Study of SOR007 Ointment for Actinic Keratosis

In this Phase 2, randomized, double-blind, dose rising trial, subjects with actinic keratosis
will receive topical application of SOR007 Ointment (in four concentrations) or SOR007
Ointment vehicle to the face twice daily for up to 28 days. Subjects will be enrolled in four
dose-escalating cohorts of eight subjects and randomized to SOR0007 or Ointment vehicle in a
ratio of 3:1. Cohorts will be enrolled sequentially starting at the lowest concentration.

Safety will be assessed in an ongoing manner and formal safety reviews will be conducted four
times for each cohort: at Day 8, Day 15, Day 21, and Day 28 for the last subject enrolled in
each cohort. The next dose level cohort will enroll upon a finding of safety and tolerability
at the previous cohort's second (Day 15) safety review.

The safety and tolerability of SOR007 will be demonstrated by local toxicity, adverse events,
laboratory assessments and vital signs. Subjects will be observed for reduction in the number
of AK lesions to determine preliminary efficacy. Plasma samples will be taken at various time
points throughout the study to characterize the pharmacokinetics of SOR007.

Inclusion Criteria:

- Signed informed consent.

- Men and women with actinic keratosis.

- Age 45-85.

- Women who have had surgical sterilization or are post-menopausal (absence of menses
for at least one year) are eligible. Women of child-bearing potential who are
non-pregnant, non-nursing, and willing to avoid pregnancy during the course of the
study and during the menstrual cycle following completion of their participation in
the study are eligible. (Adequate contraception is defined as regular use of diaphragm
with condoms, IUD with condoms, or systemic contraceptives if used for at least three
months prior to enrollment in the study.) A negative pregnancy test is required as an
entry criteria. Women must continue to use the method of contraceptive for at least 30
days after the last administration of study drug.

- Male subjects must agree to sexual abstinence or use adequate contraception when
sexually active in combination with their female partners, if they are of childbearing
potential. That means the volunteer must be vasectomized or use a condom and his
female partner must either be surgically sterile (hysterectomy or tubal ligation) or
agree to use a reliable method of contraception with a failure rate of less than 1%
per year when used consistently and correctly such as implants, injectables, combined
oral contraceptives, or non-DalKon Shield IUDs. This applies from signing of informed
consent form until 90 days after the last study drug administration. Methods of
contraception must have been effective for at least 30 days on the day of signing of
informed consent. Male volunteers must also refrain from sperm donation from the time
of singing informed consent form until 90 days after the last study drug
administration.

- Presence of 4-8 AK lesions total in a 25 cm2 area identified on the face through
transparency mapping and photographs. The face area will be defined from hair line to
jaw line. The scalp will not be included. An imaginary normal hair line will be the
upper boundary for bald men.

- Able to refrain from the use of all other topical medications to the facial area
during the treatment period.

- Considered reliable and capable of understanding their responsibility and role in the
study.

Exclusion Criteria:

- History of allergy or hypersensitivity to paclitaxel.

- Lesions that are thicker than 1 mm or larger than 9 mm will not be included in the
lesion counts.

- Lesions suspicious for squamous cell carcinoma, basal cell carcinoma, or melanoma will
not be included in lesion counts and cannot be in the 25 cm2 area of treatment.

- Abnormal pre-existing dermatologic conditions which might affect the normal course of
the disease (e.g. albinism or chronic vesiculobullous disorders).

- Positive urine pregnancy test in women of child-bearing potential.

- Inability to use adequate birth control measures for men or women of child-bearing
potential, as defined above.

- Serious psychological illness.

- Significant history within the past year of alcohol or drug abuse.

- During the 30 day period preceding study entry: Participating in any clinical
research; using topical paclitaxel for AK; using any other topical agents including
but not limited to actinex, glycolic acid products, alpha-hydroxy acid products, and
chemical peeling agents for the treatment of AK; using any systemic steroids or
topical corticosteroids, having cryosurgery.

- Use of sun lamps or sun tanning beds or booths during the 2 weeks prior to first
application and until final visit.

- Prior treatment with systemic paclitaxel or systemic cancer therapy within 6 months of
study entry.

- Medical history which, based on the clinical judgment of the Investigator implied an
unlikelihood of successful completion of the study.