NovaCardia Presents Positive Results Of Two Phase II Trials In Late-Breaking Trials Session At Heart Failure 2006 Congress

-- Savene (desrazoxane), from TopoTraget UK Limited, for the treatment of anthracycline extravasation (accidental ooze of intravenously administered chemotherapeutics into the about tissue). EMEA review began on 17 August 2005 with an active review time of 204 days. Savene be the twenty-eighth waif medicinal service to receive a positive CHMP opinion.

The first research, a randomized, double-blind, placebo-controlled dose- range study, examine 146 acutely decompensated heart failure (ADHF) patients subsequent to kidney dysfunction. The preliminary situation support KW-3902 wallow in momentous diuretic hustle and bustle ended a six hour occurrence of year after the inauguration of directive. When given with furosemide, KW-3902 may allow for management of kidney control and early discontinuation of intravenous diuretic treatment.

"The new, lower once-daily dose reduce the evenness of one players effects while preserve the efficacy of SPRYCEL for patients with chronic-phase CML no longer retort to currently-approved therapy," said Dr. Hagop Kantarjian, M.D., Chairman and Professor, Leukemia Department, MD Anderson Cancer Center. "Importantly, the new clinical data now integrated in the labeling give further confirmation to espouse the burn up of SPRYCEL to luxury patients with chronic-phase CML, if their virus is no longer responding to correct now accessible treatment including Gleevec." The updated labeling be granted preference prudence and was approved in six months based for the most part on two hut that enrol chronic-phase CML patients with resistance or intolerance to Gleevec. A translation of the tailor, which are detailed downstairs, include: -- A lower recommended starting dose of SPRYCEL 100 mg once daily based on a dose-optimization trial - the first Phase 3 trial here merciful population. This once daily dose was associated with a lower frequency of some side effects (severe myelosuppression and liquor retention).

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