Aradigm and APT Pharmaceuticals
Initiate Phase 2 Clinical Program of Novel Treatment for Asthma
HAYWARD, CA and TUCSON, AZ – MARCH
23, 2006
Aradigm Corporation (NASDAQ: ARDM) and APT
Pharmaceuticals Inc., a privately held biotechnology company,
today announced the initiation of their Phase 2 clinical trial
investigating aerosolized hydroxychloroquine (HCQ) as an anti-inflammatory
treatment for asthma. This clinical program will investigate
the safety and efficacy of a novel aerosolized formulation
of HCQ using Aradigm’s AERx® pulmonary delivery system.
The Phase 2 trial is a randomized, double-blind,
placebo-controlled, multi-dose study in patients with asthma.
The trial will enroll approximately 100 patients with moderate
- persistent asthma who will be randomized to one of two treatments
groups: either aerosolized placebo or aerosolized HCQ given
once daily for 21 consecutive days. Both treatment groups will
be administered via the AERx System with efficacy, safety and
tolerability assessments being performed throughout the study.
The trial is being conducted at multiple
study sites and follows favorable data from a Phase 1 human
trial completed last year with AERx and a previously executed
pre- clinical study both using an aerosolized formulation.
Aerosolized HCQ enables delivery of the
drug directly to the lower airways and in preclinical studies
has been shown to dramatically reduce the time required to
achieve improvement in airflow from months, as seen with the
oral formulation, to a few days.
“We are very pleased to see this program
progress on schedule and with a group of renowned clinical
investigators who share our enthusiasm for the potential of
this novel approach for the treatment of asthma,” said
Tunde Otulana, M.D. Vice President of Clinical and Regulatory
Affairs at Aradigm. “We believe that this novel therapeutic
product that combines the advantages of an innovative formulation
with the AERx targeted delivery system has the potential to
offer significant advantages to many patients over traditional
asthma treatments.”
"Given HCQ’s classification as a disease
modifying antirheumatic drug (DMARD), we are optimistic that
our aerosolized HCQ delivered to the lung with Aradigm’s
AERx system will show rapid therapeutic benefit to asthmatic
patients,” said APT President Gino Disciullo, Ph.D. “We
are pleased to continue our clinical partnership with Aradigm
in developing APT's pulmonary product line.”
According to Datamonitor, a leading market
research company, asthma is a major medical problem that is
expected to affect approximately 35.1 million people worldwide
by 2015. In 2004, the annual cost to treat asthma exceeded
$16 billion dollars in the United States alone.
About APT Pharmaceuticals
Inc.
APT is a clinical-stage company developing products
to treat respiratory diseases. The company is developing steroid
alternative therapies based on novel reformulations and methods
of treatment with hydroxychloroquine (HCQ). APT recently closed
a $9 million Series A financing with Charter Life Sciences,
Research Corporation Technologies and Vivo Ventures. The financing
positions APT to continue its pulmonary product development
program with Aradigm.
About Aradigm Corporation
Aradigm combines its non-invasive delivery systems with
novel formulations to create products that enable patients
to comfortably self-administer biopharmaceuticals and small
molecule drugs. The company’s advanced AERx® pulmonary
and Intraject® needle- free delivery technologies offer
rapid delivery solutions for liquid drug formulations. Current
development programs and priorities focus on the development
of specific products, including partnered and self-initiated
programs in the areas of respiratory conditions, neurological
disorders, heart disorders, and smoking cessation. In addition,
Aradigm and its partner, Novo Nordisk, are in Phase 3 clinical
trials of the AERx Diabetes Management System for the treatment
of Type 1 and Type 2 diabetes. More information about Aradigm
can be found at www.aradigm.com.
Except for the historical information contained
herein, this news release contains forward-looking statements
that involve risk and uncertainties, including clinical results,
the timely availability and acceptance of new products, the
impact of competitive products and pricing, the availability
of funding from partners or capital markets, and the management
of growth, as well as the other risks detailed from time to
time in Aradigm Corporation's Securities and Exchange Commission
(SEC) Filings, including the company's Annual Report on Form
10-K, and quarterly reports on Form 10-Q.
Aradigm, AERx and Intraject are registered
trademarks of Aradigm.
CONTACTS:
Christopher Keenan
Aradigm
(510) 265-9370
Jan McCoy Hutchinson
APT Pharmaceuticals Inc.
(520) 748-4458
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