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Robert M. Fielding, senior pharmacologist in NeXstar Pharmaceuticals' Life Sciences group, presented the data at the annual meeting of the American Association of Pharmaceutical Scientists (AAPS) in Seattle.
On Friday, The Company received word that the U.S. Food and Drug Administration had approved the Company's IND for MiKasome, the Company's proprietary liposomal formulation of amikacin. Amikacin belongs to a family of antibiotics known as aminoglycosides.
These antibiotics are toxic to a wide range of bacteria, but their usefulness is limited by less than optimal safety profile and short residence time in the body. The main treatment-limiting side effect of aminoglycosides is kidney toxicity, which is caused by the rapid clearance of these drugs from the bloodstream and through the kidney.
In the first presentation, on Monday, October 28, Fielding discussed preclinical studies demonstrating the ability of MiKasome administered into the lungs to prolong the time that amikacin remained in the lungs and airways. Forty-eight hours after MiKasome administration into the lungs, over half the antibiotic remained in the lungs. Levels of amikacin in the kidneys remained low throughout the measurement period.
MiKasome administered into the lungs may be useful in treating Pseudomonas pneumonia, tuberculosis, mycobacterium avium complex (MAC) - an infection that largely affects HIV-infected individuals - and the treatment resistant infections that accompany cystic fibrosis and chronic obstructive pulmonary disorder (COPD). In this experiment, administration of MiKasome into the lungs produced total amikacin concentrations almost five-fold higher than the observed effective concentration in vitro for Mycobacterium avium.
In the second presentation, made today, Fielding revealed the results of preclinical dosing studies showing that MiKasome administered into the blood stream produced 7-fold higher peak plasma concentrations of amikacin than when free drug was injected intravenously. Total area-under-the-curve levels - a measure of the total amount of drug that remains in circulation - were 150-fold higher with MiKasome than with free amikacin. A single dose of MiKasome also sustained potentially therapeutically useful amikacin levels for over 72 hours.
With conventional amikacin, over 90 percent of the drug passes through the kidneys within a few hours. With MiKasome injection, only six percent passed through the kidneys 24 hours after injection, and only 12 percent was cleared through the kidneys a week after injection.
"With this type of pharmacokinetic profile, we can envision some novel dosing regimens for MiKasome, such as injections twice weekly instead of daily," said Fielding. Phase I safety and pharmacokinetic studies, slated to begin shortly, will test this hypothesis in humans.
NeXstar Pharmaceuticals, Inc. is an integrated pharmaceutical company engaged in the discovery, development, manufacturing and marketing of products to treat life-threatening diseases, including cancer and infectious diseases. The Company currently markets two drugs, AmBisome and DaunoXome. The Company has headquarters in Boulder, Colorado; research, development and manufacturing facilities in San Dimas, California; Antwerp, Belgium; Lakewood, Colorado, and Boulder; and marketing subsidiaries worldwide.
Note for editors: This press release is available on our Web site at http://www.nexstar.com/Press_Releases/PR96.htm. After viewing the press release at this site you can save it as a text file for further use.
CONTACT: NeXstar Pharmaceuticals Inc., Boulder Joseph Alper, 303/546-7717 Katy Doherty, 303/546-7889 web site at http://www.nexstar.com
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