmbH has announced the successful completion of
patient
recruitment for clinical phase I testing of its Alzheimer's vaccine AD01.
The vaccine is being administered at the Vienna General Hospital (AKH) to
24
Alzheimer's patients at a mild to moderate stage of the disease. The
patients are being vaccinated a total of four times over a three-month
period. During this time, and over a further two months, the safety and
tolerability of the vaccine is being investigated. A professional care
network with the highest medical standards ensures the patients' health
and
well-being.
Commenting on the planned progression of the trial, Dr. Walter Schmidt,
CEO
of AFFiRiS GmbH says: "We have now treated the maximum number of patients
for the first time. After the end of the trial in a few months' time, we
will know whether the impression so far of our vaccine's good tolerability
is confirmed. As patient interest in the last few months has grown
significantly, we are delighted that we are already in a position to offer
participation in clinical testing of our second Alzheimer's vaccine,
AFFITOPE AD02. The support from our largest investor, MIG-Fonds, is
crucial
in this regard, as only sound financing enables this rapid progression in
clinical studies."
The Alzheimer's vaccines developed by AFFiRiS are based on AFFITOME
technology developed in-house, which functions using the mimotope
principle.
This technology enables the development of customized vaccines known as
AFFITOPE. Dr. Schmidt explains the special features of AFFiRiS's approach
to
the Alzheimer's vaccine: "Alzheimer's is caused by beta-amyloid, an
unwanted
fragment of one of the body's own proteins that occurs on the surface of
brain cells. Development of a successful vaccine is extremely challenging
as
it is vital to ensure that antibodies only attack beta-amyloid if it
occurs
separated in the brain fluid but not as long as it is still part of the
normal APP protein on the brain cells. The brain cells would otherwise be
attacked. Thanks to AFFITOME technology, we are in the unique position of
being able to safely protect the brain cells and only combat the
disease-causing beta-amyloid."
AFFITOME technology patented by the company enables scientists to create
both molecules with very specific binding characteristics and molecules
that
differ in structure but exhibit identical binding characteristics. These
strengths are now being used in developing the AD01 and AD02 vaccines,
both
of which align the immune system against the same beta-amyloid structure.
However, AFFITOME technology can also be used to have a positive influence
on other human rogue proteins - such as lipid metabolism enzymes.
Consequently, an appropriate development by AFFiRiS could provide an
effective treatment for atherosclerosis.
Michael Motschmann, Senior Fund Manager at MIG-Fonds, explains his views
on
this development by AFFiRiS GmbH: "The company 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 disease that AFFiRiS has chosen to tackle is
atherosclerosis, where a tailor-made vaccine is also under development.
The
company's development pipeline is already full, with the business model ¬
which we support in full - envisaging a new product entering clinical
testing every two years."
About AFFiRiS GmbH (as at July 2008)
AFFiRiS GmbH develops peptide-based vaccines for the treatment of
Alzheimer's disease, atherosclerosis and other diseases that urgently
require a medical solution. The company has established platform
technologies and registered the corresponding patent families. The first
patents have already been issued. The company employs 35 highly qualified
members of staff on 600 sqm of rented laboratory facilities at the Campus
Vienna Biocenter .
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. Its innovative, high-potential products and the
entrepreneurial skills of its 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.
AFFiRiS GmbH