Study Using Xolair in Rush Multi Oral Immunotherapy in Multi Food Allergic Patients

We will enroll multi food allergic participants (4-55 years of age) with proven "multi food
allergies". We anticipate enrolling 60 participants with allergies to, at least two foods.
Participants must have food specific IgE>4kU/L for each allergen or a skin test reactivity to
each food allergen ≥ 6 mm wheal diameter. We have chosen criteria associated with a very low
likelihood of natural loss of food allergy for the duration of this protocol. These values of
specific IgE and SPT were chosen based on the opinions of 4 experts. Participants also must
have a total IgE <1500kU/L, a clinical reaction during a double blind placebo controlled food
challenge (DBPCFC) with food proteins/powders to establish sensitivity to given food
proteins/powders (milk, egg, peanut, almond, wheat, cashew, sesame seed, soy, walnut,
hazelnut) and no clinical reaction during placebo (oat) as per CMC section of IND.

Participants will undergo a rush desensitization day at week 8 to a maximum dose of 1,250 mg
total protein. Participants will be ingesting either 2 to 5 food allergens, depending on
their allergy screening. They will consume home doses for two weeks based on the these
results and document reactions. Upon returning to the CFRU (Clinical Food Research Unit) two
weeks later, a dose escalation will be attempted. This cycle will continue until the
participant reaches a maximum dose of 2,000 mg protein daily of each food allergen (two to
five food allergens to be ingested by the participant). No more than 5 allergens will be
given.

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

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

- ImmunoCAP IgE level >4kU/L 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 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 >1,500 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 beta-blockers (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 OIT 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,
non-traditional forms of allergen immunotherapy (e.g., oral or sublingual)

- Severe asthma (2007 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:

- FEV1 < 80% of predicted, or FEV1/FVC < 75%, with or without controller
medications (only for age 6 or greater and able to do spirometry) or

- 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 (IV, 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 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.