PARI Pharma commences enrollment in L-CsA Phase 2b efficacy study

Feb 11 2010

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.