Following the provision of clinical and scientific data to the US Food and Drug Administration (FDA), privately owned UK company Daval International Limited (http://www.davalinternational.com) has been informed that its innovative anti-inflammatory agent AIMSPRO(R) has been awarded an Orphan-Drug designation for the treatment of Amyotrophic Lateral Sclerosis (ALS).
ALS, also known as Lou Gehrig's disease, is the most common form of Motor Neurone Disease. 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 sourced and manufactured in Australia with a TGA export listing. It 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.
The veterinary form of the product, Ceremben(R) 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.