To Determine the Maximum Tolerated Dose Level (MTD) of PEP005 Topical Gel in Patients With sBCC

Basal cell carcinomas (BCCs) are a common skin problem largely caused by long term sun
exposure. Current treatments include surgery, curettage/desiccation and simple excision,
which are often cosmetically disfiguring. Non-invasive alternative therapy for treatment of
BCC lesions is thus being researched. Sap from the plant Euphorbia peplus has been used for
many years in Australia as a "folk" remedy to treat a number of skin conditions. The active
component of Euphorbia peplus has been isolated and made into a gel applied directly to the
skin by Peplin Opeation Pty Ltd.

The proposed study follows a previously conducted 12 week study in sBCC, PEP005-003. This
was a two dose schedule evaluating doses up to 0.05%. Histological clearance rate at the end
of study was 71% for the 0.05% concentration on the Day 1, Day 2 schedule compared with 0%
in the vehicle group.

The proposed study aims to determine the maximum tolerated dose level (MTD) of PEP005
Topical Gel, in patients, when administered either as a single application or as two
applications to a selected superficial basal cell carcinoma lesion with a 3 month follow up.

1. Male or female patients at least 18 years of age.

2. A primary clinically diagnosed and histologically confirmed sBCC lesion located on
the trunk which is suitable for excision the histological diagnosis should be made no
more than 60 days prior to the screening visit the biopsy specimen should have
removed no more that 20% of the total tumour mass

3. Ability to follow study instructions and likely to complete all study requirements.

4. Written informed consent has been obtained.

5. Agreement from the patient to allow photographs of the selected lesion to be taken
and used as part of the study data package.