Study of Inhaled RNS60 in Combination With Budesonide to Treat Mild to Moderate Asthma

Inclusion Criteria:

- Male or female non-smokers, aged between 18 and 65 years.

- Clinical diagnosis of mild to moderate asthma meeting NHLBI 2007 guidelines as
outlined in Appendix A.

- Subjects who have a currently prescribed inhaled corticosteroid medication to treat
asthma, alone or in combination with other medications, with usage of 1 month (≥ 95%
compliance) or more on the inhaled corticosteroid treatment.

- Normal 12-lead ECG at Screening.

- Normal single view chest x-ray at Screening.

- Men and women of reproductive potential who commit to use adequate contraception
during the study and for 1 month following the last day of treatment (Day 57).

- Women of childbearing potential who have a negative pregnancy test (serum HCG) at the
time of study entry, and again on Day 22.

- Subjects, or their legal guardians, must be capable of understanding the purpose and
risks of the study and provide written, voluntary, informed consent.

Exclusion Criteria:

- Chronic or acute disease that might interfere with the evaluation of RNS60.

- Pregnancy, intent to become pregnant, or breastfeeding.

- Current or prior malignancies (excluding non-melanoma skin carcinoma or in situ
carcinoma of the cervix that has been adequately treated).

- Positive viral serology test for Human Immunodeficiency Virus (HIV-1), HBsAG and
Hepatitis C antibody.

- Positive urine drug screen (UDS) for drugs of abuse including alcohol and cotinine at
the time of study entry and again on Day 22.

- Infections that require intravenous antibiotic therapy.

- Significant organ dysfunction, including cardiac, renal, liver, central nervous
system, pulmonary, vascular, gastrointestinal, endocrine, or metabolic (e.g.,
creatinine ≥ 1.6 mg/dL; ALT or AST ≥ 1.5x the upper limit of normal), history of
myocardial infarction, congestive heart failure, or arrhythmias within 6 months prior
to study entry.

- Treatment with a humanized or chimeric antibody therapy within 4 weeks prior to study
entry.

- Treatment with any investigational drugs, therapies, or medical devices within 4
weeks prior to study entry.

- Any use of antidepressants or other psychiatric medicine within 4 weeks prior to
study entry and/or during the study treatment period.

- Use of any over-the-counter asthma treatments, including Primatene Mist, during the
8-week active study period.