Patient enrollment is underway for a Phase 3 study evaluating Soligenix's (OTC:SNGX) SGX301, a treatment for cutaneous T-cell lymphoma (CTCL).
SGX301 has previously been granted both orphan drug and fast track designations from the US Food and Drug Administration (FDA) for the first-line treatment of CTCL, a rare disease and a class of non-Hodgkin's lymphoma, a type of cancer of the white blood cells that are an integral part of the immune system.
The Phase 3 study will be a multi-center, randomized, double-blind, placebo-controlled one, and Soligenix is looking to enroll 120 subjects.
The primary efficacy endpoint will be assessed on the percentage of patients in each of the two treatment groups (i.e., those taking SGX301 and those the placebo) achieving a partial or complete response of the treated lesions, defined as a greater-than-50% reduction in the total composite assessment of index lesion disease severity (CAILS) score for three index lesions at the Cycle 1 evaluation point (week 8) compared to the total CAILS score at baseline, Soligenix revealed.
Other secondary measures will assess treatment response (including duration), degree of improvement, time to relapse and safety. The study is anticipated to complete enrollment with primary data available in the second half of 2016.
Alain Rook, MD, director of the Cutaneous Lymphoma Program at the Hospital of Pennsylvania, has been working closely with Soligenix on the Phase 3 program and said: “I believe that SGX301 has the potential to be a major step forward in the treatment of CTCL by providing a safer alternative therapy over the course of the patients' disease than is currently available.”