Aimspro Is Awarded Tga Orphan Status For The Treatment Of Amyotrophic Lateral Sclerosis

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1st June 2009, 10:40pm - Views: 578

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


LONDON, June 1 /PRNewswire-AsiaNet/ --

    Privately owned UK biotech company Daval International Limited

( 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

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