(Liposomal Ciprofloxacin - Lipo Cip)
Development of a new way to treat chronic
debilitating and life-threatening respiratory infections in cystic
fibrosis.
Ciprofloxacin is approved by the FDA as an anti-infective agent
in the form of tablets and injections and is widely used for the
treatment of a variety of bacterial infections. We believe that
delivering this potent antibiotic directly to the lung may improve
its safety and efficacy in the treatment of pulmonary infections.
Our novel sustained release formulation of ciprofloxacin is designed
with the view that it will maintain therapeutic concentrations of
the antibiotic within infected lung tissues, while reducing systemic
exposure and the resulting side effects seen with currently marketed
ciprofloxacin products. To achieve this sustained release, we employ
liposomes, which are lipid-based nanoparticles dispersed in water
that encapsulate the drug during storage and release the drug slowly
in the lung. In an animal experiment, ciprofloxacin delivered to
the lung of mice appeared to be rapidly absorbed into the bloodstream,
with no drug detectable four hours after administration. In contrast,
the liposomal formulation of ciprofloxacin produced significantly
higher levels of ciprofloxacin in the lung at all time points and
was still detectable at 12 hours. We also believe that for certain
respiratory disease indications it may be possible that a liposomal
formulation enables better interaction of the drug with the disease
target, leading to improved effectiveness over other therapies.
We have at present two target indications with distinct delivery
systems for this formulation that share much of the laboratory and
production development efforts, as well as a common safety data
base.
ARD-3100 - Liposomal Ciprofloxacin for the Treatment
of Cystic Fibrosis
This proprietary program using our liposomal formulation of ciprofloxacin
for the treatment and control of respiratory infections common to
patients with cystic fibrosis, or CF. CF is a genetic disease that
causes thick, sticky mucus to form in the lungs, pancreas and other
organs. In the lungs, the mucus tends to block the airways, causing
lung damage and making these patients highly susceptible to lung
infections. According to the Cystic Fibrosis Foundation, CF affects
roughly 30,000 children and adults in the United States and roughly
70,000 children and adults worldwide. According to the American
Lung Association, the direct medical care costs for an individual
with CF are currently estimated to be in excess of $40,000 per year.
The inhalation route affords direct administration of the drug
to the infected part of the lung, maximizing the dose to the affected
site and minimizing the wasteful exposure to the rest of the body
where it could cause side effects. Therefore, treatment of CF-related
lung infections by direct administration of antibiotics to the lung
may improve both the safety and efficacy of treatment compared to
systemic administration by other routes, as well as improving patient
convenience as compared to injections. Oral and injectable forms
of ciprofloxacin are approved for the treatment of Pseudomonas aeruginosa,
a lung infection to which CF patients are vulnerable. Currently,
there is only one inhalation antibiotic approved for the treatment
of this infection. We believe that local lung delivery via inhalation
of ciprofloxacin in a sustained release formulation could provide
a convenient, effective and safe treatment of the debilitating and
often life-threatening lung infections that afflict patients with
CF.
Our liposomal ciprofloxacin CF program represents the first program
in which we intend to retain full ownership and development rights.
We intend to commercialize this program on our own.
We have received orphan drug designation from the FDA for this product
for the management of CF. As a designated orphan drug, liposomal
ciprofloxacin is eligible for tax credits based upon its clinical
development costs, as well as assistance from the FDA to coordinate
study design. The designation also provides the opportunity to obtain
market exclusivity for seven years from the date of New Drug Application,
or NDA, approval.
We also intend to explore the utility of liposomal ciprofloxacin
for the treatment of serious infections associated with other respiratory
diseases, such as non-CF bronchiectasis.
Scientific Publications
Aradigm scientists have published extensively on aerosol formulation
and pulmonary drug delivery. Following are citations relating to
cystic fibrosis and/or liposomal ciprofloxacin.
Geller, D. et al.: "Bolus Inhalation of rhDNase with the AERx
System in Subjects with Cystic Fibrosis" Journal of Aerosol
Medicine 2003. 16(2): 175-182.
Cipolla, D. et al., Bolus Administration of INS365: Studying the
Feasibility of Delivering High Dose Drugs Using the AERx® Pulmonary
Delivery System, in Respiratory Drug Delivery VII, 2000, Eds. Dalby,
R., et al., Serentec Press, Inc., Raleigh, NC, pp. 231-239 (2000).
Educational Links
For more information on cystic fibrosis, visit the following web sites:
Cystic Fibrosis Foundation
MedlinePlus
Cystic Fibrosis | A Support Community

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