Aradigm Presents Phase 1 & Phase 2 Data on Inhaled Liposomal Ciprofloxacin in Healthy Volunteers & Cystic Fibrosis Patients a...
June 11 2009 - 7:00AM
Business Wire
Aradigm Corporation (OTCBB:ARDM) ("Aradigm") today announced it
is presenting data from its Phase 1 study in healthy volunteers and
Phase 2a study of inhaled liposomal ciprofloxacin in cystic
fibrosis (CF) patients at the 32nd European Cystic Fibrosis
Conference in Brest, France.
POSTER NUMBER: # 196
ABSTRACT TITLE: Pharmacokinetics and Antibacterial
Activity of Inhaled Liposomal Ciprofloxacin Hydrochloride in
Healthy Volunteers and in Cystic Fibrosis (CF) patients
AUTHORS: Paul Bruinenberg MD, Babatunde Otulana MD, Jim
Blanchard PhD, David Cipolla Msc, John Wilson MD*, David Serisier
MD**, Aradigm Corporation, Hayward, CA. * The Alfred Hospital
Melbourne Australia, ** Mater Adult Hospital, Brisbane,
Australia
SCHEDULED: Thursday, June 11, 2009 through Saturday, June
13, 2009.
The results demonstrated in both healthy volunteers and cystic
fibrosis patients similar pharmacokinetics of inhaled liposomal
ciprofloxacin, with a long systemic elimination half life (t�) of
~10.5 hours supporting a once-daily dosing allowing for less
frequent dosing than current inhaled antibiotic regimes. As
reported before, this treatment was effective to result in highly
significant reduction in the sputum of Pseudomonas Aeruginosa
colony forming units (CFU), an objective measure of the reduction
in pulmonary bacterial load in the CF patients. The promising
efficacy data is also supported by the high concentration of
ciprofloxacin found in the sputum of CF patients following
treatment with inhaled liposomal ciprofloxacin.
Ciprofloxacin is a widely prescribed antibiotic to treat
infections of the lung frequently experienced by CF patients. It is
often preferred because of its broad-spectrum anti-bacterial
action. The available oral and intravenous formulations of the drug
are used to treat episodes of acute exacerbations of lung
infections. Aradigm's once-a-day novel inhaled formulation of
ciprofloxacin delivered in liposomes is to be used for chronic
maintenance therapy as it is expected to achieve higher antibiotic
concentration at the site of infection and relatively low systemic
antibiotic concentrations to minimize side-effects.
About the 32nd European Cystic Fibrosis Conference
The International Conference of the American Thoracic Society
(ATS) is the leading scientific meeting organized by European
Cystic Fibrosis Society where CF and pulmonary physicians,
researchers and allied health professionals around the world gather
to learn from each other and build collaborations.
More information about the 32nd European Cystic Fibrosis
Conference can be found at http://www.ecfs.eu/brest2009
About Aradigm
Aradigm is an emerging specialty pharmaceutical company focused
on the development and commercialization of a portfolio of drugs
delivered by inhalation for the treatment of severe respiratory
diseases by pulmonologists. Current activities include partnered
and self-initiated development programs addressing the treatment of
cystic fibrosis, bronchiectasis, COPD, inhalation anthrax
infections and smoking cessation.
More information about Aradigm can be found at
www.aradigm.com.
Forward-Looking Statements
Except for the historical information contained herein, this
news release contains forward-looking statements that involve risk
and uncertainties, including the timing and results of clinical
trials as well as the other risks detailed in Aradigm Corporation's
Securities and Exchange Commission (SEC) Filings, including
Aradigm's Annual Report on Form 10-K, and quarterly reports on Form
10-Q.
Aradigm and the Aradigm Logo are registered trademarks of
Aradigm Corporation.