A Phase 2 Randomized, Controlled, Blinded Study Omalizumab With Oral Food Immunotherapy in Children and Adults With Multiple Food Allergies

Our phase 1 study results show that multiple oral immunotherapy given in the same method
with omalizumab can be safe and show trends towards efficacy (attachment 3). Therefore, a
phase 2 randomized, controlled, blinded study has been proposed to further test safety and
efficacy in a larger group of subjects.

Inclusion Criteria:

- 1.Moderate to severe peanut and/or egg and/or milk and/or tree nut and/or seed
allergic subjects between the ages of 4 to 55 years old.

2.Sensitivity to food allergen will be documented by a positive skin prick test
result (see Appendix for details) or allergen-specific ImmunoCAP IgE level, with 7
kU/L as a lower limit of eligibility.

3.Sensitivity to food allergen based on a double-blind, placebo-controlled, oral food
challenge (DBPCFC), at maximum of cumulative 182.7 mg of food allergen protein dose
(see Appendix for details).

4.All female subjects of child-bearing potential will be required to provide a human
chorionic gonadotropin urine sample for pregnancy testing that must be negative 48
hours before being allowed to participate in the study.

5.Subjects must plan to remain in the study area during the trial. 6.Subjects must be
trained on the proper use of the EpiPen (see Appendix) to be allowed to enroll in the
study.

7.All female subjects of child-bearing potential must be compliant with a
medically-approved method of contraception (please see Pregnancy section under
Patient Disposition in this IND document)

Exclusion Criteria:

- No absolute contraindications are known. However, the risk of serious systemic
anaphylactic reactions to food allergens suggests a number of preexisting conditions
that should be considered relative contraindications. Among those conditions are
acute infections, autoimmune disease, severe cardiac disease, and treatment with
beta-adrenergic antagonistic drugs (beta-blockers).

1. Subjects with a total IgE at screening of >2,000 kU/L

2. Previous reaction to omalizumab

3. Subjects having a history of severe anaphylaxis to food allergens that will be
desensitized in this study requiring intubation or admission to an ICU, frequent
allergic or non-allergic urticaria, or history consistent with poorly controlled
persistent asthma.

4. Subjects with unstable angina, significant arrhythmia, uncontrolled
hypertension, chronic sinusitis, or other chronic or immunological diseases
that, in the judgment of the investigator, might interfere with the evaluation
or administration of the test drug or pose additional risk to the subject (e.g.,
gastrointestinal or gastroesophageal disease, chronic infections, scleroderma,
hepatic and gallbladder disease, chronic non-allergic pulmonary disease).

5. Subjects with an FEV1 or PEF less than 80% predicted (moderate persistent
asthma) with or without controller medication (if able to perform the maneuver)
at screening, an oral desensitization visit, or a food challenge visit.

6. Subjects who are current users of oral, intramuscular, or intravenous
corticosteroids, tricyclic antidepressants, or are taking a beta-blocker (oral
or topical).

7. Subjects routinely using medication that could induce adverse gastrointestinal
reactions during the study.

8. Subjects refusing to sign the EpiPen Training Form (see Appendix).

9. Women who are pregnant or breast feeding.

10. Subjects with a history of oat allergy (since oat is the placebo agent in the
DBPCFC, as per IND 14477) .

11. Subjects with other food allergies must agree to eliminate these other food
items from their diet so as not to confound the safety and efficacy data from
the study.

12. Subjects with a diagnosis of eosinophilic esophagitis, eosinophilic colitis, or
eosinophilic gastritis.