TetraLogic Pharmaceuticals Corporation announced the initiation of a randomized Phase 2 clinical trial of SHAPE in subjects with early stage cutaneous Tcell lymphoma. SHAPE has been evaluated in a randomized, dose escalation, placebo-controlled Phase 1 clinical trial in early-stage CTCL subjects that met safety endpoints and demonstrated clinical activity. Four of fifteen patients receiving SHAPE attained an objective response as measured by a greater than 50% improvement in their Composite Assessment of Index Lesion Severity, or CAILS, score during and after 28 days of dosing.

No placebo patients responded. The randomized Phase 2 trial will be conducted in approximately sixty subjects with Stage IA-IIA CTCL. The objectives of the Phase 2 clinical trial are to evaluate the dose, clinical effect at 6 months (based on CAILS score), time to response, and tolerability of treatment of >2% body surface area.