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Daval International Awarded Orphan Drug Designation for Motor Neurone Disease Treatment

November 9, 2009

LONDON, November 9 /PRNewswire/ — 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.

SOURCE Daval International Ltd


Source: newswire



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