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PARI Pharma Reports Successful Phase Ib Clinical Results for Inhaled Liposomal Cyclosporine A and Gains FDA Orphan Drug Designation for the Prevention and Treatment of Bronchiolitis Obliterans
Date:6/2/2009

MONTEREY, Calif., June 2 /PRNewswire/ -- This month's Journal of Aerosol Medicine and Pulmonary Drug Delivery features positive Phase Ib clinical trial results for PARI Pharma's L-CsA, inhaled liposomal cyclosporine A. In May, PARI Pharma received Orphan Drug Designation from the Food and Drug Administration for L-CsA, delivered via an Investigational eFlow Nebulizer System, for the prevention and treatment of bronchiolitis obliterans, a devastating, incurable disease of the small airways affecting approximately 60,000 patients worldwide.

"PARI's encouraging results show that it is feasible and well tolerated to deposit relevant amounts of L-CsA into transplanted lungs. This has the potential to prevent and treat bronchiolitis obliterans in a more efficient way compared to current oral standard treatment. Inhaled L-CsA has a favorable drug distribution to the target sites in the lung, which should lead to lower side effects than associated with systemic cyclosporine exposure," stated Prof. Jurgen Behr, head of the Division of Respiratory Disease at the Ludwig Maximilians University, Klinikum Grosshadern, Munich, Germany.

"The long-term survival rate for lung transplant patients could be greatly improved through an effective inhaled liposomal cyclosporine therapy. Using our proprietary liposomal technology we created an inhaled formulation that is free from irritating solvents and optimized for administration via an Investigational eFlow Nebulizer System without destroying the liposome," stated Dr. Manfred Keller, executive vice president and chief scientific officer of PARI Pharma GmbH. "We had a very encouraging pre-IND meeting with the FDA, and their recent Orphan Drug Designation for L-CsA, which follows a similar designation in Europe, encourages us to move forward to solve this unmet medical need."

PARI Pharma's Phase Ib clinical trial for L-CsA studied 12 lung transplant recipients, where five patie
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