FDA Grants Orphan-Drug Designation To Aimspro

Daval International has received Orphan-Drug designation for its anti-inflammatory agent Aimspro for the treatment of amyotrophic lateral sclerosis (ALS) from the FDA.

The company said that Aimspro has already achieved TGA Orphan Status in Australia for the treatment of both ALS and Krabbe Leukodystrophy (Krabbe’s 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.

Aimspro is a new generation biological medicine which is derived from hyperimmune caprine serum and is currently under Phase II trialing in Europe for Scleroderma and for bladder dysfunction in secondary progressive multiple sclerosis. Both trials are expected to report in the first half of 2010.

Reportedly, the veterinary form of the product, Ceremben has shown efficacy, safety and tolerability in horses. The Australian regulator, the APVMA, has recently awarded Ceremben a permit enabling promotion and sales to veterinary surgeons for the treatment of equine endotoxemia.