Since PRs tend to disappear, here is the main part
Press Release Source: Discovery Laboratories
New Data Shows Discovery's Surfaxin Survival Benefit Continues Through One Year of Life
Wednesday May 18, 7:30 am ET
Data Presented as a Late-Breaker at the 2005 Pediatric Academic Societies' Annual Meeting
WARRINGTON, Pa., May 18, 2005 (PRIMEZONE) -- Discovery Laboratories, Inc. (NasdaqNM:DSCO - News), announced that additional long-term clinical data from their two Surfaxin(r) (lucinactant) Phase 3 clinical trials to treat Respiratory Distress Syndrome (RDS) in premature infants, SELECT and STAR, were presented by Fernando Moya, M.D., Chair of the SELECT study Steering Committee, as a late-breaker presentation at the Pediatric Academic Societies' Annual Meeting held in Washington D.C. In his presentation, Dr. Moya reported that premature infants treated with Surfaxin experienced a survival benefit through one year of life, corrected age compared to those treated with the currently available animal-derived surfactants (Survanta(r) and Curosurf(r)). These findings build upon the statistically significant pooled data that was presented at the December 2004 Hot Topics in Neonatology Meeting, which demonstrated that premature infants treated with Surfaxin experienced a survival benefit at 36 weeks post-menstrual age versus animal-derived surfactants.
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The additional long-term clinical data were derived from a pooled analysis that combined data from the SELECT and STAR trials. This analysis was performed to determine the long-term outcomes including mortality and morbidity at one year of life, corrected age for Surfaxin versus the leading animal-derived surfactants, Survanta and Curosurf. The pooled Surfaxin data showed significantly (p=0.05) improved survival compared to the combined data from the two animal-derived surfactants (Survanta and Curosurf).
``The long-term outcomes from the pooled analysis are particularly important because they suggest that a next-generation surfactant therapy, such as Surfaxin, may save more babies' lives while improving their chances for a healthy future,'' said Fernando Moya, M.D., Chair of the SELECT study Steering Committee and Richard W. Mithoff, Professor of Neonatal-Perinatal Medicine, Department of Pediatrics UT-Houston School of Medicine. ``Premature infants are a population with uncertain long-term outcomes. Any additional long-term benefits that can be achieved while increasing their odds for survival, such as reduced complications associated with BPD, represent a significant advancement in neonatal care.''
Surfaxin is a precision-engineered, peptide-containing, synthetic surfactant that is designed to closely mimic the function of natural human lung surfactant and represents a potential alternative for the animal-derived and non-protein containing synthetic surfactants. Discovery's Surfaxin has recently received an Approvable Letter from the United States Food and Drug Administration (FDA) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants and is pending approval.
At the same medical congress, Dr. Melpo Christofidou-Solomidou, from the University of Pennsylvania Department of Medicine, Pulmonary, Allergy and Critical Care Division, presented a preclinical study indicating that KL-4 surfactant (Surfaxin) provides a unique anti-inflammatory benefit relative to Survanta, the current U.S. market leader. |
