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ARD-3100/3150 (Pulmaquin, Lipoquin)

ARD-1100

ARD-1600

Scientific Publications

We have demonstrated in human clinical trials to date effective deposition, safety, efficacy and, where required, systemic absorption of a wide variety of drugs, including small molecules, peptides and proteins, using our AERx delivery inhalation platform, for example:

AERx Pure Nicotine Inhaler

Our AERx inhaler was tested in current smokers with pure nicotine dissolved in water. A single breath from this elegant inhaler that requires no electric power, caused an immediate profound reduction of craving for cigarettes that lasted for several hours. We have multiple issued patents and patent applications in the area of nicotine delivery and smoking cessation. This product is available for partnering or as an investment opportunity.

Scientific Publications
Cipolla D. and Gonda I. Inhaled Nicotine Replacement Therapy. Asian J Pharm Sci. 2015. 10(6): 472-480.

Gonda I. et al. Smoking Cessation Approach Via Deep Lung Delivery of ‘Clean’ Nicotine. RDD Europe 2009. Dalby R.N. et al. (eds). 2009. 57-62.

Cipolla D. et al. Development of an Inhaled AERx Essence Nicotine Product for Smoking Cessation. RDD 2008. Dalby R.N. et al. (eds). 2008. 365-369.

Cipolla D and Johansson E. AERx Pulmonary Drug Delivery Systems. Drugs and the Pharmaceutical Sciences, Modified Release Drug Delivery Technology. Second Edition. MJ Rathbone, J Hadgraft, MS Roberts, ME Lane (eds). Published by Informa Healthcare. 2008. 184: 563-572.

• Pain Management System

Based on our internal work and a currently dormant collaboration with GlaxoSmithKline, we have developed a significant body of preclinical and Phase 1 clinical data on the use of inhaled morphine and fentanyl, and Phase 2 clinical data on inhaled morphine, with our proprietary AERx inhaler for the treatment of breakthrough pain in cancer and postsurgical patients.

Scientific Publications
Cipolla D and Johansson E. AERx Pulmonary Drug Delivery Systems. Drugs and the Pharmaceutical Sciences, Modified Release Drug Delivery Technology. Second Edition. MJ Rathbone, J Hadgraft, MS Roberts, ME Lane (eds). Published by Informa Healthcare. 2008. 184: 563-572.

Gonda I. et al. Inhalation Delivery Systems with Compliance and Disease Management Capabilities. J Control Rel. 1998. 53:269-274.

Mather L.E. et al. Pulmonary Administration of Aerosolized Fentanyl: Pharmacokinetic Analysis of Systemic Delivery. Br J Clin Pharmacol. 1998. 46:37-43.

Derschwitz M. et al. Pharmacokinetics and Pharmacodynamics of Inhaled Versus Intravenous Morphine in Healthy Volunteers. Anesthesiology. 2000. 93(3): 619-628.  

AERx insulin Diabetes Management System (iDMS)

(Inhalable Insulin)

Providing a needle-free alternative to diabetes management with insulin.

Insulin is the natural hormone produced in the pancreas that controls the blood levels of glucose in humans and animals. Patients with diabetes have abnormally high glucose levels. The AERx iDMS inhalable insulin is a convenient, patient-friendly approach to insulin delivery that can be used as a replacement for, or adjunct to, conventional therapies to control blood glucose levels in diabetes.

According to the World Health Organization (WHO), the number of people with diabetes has risen from 108 million in 1980 to 422 million in 2014. Diabetes is a major cause of blindness, kidney failure, heart attacks, stroke and lower limb amputation. In 2012, an estimated 1.5 million deaths were directly caused by diabetes and another 2.2 million deaths were attributable to abnormally high blood glucose. Almost half of all deaths attributable to high blood glucose occur before the age of 70 years. WHO projects that diabetes will be the 7th leading cause of death in 2030. Type 2 diabetes results from the body’s ineffective use of insulin. Type 2 diabetes comprises the majority of people with diabetes around the world, and is largely the result of excess body weight and physical inactivity. While many Type 2 diabetes patients can initially maintain adequate control over blood glucose levels through diet, exercise and oral medications, most Type 2 patients will require insulin therapy. Type 1 diabetes is characterized by deficient insulin production and requires daily administration of insulin.

AERx iDMS has been tested extensively in preclinical studies, healthy volunteers as well as in subjects with Type 1 and Type 2 diabetes in Phase 1-3 clinical trials. Aradigm is seeking a collaboration partner to complete the development and commercialization of this candidate product.

As with any clinical program, there are many factors that could delay the launch or result in AERx iDMS not receiving or maintaining regulatory approval.

Scientific Publications
Cipolla D and Johansson E. AERx Pulmonary Drug Delivery Systems. Drugs and the Pharmaceutical Sciences, Modified Release Drug Delivery Technology. Second Edition. MJ Rathbone, J Hadgraft, MS Roberts, ME Lane (eds). Published by Informa Healthcare. 2008. 184: 563-572.

Gonda I. et al. Inhalation Delivery Systems with Compliance and Disease Management Capabilities. J Control Rel. 1998. 53:269-274.

Thipphawong J. et al. Pulmonary Insulin Administration Using the AERx® Insulin Diabetes System. Diabetes Technology & Therapeutics. 2002. 4(4): 499-504.

Brunner G.A. et al. Dose-Response Relation of Liquid Aerosol Inhaled Insulin in Type I Diabetic Patients. Diabetologia. 1991. 44: 305-308.

Hermansen K, et al. Intensive Therapy With Inhaled Insulin via the AERx Insulin Diabetes Management System. 2004; 27(1); 162-7.

• Other Programs

We have successfully tested the AERx inhaler with recombinant human DNase in patients with cystic fibrosis. We have preclinical and clinical data available for a number of other therapeutics delivered using this platform, both for local and systemic drug delivery.

Scientific Publications
Cipolla D and Johansson E. AERx Pulmonary Drug Delivery Systems. Drugs and the Pharmaceutical Sciences, Modified Release Drug Delivery Technology. Second Edition. MJ Rathbone, J Hadgraft, MS Roberts, ME Lane (eds). Published by Informa Healthcare. 2008. 184: 563-572.

Chattopadhyay P. et al. Production of solid lipid nanoparticle suspensions using supercritical fluid extraction of emulsions (SFEE) for pulmonary delivery using the AERx system. Adv Drug Del Rev. 2007. 59(6):444-453.

Shekunov B. et al. AERx Aerosol Properties of Drug-Lipid Nanosuspensions Produced using Supercritical Fluid Extraction of Emulsions (SFEE). RDD X. Dalby R.N. et al. (eds). 2006: 609-612.

Dayton F. et al. Development of an Inhaled Hydroxychloroquine Sulfate Product using the AERx System to Treat Asthma. RDD X. Dalby R.N. et al. (eds). 2006: 429-432.


Okumu F.W. et al. Evaluation of the AERx Pulmonary Delivery System for Systemic Delivery of a Poorly Soluble Selective D-1 Agonist, ABT-431. Pharm Res. 2002. 19(7): 1009-1012.


Deshpande D. et al. Development of an AERx System for Delivery of Bioscavengers. RDD IX. Dalby R.N. et al (eds). 2004: 349-351.


Cipolla D. et al. Bolus Administration of INS-365: Studying the Feasibility of delivering High Doses of Drug using the AERx Pulmonary Delivery System. RDD VII. Dalby R.N. et al. (eds). 2000. 231-239.

 

Davison S. et al. Pharmacokinetics and acute safety of inhaled testosterone in postmenopausal women. J. Clin. Pharmacol. 2005. 45: 177-184.

 

Chan H.K. et al. Deposition of Aqueous Aerosol of Technetium-99m Diethylene Triamine Penta-acetic Acid Generated and Delivered by a Novel System (AERx) in Healthy Subjects. Eur J Nuclear Medicine. 1999. 26(4): 320-37.

 

Sangwan S. et al. Aerosolized Protein Delivery in Asthma: Gamma Camera Analysis of Regional Deposition and Perfusion. J. Aerosol Med. 2001. 14(2): 185-195.

 

Cipolla D. et al. Delivery of Biologics to the Lung. New Drugs for Asthma, Allergy and COPD. TT Hansel and PJ Barnes (eds). Published by S. Karger AG, Basel, Switzerland. 2001. 30: 20-23.

Deshpande D. et al. Gamma scintigraphic evaluation of a miniaturized AERx Pulmonary Delivery System for aerosol delivery to anesthetized animals using a positive pressure ventilation system. J. Aerosol Med. 2005. 18: 34-44.

 

Mudumba S. et al. Non-Viral Delivery of COX-1 Gene by the Pulmonary Delivery System. RDD IX. Dalby R.N. et al. (eds). 2004. 353-355.

 

Desphande D. et al. Aerosolization of Lipoplexes Using AERx® Pulmonary Delivery System. AAPS PharmSci. 2002. 4(3): 1-10.

 

 

 

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