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Discovery Labs Presents Surfaxin and Aerosurf Data At the Pediatric,Academic Societies' Annual Meeting

ough 36 weeks post-menstrual age (PMA), and

* fewer days on mechanical ventilation.

Dr. Bose commented, "The data from this Phase 2 estimation trial are encouraging. These data support the continued evaluation of Surfaxin as a therapeutic option for the prevention of BPD."

Discovery's Phase 2 clinical trial enrolled 136 premature infants. In addition to standard of care, patients were randomized to receive either Surfaxin standard dose (175 mg/kg), Surfaxin low dose (90 mg/kg), or sham air as a control. The trial was designed as an estimation study to evaluate the safety and potential efficacy of Surfaxin in infants at risk for BPD, and was not powered to determine statistically significant differences in outcomes. The Surfaxin standard dose (175 mg/kg) is the dose that was administered in Discovery's RDS Phase 3 clinical trials. No meaningful conclusions could be drawn from the Surfaxin low dose (90 mg/kg) treatment group, as infants randomized to this arm had more pre-existing medical risk factors compared with the Surfaxin standard dose (175 mg/kg) group and the control group.

Aerosurf(tm) (aerosolized KL-4 surfactant) delivered via the Chrysalis Technologies novel capillary aerosol generator device

Data from previously conducted pre-clinical studies using aerosolized KL-4 surfactant were also presented to the medical community for the first time. In these studies, KL-4 surfactant was aerosolized to compare Chrysalis' novel, investigational capillary aerosol generator technology to commercially available aerosol generator devices. The studies demonstrated that Aerosurf maintains its chemical structure and essential functional activity post-aerosolization. In addition, the Chrysalis investigational capillary aerosol generator technology generated a nearly 10-fold higher aerosol output rate than the other study devices.

Discovery Labs, in collaboration with Chrysalis, is developing an integrated drug device system that comb
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