2nd Alzheimer¹s vaccine by AFFiRiS
AFFIRIS DEVELOPS ALZHEIMER'S VACCINE
VIENNA, 17. April 2008. The Viennese biotech company Affiris is
today taking stock of the progress achieved to date in its clinical
Alzheimer's vaccination programme. All the Alzheimer's patients
treated so far as part of the toxicological trials have tolerated
the treatment extremely well. As a result, Affiris is among the
leading international centres in the race to develop the first
causal immunotherapy for Alzheimer's disease.
Due to the dramatic increase in the number of Alzheimer's cases,
new and more effective treatments are urgently needed. The
medicines that are currently in use are of limited value as they
can only alleviate the symptoms of the disease temporarily, for a
period of around one to two years, and are ultimately unable to
prevent the onset of dementia. However, the Viennese biotech
company Affiris is pursuing a new approach, which is yielding
extremely promising results. The company is using an innovative
Alzheimer¹s vaccine not just to target the symptoms of the
disease, but in the hope of directly modifying the disease
process in the brain of Alzheimer's patients.
SAFETY IS THE NUMBER ONE PRIORITY
Safety is the number one priority in the current clinical trials
that are being carried out on patients. "The current studies are
focused on establishing the safety and tolerability of
the new vaccines," emphasises Prof. Achim Schneeberger, Head of
Clinical Department at Affiris. The new vaccines are currently
being tested in two Alzheimer's trials. The AFFiRiS001 trial is
being staged at the Vienna General Hospital (AKH) and is testing
the vaccine AFFITOP AD01. The AFFiRiS 002 trial of the vaccine AD02
is being conducted at the Institute of Psychosomatic Medicine,
Vienna.
Although the two vaccines have different active ingredients
the antigenic peptide both trials are virtually identical in
terms of their design.
Interim toxicity findings from the AFFiRiS 001 trial, which began
in September 2007 and involves to date 9 Alzheimer¹s patients
with mild to moderate dementia, indicate that the innovative
immunotherapy is safe. Prof. Schneeberger explains: "All the
patients have thus far tolerated the vaccines extremely well, as
expected." The AFFiRiS 002 sister trial also got off to a similarly
promising start at the end of February 2008 - all of the
Alzheimer¹s patients that have been involved in the trial have
also received and tolerated their first vaccinations.
PROTEIN DEPOSITS IN THE BRAIN
The Aß amyloid is the main component in the protein deposits
(amyloid plaques) that are characteristic of Alzheimer's dementia.
The accumulation of this amyloid in the form of neurotoxic
aggregates destroys brain cells and causes the typical symptoms of
Alzheimer's disease. During the 2001 trial of a previous
Alzheimer's vaccine called AN1792, which was conducted by the U.S.
and Irish pharmaceutical alliance ELAN-Wyeth, patients suffered
severe inflammation of the brain and the trial was immediately
halted.
Despite this, follow-up analyses showed that the vaccine had been
effective in some of the patients. Around 20 percent of those who
received the vaccine developed antibodies that protected against
the Aß amyloid and disease progression was halted in a number
of the patients.
THE FASCINATING CONCEPT BEHIND THE ALZHEIMER'S VACCINE "Our
Vienna-based research group is in the process of modifying the
immunogen for the vaccine," explains Prof. Schneeberger. Scientists
at Affiris are also using an ingenious approach based on the
principle of molecular mimicry to exclude potential unwanted side
effects in advance.
This technology allows the intended immune reaction to be
accurately directed against harmful protein deposits. A
multifaceted approach to safety means that this "immunological
camouflage" is supported by a combination of additional safety
components developed by Affiris. These include the immunogenic
peptide, a carrier protein and a proven and safe adjuvant (vaccine
additive). The peptides in use are short mimotopes of the Aß
amyloid that are between six and seven amino acids long. While this
should permit the breakup of harmful proteins in the brain, it
should also prevent any undesired immune reactions. An animal model
used by Affiris for Alzheimer¹s dementia not only confirmed
that the vaccine can reduce amyloid plaques by around 70 percent,
but also showed that the animals performed significantly better in
brain function tests after treatment. The first clinical trials on
Alzheimer's patients have now also indicated that this concept
works extremely well. As all the patients treated so far have
tolerated the vaccine without any noteworthy complications, the way
is now open for the next stage of testing. This milestone also
means that the vaccine developed by Affiris is one of the best
hopes in the fight against Alzheimer's disease.
AFFIRIS - research for better health
Affiris is a young and innovative Vienna-based biotechnology
company which has been operating from Campus Vienna Biocenter since
2003 and employs more than 30 highly skilled staff. The company has
an international outlook and collaborates with partner centres in
Germany, Spain, the U.K. and the U.S.
"Our research work focuses on the development of treatments for
diseases that urgently require a medical solution. Alongside the
Alzheimer's programme, we at Affiris are also working to develop
and make available new medicines for the treatment of other major
diseases such as atherosclerosis in the near future," explains
scientist, founding member and CEO of Affiris GmbH, Dr. Walter
Schmidt.
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Posted: April 2008
