AIMSPRO, a new treatment for Amyotrophic Lateral Sclerosis (ALS) also known as Lou Gehrig's disease, has been granted orphan drug designation by the US Food and Drug Administration (FDA).
The innovative anti-inflammatory agent produced by UK-based Daval International was given orphan drug status to boost increased funding and research in this high potential treatment for this rare disease.
Approaches have been made to Daval to conduct an international, multi-centre, clinical trial to determine whether ALS patients can be seen to benefit from the medication under double-blind conditions.
The treatment is derived from hyperimmune caprine serum and is currently under Phase II trialling in Europe for Scleroderma and for bladder dysfunction in Secondary Progressive Multiple Sclerosis. Both trials are expected to report in early 2010.
AIMSPRO has already achieved TGA Orphan Status in Australia for the treatment of both ALS and Krabbe Leukodystrophy (Krabbe's disease).