LONDON, June 1 /CNW/ - 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.
For further information:
For further information: Brian Quick, firstname.lastname@example.org,