Corus Pharma's Phase III Trial for Cystic Fibrosis Drug Is First to Feature PARI's eFlow Marks Customization in Drug/Device Matc

Main Category: Cystic Fibrosis
Article Date: 26 Apr 2005 - 13:00 PDT

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Corus Pharma's AIR-CF2 Phase III trial, which began enrolling patients this month, is the first Phase III trial that matches PARI's eFlow electronic nebulizer with a product formulation specifically developed to optimize the device's performance. The optimization of formulation to device and device to formulation represents a new advance in the customization of drug development.

Corus Pharma's Phase III trial for aztreonam lysinate for inhalation (AI) is a multi-center, blinded, placebo-controlled trial that will be conducted in 50 cystic fibrosis centers in the United States. It will evaluate the safety and efficacy of AI in patients with pulmonary Pseudomonas aeruginosa, bacteria that commonly infect the lungs of cystic fibrosis patients.

Aztreonam is an antibiotic that is currently approved in an intravenous form to treat a broad spectrum of gram-negative bacteria, including Pseudomonas aeruginosa. Inhaled delivery increases the concentration of the drug at the site of infection as compared to intravenous administration. Corus has chosen to work closely with PARI Aerosol Research Institute to develop the inhalation formulation and deliver AI with eFlow. eFlow, a portable electronic nebulizer, features TouchSpray technology that uses a vibrating mesh to dictate particle size.

"Aztreonam lysinate for inhalation was an excellent opportunity for us to demonstrate our formulation and analytical expertise and to develop a stable and sterile product. This opportunity allowed the PARI Aerosol Research Institute to optimize the drug formulation to our advanced device and customize the eFlow platform for this application," said Dr. Manfred Keller, Director of PARI Business Unit Pharma.

eFlow's advances give AI an approximate delivery time of less than three minutes as shown in Corus's Phase II trial. Currently other therapies using jet nebulizers take 15-20 minutes to deliver aerosolized antibiotic doses. "Cystic fibrosis patients are often prescribed multiple medications and therapies that consume a significant amount of time. Our goal is to shorten the time of administration as much as possible, targeting a delivery time of less than three minutes. In order to achieve this goal, it was important to pick a state-of-the-art device for our clinical trials which could be used with a customized formulation. We feel this has the potential to offer a substantial benefit for CF patients," said Jonathan Mow, Vice President, Commercial & Business Development for Corus Pharma.

Compared to other nebulizer systems, eFlow can produce aerosols with a high concentration of active ingredients, a defined droplet size, and a high proportion of respirable droplets in a shorter amount of time. Its silent mode of operation, small size (it can be held in one hand), lightweight, and battery use make this device extremely user-friendly.

About Cystic Fibrosis (CF)

Cystic fibrosis is a genetic disease affecting approximately 30,000 children and adults in the United States. One in 31 Americans (more than 10 million people) is an unknowing, symptomless carrier of the defective gene. CF causes the body to produce abnormally thick, sticky mucus that clogs the lungs, obstructs the pancreas, and leads to life-threatening lung infections. According to the CF Foundation's National Patient Registry, the median age of survival for a person with CF is 33.4 years. As more advances have been made in the treatment of CF, the number of patients aging with CF has steadily grown. Today, nearly 40 percent of the CF population is age 18 and older.

About PARI Aerosol Research Institute

The PARI Aerosol Research Institute is a division of PARI GmbH focusing on both new aerosol delivery platform technologies and novel pharmaceutical formulations. The Aerosol Research Institute specializes in device development, engineering, aerosol testing, and product manufacturing. The GMP-certified Aerosol Research Institute is equipped and capable of providing full service support for pharmaceutical formulation development and analytics for submission of CMC-packages with U.S. and European regulatory bodies.

PARI Aerosol Research Institute is also in the unique position of helping pharmaceutical companies develop innovative new medication formulations (such as nanosized liposomes) with customized drug-device matching, because eFlow provides the potential for significantly reduced medication doses and treatment times. The potential for creating improved formulations, or new uses for approved active ingredients, is also greater with eFlow due to its innovative technology platform.

PARI GmbH, a privately held company founded in 1906, is considered the worldwide leader in aerosol delivery via efficient nebulizer systems. PARI products are well established in clinical trials for existing and new respiratory medications for COPD, asthma, and cystic fibrosis. PARI products are available in over 70 countries worldwide.

Web site: http://www.pari.de

SOURCE PARI Aerosol Research Institute
http://www.pari.de

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