Optimum Dose of rhCC10 for Lung Protection in IRDS

DESCRIPTION (Scanned from the applicant's description): The proposed study involves an evaluation of the dose response to recombinant human CC10 in the preterm lamb, a surfactant-dependent model of neonatal/infant respiratory distress syndrome (IRDS). The preterm lamb model was used in the clinical development of artificial surfactants for the treatment of IRDS. CC10 is normally secreted by the Clara cells of the tracheal and bronchial epithelia of the mature lung. It is abundant in the extracellular fluids of the lungs and is a natural component of endogenous surfactant. Analogous to surfactant, CC10 is not present in the lungs of preterm babies. Preliminary results indicate that CC10 is, in fact, essential to normal lung function, and that a replacement strategy with rhCC10 may be effective in reducing pulmonary inflammation and incidence of chronic lung disease (CLD) in premature babies treated for respiratory distress. The safety of administration of high doses of rhCC10 has already been established in pre-clinical studies in newborn piglets. A controlled study to optimize the dose response for maximal lung protection and define the clinical parameters to measure efficacy of rhCC10, administered in conjunction with artificial surfactant, in a preterm surfactant dependent model of IRDS, is now proposed. PROPOSED COMMERCIAL APPLICATION: CC10 is currently in Phase I of clinical development of rhCC10 for the prevention of neonatal broncho-pulmonary dysplasia. This study is important in designing effective dosing strategies for further clinical development. According to recent estimates, approximately 90,000 premature babies are born in the U.S. each year. Of those, about 50,000 will have infant respiratory distress syndrome (IRDS) AND 20,000 of those babies with IRDs will develop BPD or some form of chronic lung disease. The annual cost of treating these babies in the first three months of life is about $200,000 each for an annual expense of a minimum of $4 billion. Many of these babies continue to have respiratory problems throughout childhood and the cost of this continued care have not been included in the $4 billion/year estimate. Recombinant human CC10 has the potential to prevent this disease and reduce the annual economic burden of caring for these children. RhCC10 may also be important in treating many pediatric and adult respiratory diseases as well.