Safety Study of HemaMax™ (rHuIL-12) to Treat Acute Radiation Syndrome

This is a phase 2 single dose, randomized, double-blind, placebo-controlled, multi center
study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HemaMax™
(rHuIL-12) in healthy adult male and female subjects considered representative of U.S.
population.

Inclusion Criteria:

Male and Female healthy subjects who have signed the informed consent form must meet all of
the following criteria

- ≥18 to ≤75 years of age

- Body mass index (BMI) ≥ 18 and ≤ 35 kg/m2

- Normal ECG, vital signs and laboratory test results

- Use of effective birth control method and abstinence from sex

- Negative pregnancy test and drug screen

Exclusion Criteria:

Subjects with any of the following characteristics will be considered ineligible:

- History of clinically significant renal, hepatic pulmonary, cardiovascular,
cerebrovascular, gastrointestinal, metabolic, hematological, endocrine, urological,
immunological, neurologic or psychiatric disorders or connective tissue disease

- Positive for human immunodeficiency virus (HIV), Hepatitis B, or surface antigen
(HBsAg) or Hepatitis C antibody, tuberculosis (TB)

- Drug or alcohol addiction

- History of clinically significant allergy of any kind

- Prior use of IL-12 or HemaMax

- Use of any approved or investigational biologic agents or vaccinations of any kind in
last 3 months