Multi Immunotherapy to Test Tolerance and Xolair

The investigators will enroll multi food allergic subjects (4-55 years of age) with proven
multi food allergies. The investigators anticipate enrolling 70 subjects with multi food
allergies at more than one site. Subjects must have food specific Immunoglobulin E >4 kilo
Units/Liter for each allergen or a skin test reactivity to each food allergen greater than or
equal to 6mm wheal diameter. In addition, subjects must have a total Immunoglobulin E <2,000
kilo Units/Liter, a clinical reaction during a double blind placebo controlled food challenge
(DBPCFC) with food protein/powder to establish sensitivity to given food protein/powder
(pecan, milk, egg, peanut, almond, wheat, cashew, sesame seed, soy, walnut, hazelnut, shrimp,
cod, salmon) and no clinical reaction during placebo (oat) as per Chemistry Manufacturing and
Control section of Investigational New Drug.

Each subject is planned to be enrolled in the active phase of the study for 36 weeks.

Food protein and powder will be obtained and prepared as per Investigational New Drug 14831
and will be in compliance with all applicable regulations.

Omalizumab is approved by the European Medicines Agency (European FDA) for patients with
severe asthma >6 years of age, and by the US FDA for patients >12 years of age. Omalizumab
will be dosed according to Genentech Dosing Omalizumab will be provided by the site.

Inclusion Criteria:

- Participant and/or parent guardian must be able to understand and provide informed
consent and/or assent as applicable.

- Age 4 to 55 years with moderate to severe allergy to milk and/or egg and/or peanut
and/or almond and/or wheat and/or cashew and/or sesame seed and/or soy and/or pecan
and/or walnut and/or hazelnut

- Positive skin prick test result greater than or equal to 6 mm wheal diameter to each
allergen OR

- ImmunoCAP Immunoglobulin E (IgE) level >4 kilo Unit/Liter for each allergen and

- A clinical reaction during a DBPCFC to small doses of food defined as < dose of 500 mg
food protein

- No clinical reaction observed during the placebo (oat) challenge and

- If female, must have a negative urine pregnancy test on the same day (using a Clinical
Laboratory Improvement Amendment (CLIA) approved urine test)

- If female, of child-bearing potential, must agree to be compliant with a
medically-approved method of contraception (please see Pregnancy section under Patient
Disposition in this protocol)

- Plan to remain in the study area of the research center during the trial

- Be trained on the proper use of the Epinephrine autoinjector

- Avoid open or blinded food challenges to other allergens outside this study

Exclusion Criteria:

- Inability or unwillingness of a participant/parent/guardian to give written informed
consent or comply with study protocol

- History of cardiovascular disease

- History of other chronic disease (other than asthma, atopic dermatitis, or rhinitis)
requiring therapy (e.g., heart disease, diabetes) that, in the opinion of the
Principal Investigator, would represent a risk to the participant's health or safety
in this study or the participant's ability to comply with the study protocol

- A total IgE at screening of >2,000 kU/L

- Previous adverse reaction to Xolair

- A history of severe anaphylaxis (defined as requiring intubation or admission to an
ICU) to food allergens that will be used in this study

- Unstable angina, significant arrhythmia, uncontrolled hypertension, current smokers,
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 participant.

- Current use of oral, intramuscular, or intravenous corticosteroids, tricyclic
antidepressants, or betablockers (oral or topical)

- Routine use of medication that could induce adverse gastrointestinal reactions during
the study

- Refusing to sign the Epinephrine autoinjector Training Form

- Pregnant or breast feeding women

- A history of oat allergy (since oat is the placebo agent in the DBPCFC), or an
objective reaction to the screening DBPCFC to oat

- Unwilling to avoid all food allergen-containing items except those given as part of
the Oral Immunotherapy as well as any other food allergens you are allergic to that
are not included in the 10 foods listed in the study

- Concurrent/prior use of immunomodulatory therapy (within 1 month) ie, omalizumab,
nontraditional forms of allergen immunotherapy (e.g., oral or sublingual)

- Severe asthma (2007 National Heart Lung and Blood Institute (NHLBI) Criteria Steps 5
or 6) at time of enrollment

- Mild or moderate asthma (2007 NHLBI Criteria Steps 1-4) at time of enrollment with any
of the following criteria met:

- Forced Expiratory Volume at one second (FEV1) < 80% of predicted, or FEV1/Forced Vital
Capacity (FVC) < 75%, with or without controller medications (only for age 6 or
greater and able to do spirometry) or

- Inhaled Corticosteroid (ICS) dosing of > 220 mcg daily fluticasone (or equivalent
inhaled corticosteroids based on NHLBI dosing chart) or

- 1 hospitalization in the past year for asthma or ER visit for asthma within the past
six months

- Use of steroid medications (Intravenous (IV), Intramuscular (IM) or oral) in the
following manners

- history of daily oral steroid dosing for >1 month during the past year or

- steroid burst course ( 5 or more days) of 1 mg/kg prednisone) course in the past 3
months or

- >2 steroid burst courses in the past year

- Use of complementary and alternative medicine (CAM) treatment modalities (e.g., herbal
remedies) for atopic and/or non-atopic disease within 90 days preceding rush
desensitization at week 8or at any time .

- Inability to discontinue antihistamines for the initial day of escalation, skin
testing or Oral Food Challenges (OFCs)

- Use of investigational drugs within 24 weeks of participation

- Past or current medical problems or findings from physical assessment or laboratory
testing that are not listed above, which, in the opinion of the investigator, may pose
additional risks from participation in the study, may interfere with the participant's
ability to comply with study requirements or that may impact the quality or
interpretation of the data obtained from the study.