A Phase 1 Study to Evaluate the Immunologic Mechanisms Underlying Wart Resolution After Intralesional Immunotherapy With Candida Antigen

Inclusion Criteria:

- Subjects must be ages 18-50.

- Female subjects of child-bearing potential must have a negative urine pregnancy test
before each treatment.

- Female subjects of child-bearing potential agree to use a reliable form of birth-
control as the risks associated with candida antigens during pregnancy are not known.

- Subjects must have two or more cutaneous, non-genital, non-facial warts.

- Subjects must be able to provide written, informed consent.

- Subjects must be willing to comply with the requirements of the protocol.

- Subjects vital signs must be within the following parameters at time of enrollment:

- Blood Pressure - <150/95 mmHg

- Temperature - <100.4° F

- Pulse Rate - 50 to 100 beats/minute

- Respiratory Rate - <24 breaths/minute

Exclusion Criteria:

- Subjects who have a history of disease or treatment that has caused the subject to be
immunosuppressed to include, but not limited to, cancer, HIV, or organ
transplantation. Immunosuppression will be determined only by medical history.

- Subjects who are pregnant, lactating, or attempting to become pregnant, as the risks
associated with candida antigens during pregnancy are not known.

- Subjects who have only genital or facial warts.

- Subjects who are unable to return for follow-up visits or comply with the protocol.

- Subjects who have a known allergy to Thimerosol or the candida antigen.

- Subjects who have a history of asthma as determined by a medical history or
treatment for an asthmatic episode.

- Subjects who have any type of diabetes.

- Subjects who are currently using non-selective Beta Blockers.

- Subjects who are currently using H2 antagonists (e.g., cimetidine). There will be a
24 hour washout period for any use of H2 antagonists prior to beginning treatment in
the study.

- Subjects who have a history of keloid formation.

- Subjects who have a history of alcohol or illicit drug abuse, as determined only by
medical history.

- Subjects who have had previous treatment with candida antigens for their warts.

- Subjects who are currently using any other treatments for their warts. This includes
prescription or over-the-counter medications. Subjects must have a wash¬out period of
30 days for any previous treatments prior to beginning the study.

- Subjects with a blood pressure >150/95, temperature >100.4° F, pulse rate <50 or >100
beats per minute, and respiratory rate >24 at time of enrollment.