Mpex Reports Positive Phase II Results With Aeroquin, Delivered By PARI Pharma's EFlow Technology

Main Category: Cystic Fibrosis
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 15 Sep 2009 - 1:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

Mpex Pharmaceuticals, Inc. reported positive top line results from a Phase 2b clinical trial with Aeroquin, a novel aerosol formulation of levofloxacin delivered by an optimized Investigational eFlow Nebulizer System from PARI Pharma. In the Mpex cystic fibrosis trial, nebulized Aeroquin met the primary endpoint of reducing bacterial counts of Pseudomonas aeruginosa in sputum after 28 days of dosing versus placebo.

"It is exciting to see these positive results with Mpex's Aeroquin delivered by an optimized Investigational eFlow Nebulizer System. We are seeing a variety of studies showing great results when inhaled medications are optimized for delivery with a customized Investigational eFlow Nebulizer System. This is good news for cystic fibrosis patients and their care givers," said Martin Knoch, president of PARI Pharma Gmbh.

Mpex reported that clinically and statistically significant improvements versus placebo were also seen in a number of important clinical endpoints, including FEV1, % predicted FEV1, FEF25-75 (all measures of respiratory function) and time to need for anti-pseudomonal antibiotics (a measure of exacerbations). Aeroquin is a proprietary formulation of levofloxacin that has been optimized for aerosol delivery using a customized Investigational eFlow Nebulizer System. Levofloxacin is a fluoroquinolone antibiotic that has been widely used in a variety of indications for over a decade and has established safety and efficacy when administered orally or intravenously against many bacterial pathogens, including P. aeruginosa. Administration of Aeroquin with a high efficiency nebulizer to the lungs allows for the rapid delivery of high concentrations of active drug directly to the site of infection, while minimizing systemic exposure.

About the Investigational eFlow Nebulizer System and eFlow Technology

Aeroquin is delivered via an Investigational eFlow Nebulizer System that has been optimized specifically for Aeroquin. Investigational eFlow Nebulizer Systems use eFlow Technology to enable highly efficient aerosolization of medication via a vibrating, perforated membrane that includes thousands of small holes producing the aerosol mist. Compared to other nebulization technologies, eFlow Technology produces aerosols with a very high density of active drug, a precisely defined droplet size, and a high proportion of respirable droplets delivered in the shortest possible period of time. Combined with its quiet mode of operation, small size (it fits in the palm of the patient's hand), light weight, and battery use, eFlow Technology reduces the burden of taking daily, inhaled treatments. The Investigational eFlow Nebulizer System and eFlow Technology are proprietary to PARI Pharma.

About Cystic Fibrosis

CF is a chronic, debilitating genetic disease. A major characteristic of CF is production of abnormally thick, sticky mucus in the lungs, trapping bacteria and predisposing patients to lung infections, which continually damage their lungs.

Pulmonary infection with Gram-negative bacteria, particularly pulmonary P. aeruginosa, represents the single greatest cause of morbidity and mortality among CF patients. Currently there is no known cure for CF, and the goal of CF therapy is to control symptoms and prevent further lung damage.

About PARI Pharma

PARI Pharma focuses on the development of aerosol delivery devices and comprehensive inhalation drug development to advance aerosol therapies where drug and device can be optimized together. Based on PARI's 100-year history working with aerosols, PARI Pharma develops treatments for pulmonary and nasal administration customized with advanced delivery platforms, such as eFlow (lower respiratory) and Vibrent (upper respiratory) Technologies. PARI Pharma partners with pharmaceutical companies to develop new or improved therapies. PARI Pharma has several clinical development programs ongoing, either partnered or on its own, for cystic fibrosis, asthma, COPD, respiratory syncytial virus (RSV) infection, and treatments for lung transplant patients among other indications. PARI Pharma, a PARI Medical Holding company, is located in Munich, Germany with a major presence in the United States.

Source: PARI Pharma