LONDON — Privately owned UK biotech company Daval International Limited (http://www.davalinternational.com) has been informed by Australia’s Therapeutic Goods Administration (TGA) that its innovative anti-inflammatory agent AIMSPRO(R) has been awarded Orphan Status for the treatment of Amyotrophic Lateral Sclerosis (ALS).
ALS is the most common form of Motor Neuron Disease (MND), also known as Lou Gehrig’s disease. AIMSPRO has already achieved TGA Orphan Status for the treatment of Krabbe Leukodystrophy (Krabbe’s disease). Daval is now evaluating an international, multi-centre, placebo controlled, Randomised Clinical Trial to determine whether later stage ALS patients with poor respiratory function 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. It is derived from hyperimmune caprine serum and is currently under Phase II trialling in Europe for advanced Scleroderma and for bladder dysfunction in Secondary Progressive Multiple Sclerosis. Both trials are expected to report in the first quarter of 2010. Additional open label experience with AIMSPRO, over an extended period, has led Daval to consider Proof of Concept studies in Adhesive Arachnoiditis, treatment resistant Myasthenia Gravis and Psoriatic arthritis.
AIMSPRO is listed on the Export Only section of the Australian Therapeutic Goods Registry and is imported into Europe by Biotec Distribution (Wales) Limited for clinical trial and “named patient use” purposes.
The veterinary form of the product, Ceremben(R) has shown efficacy, safety and tolerability in studies addressing critically important indications in standardbred and thoroughbred horses. The Australian regulator, the APVMA, has recently awarded Ceremben a Research Permit, which will enable confirmatory equine field trials to be rapidly completed. Ceremben is also being developed as a potential canine and feline anti-inflammatory agent.