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PARI Pharma Enrolls First Patient in Phase 2b Study of L-CsA
Date:2/11/2010

MONTEREY, Calif., Feb. 11 /PRNewswire/ -- PARI Pharma has enrolled the first patient in its Phase 2b clinical trial studying inhaled liposomal cyclosporine A (L-CsA) delivered via a customized Investigational eFlow Nebulizer System.  The multinational study is investigating the safety and efficacy of PARI's L-CsA formulation. In previous clinical trials, reactions from physicians and lung transplant recipients to PARI's drug-device combination were encouraging.

"We are very pleased to move forward with this investigational treatment aimed at preventing bronchiolitis obliterans, which is an incurable small airway disease in lung transplant recipients.  This study has been designed with advice from the European Medicines Agency under L-CsA's orphan drug designation status," said Manfred Keller, chief scientific officer and executive vice president of PARI Pharma.

PARI Pharma's Phase 2b trial is a multi-center, randomized, double-blind, placebo controlled, parallel group, dose-finding study to investigate the safety and efficacy of L-CsA in doses of 10mg/day and 20mg/day to prevent bronchiolitis obliterans in recipients of lung transplants.

"We are seeing early success from our L-CsA program. This underscores PARI Pharma's unique position to combine formulation expertise with our advanced aerosol delivery technology to develop best in class therapies for unmet medical needs," added Martin Knoch, president of PARI Pharma.

Positive data regarding human lung deposition and distribution of L-CsA was published in the Journal of Aerosol Medicine and Pulmonary Drug Delivery last year, and clinical as well as preclinical data will be presented in April at the Annual Meeting of the International Society of Heart and Lung Transplantation in Chicago.

About PARI Pharma's Inhaled L-CsA Formulation

PARI Pharma's L-CsA is a low-dose, well-tolerated, inhaled, liposomal cyclosporine A formulation that aims to improve both the pharmacological and pharmacokinetic profile compared to an oral or systemic CsA immuno-suppression therapy.  Systemic therapy is associated with low and highly variable bioavailability, poor drug distribution to the target site in the lungs and airways, severe side effects, such as kidney and brain damage, and vulnerability to infections.

L-CsA is an investigational, proprietary, liposomal formulation of 10mg CsA/2.5mL for inhalation delivery via a customized Investigational eFlow Nebulizer System, both developed by PARI Pharma. The L-CsA formulation is comprised of an artificial lung surfactant carrier, free of any irritating organic solvents, and consists of unilamellar liposomes of about 100nm.  PARI's L-CsA is provided in a lyophilized format and reconstituted by saline 0.25% prior to administration.

About the Investigational eFlow Nebulizer System and eFlow Technology

L-CsA is delivered via PARI's Investigational eFlow Nebulizer System.  The Investigational eFlow Nebulizer System uses eFlow Technology to enable highly efficient aerosolization of liquid medications via a vibrating, perforated membrane that includes thousands of small holes that produce 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, products incorporating eFlow Technology reduce the burden of taking daily, inhaled treatments. The Investigational eFlow Nebulizer System and eFlow Technology are proprietary to PARI Pharma.

About Bronchiolitis Obliterans

According to the International Society of Heart and Lung Transplantation Registry, development of bronchiolitis obliterans is the single most important risk factor for mortality among lung transplant recipients. Bronchiolitis obliterans is an incurable small airways disease, which manifests as chronic allograft rejection and results in airflow obstruction. The disease is also a factor in other lung diseases such as collagen vascular diseases, inhalation of toxic fumes, and respiratory tract infections. Bronchiolitis obliterans affects approximately 60,000 patients worldwide, and once it develops, most patients die of respiratory failure within about 5 years.

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. More information is available at www.paripharma.com.

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