Well, today we have unexpected bad news for NXTR's AmBisome and good news for GILD's Proveon.
However, the MiKasome abstract from Berlin conference show where is NXTR strain and management weakens (in pass)!
Miljenko
P0194 UTI Treatment using liposomal amikacin (MiKasome)
Dr. John Krieger
Seattle, USA
New Drugs
Poster Session Hall 17
March 22, 1999
09.00-17.00
Introduction: MiKasome, a small unilamellar liposome-encapsulated amikacin, is designed to reduce aminoglycoside renal toxicity and ototoxicity and has a circulating half-life of approximately 1 week following intravenous infusion in humans.
Objectives: To evaluate the safety and preliminary efficacy of four MiKasome dosage regimens for treating adults with complicated UTI.
Methods: Four groups of patients are to receive MiKasome using an open-label, sequential design. Preliminary results are available for the first two groups: patients received either seven daily infusions of MiKasome at 10 mg/kg (group I, n=13 evaluable) or a single 40 mg/kg infusion (group II, n=22 evaluable). Bacteriologic and clinical cure were determined at 14 and 36 days from the start of therapy. Two fixed, single-dose groups, at 2 and 3 g, are still enrolling.
Results: In group I, bacteriologic cure rates were 62 nd 77 and in group II they were 82 nd 92 The clinical cure rates were 92 nd 86 n group I, and 92 nd 86 n group II (days 14 and 36, respectively, in each pair). Among all patients with a bacteriologic response at day 14, there was one recurrence at day 36 (1 of 26). No clinically significant safety issues have been seen.
Conclusions: MiKasome appears to be safe and effective in treating patients with complicated UTI. A single infusion of 40 mg/kg appears to be as effective as seven daily infusions of 10 mg/kg.
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