Amikacin liposome Infectious disease An agent in clinical trials for treating complicated UTIs, acute infections in cystic fibrosis, nosocomial pneumonia
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Preliminary Phase II data presented today show patients who received a one-day, single dose regimen with MiKasome (liposomal amikacin), produced by NeXstar Pharmaceuticals Inc.
The study, conducted at seven centers in the United States and Canada, was designed to evaluate the safety and preliminary efficacy of MiKasome at four separate doses and dose schedules: 10 mg/kg daily for seven days, a single dose of 40 mg/kg, a single dose of 2 grams, and a single dose of 3 grams.
Nasdaq/NMS:NXTR) today announced that new Phase II data for its proprietary investigational antibiotic MiKasome (liposomal amikacin) has been accepted for presentation on Monday, March 22, 1999, at the 9th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), in Berlin, Germany.
Designed to evaluate the safety and preliminary efficacy of MiKasome at various doses and dose schedules, the study was conducted at seven medical sites in the United States and Canada.
Highlights of early-stage animal studies conducted by NeXstar Pharmaceuticals indicate that MiKasome demonstrated the following properties:
This has been a remarkable meeting for us, but it is important to note that while these results are not indicative of similar activity in humans, we have planned additional studies to help determine the effectiveness and overall safety of MiKasome in the treatment of patients for a wide range of severe bacterial infections," said Sandy Sandhaus, M.
The company said this increase was due to expanded clinical trial activity for both DaunoXome (daunorubicin citrate liposome injection) and MiKasome (amikacin liposome injection); for additional pre-clinical spending on aptamer drug candidates from the SELEX process, the company's proprietary combinatorial chemistry technology; and the above-mentioned AmBisome development expenses.
Based on our extensive preclinical data and our initial phase I results that to date confirm our preclinical findings, we believe that MiKasome will become a very important drug to the company.
30, 1996--In two presentations made this week, NeXstar Pharmaceuticals (NXTR:NASDAQ) revealed some of the preclinical data included in the Company's recent Investigational New Drug (IND) application for MiKasome.
Food and Drug Administration (FDA) for clinical testing of MiKasome in patients with a variety of serious bacterial and mycobacterial infections.
Other liposomal products in development include MiKasome, a liposomal antibiotic, and VincaXome, a liposomal anti-cancer agent.
NASDAQ:NXTR) announced today that it has acquired patent rights for MiKasome, the Company's liposomal formulation of the antibiotic amikacin, by assignment from AmpliMed Corporation, a privately held company in Tucson, Arizona.