Safety and Efficacy of Varying Regimens of CANDIN for Treatment of Common Warts (Verruca Vulgaris)

Inclusion Criteria:

1. Men or women between the ages of 18 and 65 years inclusively at time of consent

2. Subjects presenting with 3 to 20 injectable common warts (verruca vulgaris) for at
least 12 weeks at the time of the Baseline Visit

3. Subject's common warts for injection must measure between 3 and 20 mm at Baseline
Visit and be located on hands, feet (excluding soles), limbs, and/or trunk. Flat,
plantar, facial, periungual, genital warts or warts in region of pre-existing
inflammatory condition are excluded from injection

4. Subjects enrolled into Cohort 3 must have common warts for injection in at least 2
different anatomical regions defined as: left arm, right arm, left hand, right hand,
left leg, right leg, left foot (excluding sole), right foot (excluding sole) and
torso

5. Subject, male or female is willing to use effective contraceptive method for at least
30 days before the Baseline Visit and at least 30 days after the last study drug
administration unless not of childbearing potential as defined as post-menopausal for
at least 2 years (females) or surgically sterile (tubal ligation, oophorectomy, or
hysterectomy for females, and vasectomy for males). The only contraceptive use
exceptions would be individuals in exclusive same sex partnerships and individuals
who agree to remain non-sexually active for the duration of the study. Acceptable
contraceptive methods for subjects include:

- Barrier methods, such as condom, sponge or diaphragm, combined with spermicide
in foam, gel or cream;

- Hormonal contraception (oral, intramuscular, implant or transdermal which
includes Depo-Provera, Evra and Nuvaring);

- Intrauterine device (IUD)

6. Mentally and legally capable of giving informed consent prior to any study related
procedures

Exclusion Criteria:

1. Presence of systemic or localized diseases, conditions, or medications that could
interfere with assessment of safety and efficacy or that compromise immune function
including psoriasis

2. Subject has been diagnosed with diabetes mellitus

3. Subject has a history of keloid formation

4. Injectable common wart(s) located in areas with existing dermatologic conditions
(such as psoriasis) or with an underlying inflammatory conditions (such as arthritic
joints), or tattoos or implants/piercing/hardware or marking that may conceal
responses or reactions are excluded from injection

5. Existing/planned pregnancy, childbirth in the past six months prior to the Baseline
Visit, or breast feeding, or plan on donating eggs or sperm during the study and in
the month following the last injection

6. Treatment of warts with liquid nitrogen, carbon dioxide, electrodessication, laser,
surgery, simple occlusion (e.g. duct tape) salicylic or related acids, OTC
treatments, cantharidin, or other treatments within 4 weeks of the Baseline Visit

7. Treatment with immunotherapy (DPCP, DNCB or other), imiquimod, 5-fluorouracil,
bleomycin, podophyllin or any other wart immunotherapy or treatment designed to
stimulate immune response (except for treatments already listed in exclusion
criterion 6) within 12 weeks of the Baseline Visit

8. Recalcitrant warts defined as those not successfully treated by 5 or more treatments
(excluding OTC treatments)

9. Abnormal (low < 5 mm or high >25 mm) baseline result to the Delayed Type
Hypersensitivity (DTH) test

10. Subject has a condition or treatment resulting in being immunocompromised

11. Systemic treatment (such as oral or injected) with cimetidine, zinc supplements at a
dose higher than 20 mg of elemental zinc daily or an immunosuppressive drug (such as:
azathioprine, 6-mercaptopurine, methotrexate, infliximab, adalimumab, etanercept,
systemic steroids, etc.) within 12 weeks of the Baseline Visit

12. Subject has used any investigational agent within 30 days prior to the Baseline Visit
or within 5 half-lives of that investigational agent prior to the Baseline Visit
(whichever is longer)

13. Previous treatment of warts with any type of intralesional injection with candida
extract (including CANDIN)