ALS Treatment Awarded Orphan Drug Designation

Mon, 11/09/2009 - 3:52am
Following the provision of clinicaland scientific data to the US Food and Drug Administration (FDA), privatelyowned UK company Daval International Limited has been informed that its innovativeanti-inflammatory agent AIMSPRO(R) has been awarded an Orphan-Drugdesignation for the treatment of Amyotrophic Lateral Sclerosis (ALS).ALS, also known as Lou Gehrig's disease, is the most common form of MotorNeurone Disease. AIMSPRO has already achieved TGA Orphan Status in Australiafor 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 fromthe medication under double-blind conditions. AIMSPRO is a new generation biological medicine which is sourced andmanufactured in Australia with a TGA export listing. It is derived fromhyperimmune caprine serum and is currently under Phase II trialing in Europefor Scleroderma and for bladder dysfunction in Secondary Progressive MultipleSclerosis. 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, hasrecently awarded Ceremben a permit enabling promotion and sales to VeterinarySurgeons for the treatment of equine endotoxemia.

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