Breakthrough: Results
from the fourth year in a long-term clinical study prove the disease
modifying effect of GRAZAX(R). For the first time ever, it is documented
that the positive clinical effect of the tablet vaccine persists after
completion of treatment.
Today, ALK announces main results from the first follow-up year in a
long-term study (GT-08) with GRAZAX(R), the company's tablet-based vaccine
against grass pollen allergy. The clinical study documents that the effect
of GRAZAX(R) persists following completion of the recommended three-year
treatment regimen. Furthermore, blood samples from patients show a
persistent, positive effect on the immune system indicating a lasting
tolerance to grass pollen.
During the first year after completion of treatment, GRAZAX(R)
continues to provide statistically significant reductions in both hay fever
symptoms and the use of symptom-relieving medication.
In the follow-up year, hay fever symptoms were reduced by 31% while the
use of symptom-relieving medication was reduced by 52%. The reduction of
symptoms and use of medication is measured as median values relative to a
control group in which patients had unrestricted access to
symptom-relieving medication.
The patients in the study have adhered to the recommended three-year
GRAZAX(R) treatment regimen and completed treatment in the autumn of 2007.
The above-mentioned results cover the 2008 pollen season, the first season
in which the patients did not receive active treatment with GRAZAX(R).
The fourth-year results represent a major breakthrough, since ALK is
the first company ever to document a persistent disease modifying
vaccination effect of a tablet-based allergy vaccine. Patients cannot
obtain such a persistent vaccination effect with traditional
symptom-relieving allergy medication.
ALK-Abello A/S
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