Patent ID: 6858206

Claim:
A method of treating a human disease caused all or in part by a deficiency in α-L-iduronidase, comprising the steps of: (a) administering a pharmaceutical composition comprising a pharmaceutically acceptable carrier and a human recombinant α-L-iduronidase of SEQ ID NO:2, or a biologically active fragment of SEQ ID NO:2 which possesses the same or similar biological activity to SEQ ID NO:2, wherein said human recombinant α-L-iduronidase of SEQ ID NO:2, or the biologically active fragment thereof has a purity of greater than 99%, to a human subject in need thereof; (b) optimizing said treatment by assessment of primary efficacy endpoints; (c) optimizing said treatment by assessment of secondary efficacy endpoints; (d) optimizing said treatment by assessment of tertiary efficacy endpoints; and (e) optimizing treatment by assessment of safety endpoints.