i'm doing it at the university medical center in jackson. here some information i found on it...
Arikace tm - A Potential New Weapon in the Treatment of Gram-Negative Lung Infections
Pseudomonas Infections in Cystic Fibrosis Patients
There are over 70,000 cystic fibrosis patients in the U.S. and Europe. According to the Cystic Fibrosis Foundation (Patient Registry, 2005), 85% of cystic fibrosis patients will contract Pseudomonas aeruginosa lung infections by age 18. Although improved inhaled therapies and nutrition have increased the average life expectancy of a cystic fibrosis patient to 36.8 years, compared to 31 years in the 1990's, improvements still need to be made in enhancing the efficacy of inhaled antibiotic therapy and, most importantly, the patient's quality of life.
Some cystic fibrosis patients spend almost 3-5 hours per day taking medications, including inhaled antibiotics. The current gold-standard inhaled antibiotic is administered twice daily for 28 days followed by a 28-day period "off drug." Any Inhaled treatment that may reduce the weekly treatment burden of a cystic fibrosis patient could represent a significant breakthrough in improving the patient's quality of life.
CF patients produce and build up sputum and the Pseudomonas aeruginosa infection creates a biofilm, which together act as barriers protecting the bacteria from attack. Penetration of this barrier by conventional antibiotics may be impaired and, thus, treatments may be unable to deliver effective dose levels to attack the infection. In addition, many studies have shown that drugs delivered to the lung often have a very short residence time in the lung and are cleared rapidly into the blood stream.
The proprietary liposomal technology upon which Arikace tm is based may make it possible for the antibiotic to overcome the physical barriers presented by the CF patient's own mucus and by the infection's biofilm. Transave has conducted in vitro experiments, which demonstrate that Arikace tm liposomes penetrate into both human CF sputum and the biofilm of Pseudomonas aeruginosa macro-colonies. Attaining close proximity to the bacteria may significantly enhance the antimicrobial effect of Arikace tm as secreted virulence factors from the bacteria have been found to facilitate release of drug from the Arikace tm liposomes. In other words, by causing the liposomes to leak, the drug is released where it is needed most and, thus, the bacteria participate in their own demise. It is postulated that relatively high concentrations of a drug can be delivered locally to the site of an infection thus forming the basis of the possibly enhanced efficacy of Arikace tm.
The sustained-release delivery of a drug may reduce dosing frequency to one time per day or less, thereby easing a patient's treatment burden and potentially improving patient compliance. Sustained release of the antibiotic above the therapeutic level (minimal level of drug needed to kill Pseudomonas aeruginosa) may also decrease the potential for the development of resistant strains of bacteria.
The overall product profile that Transave is working to develop for Arikace tm may potentially lead to broader patient usage in the U.S. and Europe and possibly result in: (1) enhanced efficacy through biofilm penetration and facilitated release (virulence factors), (2) reduced dosing frequency, (3) decreased side effects, and; (4) decreased time for administration.
Transave's Arikace tm is locally delivered via inhalation using state of the art nebulizers that may be utilized by cystic fibrosis patients for other inhaled therapies. Transave continues to seek alternatives to the current nebulizer and compressor systems to facilitate speedier delivery of the drug with greater portability than currently available systems.
Arikace tm clinical trials are underway to assess its safety and efficacy, including potential improvements in pulmonary function (FEV-1) and reductions in bacterial load (CFU counts).
Arikace tm has been granted Orphan Drug status in both the U.S. and Europe for lung infections in CF patients that are caused by Pseudomonas aeruginosa.
Other Potential Uses
Arikace tm is also being explored for use in other potential lung infections, such as mycobacterium and bronchiectasis due to susceptible organisms.
