Date: Mar 23, 2006 Source: Market Wire (
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HAYWARD, CA and TUCSON, AZ, Mar 23, 2006 (MARKET WIRE via COMTEX News Network) -- 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.
Contact:
Christopher Keenan
Aradigm
(510) 265-9370
Jan McCoy Hutchinson
APT Pharmaceuticals Inc.
(520) 748-4458
SOURCE: Aradigm
