A Phase 2 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis

Inclusion Criteria:

- Age greater than or equal to 18 years

- Onset of severe sepsis within the previous 24 hours

- Must be receiving antibiotic therapy

- Informed consent form signed by patient, legal next-of-kin or legal guardian

- Able to take medication by mouth or feeding tube

Exclusion Criteria:

- Receipt of investigational medication within 4 weeks prior to participation in the
study

- Pregnant or breast-feeding

- Severe congestive heart failure

- Known severe HIV infection

- Presence of severe burns

- Patients on high dose immunosuppressants

- Patients whose death is considered imminent

- Patients whose life expectancy for concurrent illness is less than 6 months

- Severe hypoxic encephalopathy or persistent vegetative state

- Severe liver disease

- Patient, legal representative or patient's primary physician not committed to
providing full, aggressive life support