Study of Tolerability and Efficacy of BVS857 in Severe Burn Subjects

No formal analysis was performed as study was terminated due to low enrollment issues. (n=1
patient was enrolled)

Inclusion Criteria:

- Burn injury comprising 2nd degree deep partial thickness and/or 3rd degree full
thickness burns, ≥20% total body surface area with expected need for surgical
intervention and not exceeding the sum of age plus burn size of 100 (Baux score)

- Dosing must occur within 8-12 days post-burn

- Subjects must weigh at least 45kgs (for group 1 with doses of 0.03mg/kg) and be under
100 kg to participate in the study

Exclusion Criteria:

- Spinal cord injury

- Hypoxic brain injury (Glasgow Coma Scale (GCS) <8) at screening

- True conductive electric burn with suspected neurologic injury

- Uncontrolled diabetes with HbA1c > 10% at screening, or known history of
hypoglycemia,

- History of or active peripheral neuropathy or seizure disorder

- Systemic corticosteroids : > 10mg/d of prednisone or equivalent, other
investigational treatments (excluding investigational dressings), medications for
weight loss including megestrol acetate, androgens or oral beta agonists