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Phase III Trial Results Show Elitek(R) (rasburicase) Significantly Reduced Plasma Uric Acid Levels versus Allopurinol in Adults with Hematologic Cancers at Risk for Tumor Lysis Syndrome
Date:12/6/2008

- Results Presented at ASH Annual Meeting-

SAN FRANCISCO, Dec. 6 /PRNewswire-FirstCall/ -- Sanofi-aventis today announced results of a randomized phase III study presented at the 50th Annual Meeting of the American Society of Hematology. The study in adult patients with hematological malignancies at high or potential risk for tumor lysis syndrome (TLS) demonstrated that Elitek(R) (rasburicase) significantly reduced plasma uric acid (PUA) levels compared to allopurinol alone (p=0.0012). The study also compared a sequential combination of the two agents (Elitek for three days followed by allopurinol for three days, with one day overlap) versus allopurinol alone, which showed a reduction in plasma uric acid levels for the sequential combination versus allopurinol alone (p=0.06).

Tumor lysis syndrome is a potentially life-threatening metabolic complication that can result either spontaneously or following treatment of certain types of rapid-growing cancers, particularly leukemia or lymphoma. The syndrome develops when a particularly large volume of cells associated with fast growing tumors are destroyed, releasing cellular by-products into the blood system such as uric acid, faster than can be eliminated. Elevated levels of plasma uric acid can cause hyperuricemia, a serious condition that can lead to renal failure if not controlled.

The primary objective of the multi-center, open-label, randomized, parallel group comparative study was to compare the adequacy of control of PUA concentration and the safety profile in three treatment arms. Among the three treatment arms, plasma uric acid response rate (defined as normalization or maintenance of PUA levels less than or equal to 7.5mg/dl at days 3-7) was 87% of patients treated with Elitek compared to 66% receiving allopurinol alone (p=0.001) and 78% with Elitek/allopurinol (p=0.06). Among patients at high risk for tumor lysis syndrome, the PUA response ra
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