Healthcare Industry News: Bronchiectasis
News Release - October 25, 2007
Aradigm Corporation Reports Initial Human Data on a Novel Approach to Treatment of Tobacco Smoking Addiction Using its AERx Essence(R) Nicotine InhalerPhase 1 Data Presented at the National Conference on Tobacco or Health in Minneapolis
MINNEAPOLIS--(HSMN NewsFeed)--Aradigm Corporation (OTC BB: ARDM ) today presented Phase 1 trial results demonstrating that inhaling water solution of nicotine using Aradigm’s AERx Essence® palm-size inhaler results in very rapid absorption of nicotine into the blood stream and appears to be associated with acute reduction of craving for cigarettes. Aradigm believes these results provide the foundation for further research with the AERx Essence device as a means toward smoking cessation. These results were made public via a poster presentation by Tunde Otulana, M.D., Aradigm’s Chief Medical Officer, at the National Conference on Tobacco or Health underway at the Minneapolis Convention Center.
"Tobacco smoking is a major public health problem in the United States, as it can lead to cancer, chronic obstructive pulmonary disease and cardiovascular disease. Despite enormous public health efforts and several approved treatments, the majority of smokers who try to quit are unable to give up this addiction,” says Adam Wanner, M.D., Professor of Medicine, from the Division of Pulmonary and Critical Care Medicine at the University of Miami’s Miller School of Medicine. “The Aradigm trial results, albeit from an early stage study, point toward the possibility of using pure nicotine, without the other dangerous disease-causing constituents of tobacco smoke, for more effective cessation therapy than the existing treatments."
Aradigm’s randomized, open-label, single-site Phase 1 trial evaluated arterial plasma pharmacokinetics and subjective acute cigarette craving when one of three nicotine doses (0.2mg, 0.4mg and 0.7mg) was administered to 18 adult male smokers. Blood levels of nicotine rose much more rapidly following a single-breath inhalation compared to published data on other approved nicotine delivery systems. Cravings for cigarettes were measured on a scale from 0-10 before and after dosing for up to four hours. Prior to dosing, mean craving scores were 5.5, 5.5 and 5.0, respectively, for the three doses. At five minutes following inhalation of the nicotine solution through the AERx Essence device, craving scores were reduced to 1.3, 1.7 and 1.3, respectively, and did not return to pre-dose baseline during the four hours of monitoring. Nearly all subjects reported an acute reduction in craving or an absence of craving immediately following dosing. No serious adverse reactions were reported in the study.
"Smoking researchers have believed for some time that a ‘pure nicotine’ pulmonary inhaler that would produce rapid absorption of nicotine into the blood stream, similar to that obtained from tobacco cigarette smoking, could be an important tool in the effort to reduce tobacco-induced disease,” says Neal L. Benowitz, M.D., Professor of Medicine, Psychiatry and Biopharmaceutical Sciences and Chief, Division of Clinical Pharmacology at the University of California, San Francisco. “Such an inhaler used instead of a cigarette would eliminate exposure to the combustion products that are primarily responsible for disease, and might be an effective smoking cessation treatment. Aradigm's inhaler in this trial appears to yield the desired nicotine pharmacokinetic profile; and the impact on the acute craving for cigarettes is also encouraging."
“Aradigm is dedicated to the development of therapies for prevention and treatment of severe respiratory disease,” says Igor Gonda, Ph.D., Aradigm’s President and CEO. “We are encouraged by these clinical findings and we will pursue potential partnerships with industry and other organizations to investigate further the utility of our nicotine inhalation technology to address a major global medical problem that is also very significantly affecting the United States.”
According to the National Center for Health Statistics (NCHS), 21% of the U.S. population age 18 and above currently smokes cigarettes. The World Health Organization (WHO) estimates that 650 million people worldwide are smokers, which results in a health cost equivalent to $200 billion, $75 billion in the U.S. alone. Further, the NCHS indicates that nicotine dependence is the most common form of chemical dependence in this country. As a result, quitting tobacco use is difficult and oftentimes requires multiple attempts, as users often relapse because of withdrawal symptoms.
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 by pulmonologists. Current activities include partnered and self-initiated development programs addressing the treatment of cystic fibrosis, Bronchiectasis, pulmonary hypertension, asthma and bronchitis, inhalation anthrax infections and smoking cessation.
In addition, Aradigm's AERx® insulin Diabetes Management System (iDMS), which has been licensed to Novo Nordisk for development and commercialization in return for royalties, is in Phase 3 testing for Type 1 and Type 2 diabetes. Under the agreements with Novo Nordisk, Novo Nordisk is responsible for all further clinical, manufacturing and commercial development, while Aradigm and Novo Nordisk continue to cooperate and share in technology development, as well as intellectual property development and defense. 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 the timing of clinical trials and the receipt of royalty and other payments as well as the other risks detailed in Aradigm Corporation's Securities and Exchange Commission (SEC) Filings, including Aradigm's Annual Report on Form 10-K, and quarterly reports on Form 10-Q.
Aradigm, AERx, and AERx Essence are registered trademarks and the Aradigm Logo is a trademark of Aradigm Corporation.
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.