Efficacy, Safety and Tolerability Study of SHAPE in IA, IB or IIA Cutaneous T-cell Lymphoma

This is a Phase 2, multicenter, open-label, randomized study to evaluate the efficacy and
safety of SHAPE Gelled Solution applied topically daily or twice daily for 26 consecutive
weeks to specified skin lesions in patients with Stage IA, IB or IIA CTCL. Patients
responding to treatment will be allowed to continue on study for a maximum of 52 weeks.

Inclusion Criteria:

- Histological confirmation of CTCL; a documented verifiable biopsy report is required

- Documented clinical stage IA, IB or IIA CTCL

- Skin lesion involvement of at least 2% of BSA accessible for topical application of
study drug

- ECOG performance status of 0-2

Exclusion Criteria:

- CTCL with histologic evidence of folliculotropic variant or large cell transformed
CTCL

- Palpable lymph node ≥1.5 cm in diameter (unless the lymph node has been biopsied and
designated as Stage IA-IIA disease)

- Co-existent second malignancy or history of prior solid organ malignancy within
previous 5 years (excluding basal or squamous cell carcinoma, in situ carcinoma of
the cervix (CIN3), papillary or follicular thyroid cancer or prostate cancer that has
been treated curatively

- Any prior history of hematologic malignancy (other than CTCL) within past 5 years

- CTCL disease that is known to be refractory to systemic histone deacetylase
inhibitors

- Prior or concurrent central nervous system (CNS) metastases

- History of or current major gastrointestinal, pulmonary, cardiovascular,
genitourinary or hematologic disease, CNS disorders, infectious disease or
coagulation disorders as determined by the Investigator

- Evidence of active Hepatitis B or C or HIV

- Circulating atypical cells of clinical significance