KL₄Surfactant Treatment in Patients With ARDS

This is a multinational, multicenter, two-part, Phase 2 study that will evaluate the
tolerability, safety, and efficacy of KL₄Surfactant in adult ARDS patients when administered
by sequential bronchoscopic lavage into each of the 19 bronchopulmonary segments of the lung
and as a bolus instillation into each lung.

Inclusion Criteria:

- Intubated and required mechanical ventilation support

- Met the criteria for ARDS

- Partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) ≤ 200 mmHg and ≥ 60
mmHg within 60 minutes before randomization

- Mean blood pressure was ≥ 60 mmHg immediately before randomization

Exclusion Criteria:

- Had ARDS due solely to a major trauma

- Was currently participating in another clinical trial or received an experimental drug
or device within the previous month

- A woman of childbearing age, unless pregnancy was excluded by a negative urine hCG
test or if the subject was surgically incapable of childbearing

- Had a previous episode of ARDS that resolved and then recurred during the current
hospitalization

- Had a disease that was sufficiently advanced, in the best judgment of the Principal
Investigator, to markedly limit life expectancy to < 6 months

- Was known to have AIDS or symptomatic HIV (CD4 counts <500). Subjects with
asymptomatic HIV were not excluded

- Received chemotherapy or radiation within the previous 90 days

- Received an organ transplant other than corneal transplants

- Received, or was currently receiving, immunosuppression therapy within the last 6
months

- Had severe neurological damage or the presence of a disease that was likely to
significantly prevent weaning from the ventilator

- Had a best Glasgow Coma Score (GCS) of ≤ 8 or an intracranial pressure ≥ 20 cm H2O
prior to the institution of sedatives or paralysis