TetraLogic Reports Initiation of Randomized Phase 2 Trial of SHAPE for Cutaneous T-Cell Lymphoma

TetraLogic Pharmaceuticals Corporation

today announced the initiation of a randomized Phase 2 clinical trial of SHAPE in subjects with early stage cutaneous T‑cell lymphoma ("CTCL"). 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. "We are excited to advance our second molecule into a randomized Phase 2 trial," said J. Kevin Buchi, President and Chief Executive Officer of TetraLogic. "SHAPE's Phase 1 data suggests that it may provide significant clinical benefit over existing CTCL therapies, and we are hopeful that those data are replicated over a longer duration and a broader body surface area.