highly purified recombinant urate oxidase

Description

&#****8;Recombinant urate-oxidase (rUOX) produced in E.Coli is a tetrameric protein with identical subunits of a molecular mass of about *4 kDa. The cDNA coding for urate-oxidase was cloned from a strain of Aspergillus flavus . The monomer, made up of a single **2 amino acid polypeptide chain, has no intra- or inter-disulfide bridges. The drug product is a sterile, white to off-white, lyophilized powder intended for intravenous administration following reconstitution and is supplied in *-mL colorless, glass vials containing 1.5 mg recombinant urate-oxidae, 5.0 mg sucrose, *5.0 mg L-glycine, 1.0mg Tween**0 and between *2.6 and *4.3 mg of dibasic sodium phosphate. &#****8;&#****8;Urate oxidase (uricase EC 1.7.3 .3) is an enzyme of the purine breakdown pathway that catalyses the oxidation of uric acid to allantoin. It is present in many different organisms, but not in higher primates including human. Hyperuricaemia is most commonly associated with gout and also occurs in patients with malignancy, especially those with lymphoid malignancies due to rapid cell turnover and an increased rate of purine metabolism. &#****8;&#****8;Urate oxidase degrades uric acid to allantoin, which is 5 to *0 fold more soluble than uric acid. The drug is effective in the prevention and treatment of hyperuricaemia in patients with malignancy and in those who have undergone transplantation. It appears to act rapidly, safely and induces a more dramatic decrease in plasma levels of uric acid. In addition to the advantages resulting from this improvement in uric acid control, the high quality and characterization result in an improved safety profle.