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| [November 19, 2012] |
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UK Scientists Report on Efficacy of Aradigm's Lipoquin™ Against Pneumonic Plague
HAYWARD, Calif. --(Business Wire)--
Scientists from the UK Defence Science and Technology Laboratory (Dstl)
report, in a preliminary study, that they have demonstrated that a
single dose of Aradigm Corporation's (OTCBB:ARDM) (the "Company")
liposomal ciprofloxacin formulation Lipoquin administered 24 hours after
exposure to a lethal dose of the bacterium Yersinia pestis provided
full protection in a murine model of pneumonic plague. In comparison, a
single dose of oral ciprofloxacin administered 24 hours post-exposure
provided no protection.
The Gram-negative bacterium Yersinia pestis is the causative
agent of plague, a disease thought to be responsible for the death of
200 million people through devastating pandemics such as the Black
Death. Inhalation of Y. pestis can result in the most severe form
of the disease, pneumonic plague, which if untreated may have a
mortality rate of 100%. Currently, there is no licensed vaccine for use
in humans.
In the study, the animals were followed for up to 28 days post-exposure.
Exposure to aerosolized Y. pestis was lethal with all untreated
mice succumbing to a systemic infection by day 3 post-exposure. A single
dose of oral ciprofloxacin administered at 24 hours post-exposure did
not prevent mortality and only increased the mean time to death to 5
days compared to 3 days for untreated mice. In comparison, a single dose
of Lipoquin delivered via the nose into the lungs of the animals
provided 100% protection and significantly improved survival compared to
a single dose of oral ciprofloxacin (P<0.0001); a single dose of
aerosolized Lipoquin administered at 24 hours post-exposure provided
approximately 70% protection and significantly improved survival when
compared to a single dose of oral ciprofloxacin (P<0.001).
In their report, the scientists state that the study demonstrated the
superior efficacy of Lipoquin compared to oral ciprofloxacin as
post-exposure prophylaxis against Y. pestis.
Scientists at Dstl previously demonstrated the efficacy of Lipoquin
compared to oral ciprofloxacin against Francisella tularensis (the
causative agent of tularemia) infection using the highly virulent SCHU
S4 strain: a single dose of aerosolized Lipoquin provided full
protection against lethal exposure in a murine model of F. tularensis
infection. In addition, a single dose of aerosolized Lipoquin was
superior to a five-day course of twice-daily ora ciprofloxacin therapy,
which provided only minimal protection.
Additionally, in a previously reported collaborative study with the
Health Protection Agency and Dstl, Aradigm's inhaled liposomal
ciprofloxacin was shown to be effective in a mouse model against Coxiella
burnetii - the causative agent of the disease Q fever. C. burnetii
is endemic worldwide, infects a wide variety of animals and humans and
has a low infectious dose by the inhalational route. Clinical
presentation in humans may lead to an acute infection with flu-like
symptoms, or a chronic life-threatening disease. A recent epidemic of Q
fever in humans took place in the Netherlands in 2009, with 2,357
reported cases and 6 deaths. Current oral antibiotic treatment of Q
fever can be lengthy and complex.
"We are very excited to see that our inhaled liposomal ciprofloxacin has
been found to show very promising efficacy against three possible
bioterrorism agents, making it potentially a useful broad-spectrum
prophylaxis and treatment against such infections. We continue to seek
opportunities for additional funding for this type of work via
collaborations with government agencies with the view that our liposomal
ciprofloxacin may be approved under FDA and similar overseas regulations
relating to new drugs or biologics for potentially fatal diseases where
human studies cannot be conducted ethically or practically," said Igor
Gonda, President and CEO of Aradigm.
About inhaled ciprofloxacin (Pulmaquin™ and Lipoquin)
Ciprofloxacin is a widely prescribed antibiotic to treat infections of
the lung frequently experienced by cystic fibrosis (CF) and non-cystic
fibrosis bronchiectasis (BE) 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 in CF patients. The Company's
once-a-day novel inhaled formulations of ciprofloxacin are encapsulated
in liposomes, allowing for a sustained release of the drug within the
lung and improving airway tolerability. The formulations are to be used
for chronic maintenance therapy as they are expected to achieve higher
antibiotic concentration at the site of infection and relatively low
systemic antibiotic concentrations to minimize side-effects. Lipoquin is
a liposomal formulation of ciprofloxacin. Pulmaquin is a dual release
formulation that is a mixture of Lipoquin with unencapsulated
ciprofloxacin. Pulmaquin has been tested extensively in preclinical
tests, as well as in the ORBIT-2 Phase 2b bronchiectasis study in which
outstanding antimicrobial activity coupled with good safety and
tolerability was found, and, most importantly, the positive impact on
prevention of exacerbations compared to placebo was also observed. The
Company previously reported positive results in Phase 2a studies of 22
CF patients and 36 BE patients who received Lipoquin once-a-day for 2
(CF) or 4 (BE) weeks, respectively. Additionally, Aradigm is developing
these formulations as a potential medication for the prevention and
treatment of high threat and bioterrorism infections, such as inhaled
anthrax, tularemia and Q fever. Aradigm has been granted orphan drug
designation for liposomal ciprofloxacin for cystic fibrosis in the U.S.
and the E.U., and for the combination of liposomal ciprofloxacin and
free ciprofloxacin for BE in the U.S.
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. The Company
has product candidates addressing the treatment of bronchiectasis,
cystic fibrosis, inhalation tularemia and 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 ability of animal results to predict
efficacy in humans, as well as the other risks detailed from time to
time in the Company's filings with the Securities and Exchange
Commission (SEC (News - Alert)), including the Company's Annual Report on Form 10-K for
the year ended December 31, 2011 filed with the SEC on March 28, 2012,
and the Company's Quarterly Reports on Form 10-Q.
Aradigm, Pulmaquin, Lipoquin and the Aradigm Logo are registered
trademarks of Aradigm Corporation.
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