AIMSPRO is Awarded TGA Orphan Status for the Treatment of Amyotrophic Lateral Sclerosis

June 1, 2009

LONDON, June 1 /PRNewswire/ — 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.


SOURCE Daval International Ltd

Source: newswire

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