Aradigm and APT Pharmaceuticals
Announce Progression Into Phase 2 Clinical Trials
HAYWARD, CA and TUCSON, AZ – JULY 1,
2005
Aradigm Corporation (NASDAQ: ARDM) and APT
Pharmaceuticals Inc., a privately held biotechnology company,
today announced the program advancement of APT’s proprietary
formulation of hydroxychloroquine (HCQ) into Phase 2 clinical
trials. APT and Aradigm are developing this aerosolized formulation
of the anti-inflammatory agent HCQ in Aradigm’s AERx
pulmonary delivery system as a new class of treatment for asthma
and chronic obstructive pulmonary disease.
As part of the APT-funded program, Aradigm
will source the active pharmaceutical ingredient, conduct the
formulation development of the drug product, manufacture clinical
supplies and execute regulatory and clinical development.
“This partnership combines an innovative
formulation of a powerful anti-inflammatory agent with the
efficient and precise delivery capabilities of the AERx System,” said
Stephen Farr, Ph.D., Senior Vice President and Chief Scientific
Officer of Aradigm. “We are very pleased with positive
AERx HCQ clinical results to date and in the progression of
this and the other AERx programs in our clinical pipeline.”
Aradigm and APT recently completed a Phase
1 study in healthy volunteers, which determined that AERx delivered
HCQ had a favorable safety and tolerability profile that enabled
progression into the Phase 2 clinical program.
“After extensive review, APT chose
Aradigm’s AERx system for its ability to selectively
deliver HCQ to the deep lung with minimal mouth and throat
deposition which has been one of our primary goals,” said
APT President Gino Di Sciullo, Ph.D. “Now we have a delivery
platform with optimal parameters that enables us to examine
the anti-inflammatory effects of the drug in asthma. We are
very pleased to continue our clinical development partnership
with Aradigm for the AERx pulmonary product line.”
Recently, APT closed a round in a Series
A financing with Charter Life Sciences and Research Corporation
Technologies. The financing positions the company to continue
its pulmonary product development program with Aradigm.
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). U.S. Patent No.
6,572,858 and other pending worldwide patent applications protect
the APT technology.
About Aradigm Corporation
Aradigm develops non-invasive delivery systems to enable
patients to comfortably self-administer biopharmaceuticals
and small molecules. The company’s advanced AERx® pulmonary
and Intraject® needle-free delivery technologies offer
rapid delivery solutions for liquid drug formulations. Current
development programs focus on neurological disorders, heart
disease, respiratory conditions, diabetes and cancer. 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, 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.
AERx and Intraject are registered trademarks
of Aradigm.
CONTACT:
Christopher Keenan
Aradigm Corporation
510-265-9370
or Jan McCoy Hutchinson
APT Pharmaceuticals Inc.
520-748-4458 |
