Soligenix receives DMC recommendation to enroll more subjects in FLASH study
Soligenix announced it has received a recommendation from the independent data monitoring committee, or DMC, to continue enrolling into the company's Phase 3 Fluorescent Light Activated Synthetic Hypericin, or FLASH, study for SGX301 in the treatment of cutaneous T-cell lymphoma, or CTCL. Following its unblinded interim analysis with data from approximately 100 subjects, including assessment of the study's primary efficacy endpoint, the DMC recommended that approximately 40 additional subjects be randomized into the trial to maintain the rigorous assumption of 90% statistical power for the primary efficacy endpoint. No safety concerns were reported by the DMC based on the interim analysis. Based on the positive results demonstrated in the Phase 2 study of SGX301, the pivotal Phase 3 protocol is a double-blind, randomized, placebo-controlled, multicenter trial originally targeted to enroll 120 subjects. The trial consists of three treatment cycles, each of 8 weeks duration. Treatments are administered twice weekly for the first 6 weeks and treatment response is determined at the end of week 8. In the first treatment cycle, approximately two-thirds of the subjects receive SGX301 and one-third of the subjects receive placebo treatment of their index lesions. In the second cycle, all subjects receive SGX301 treatment of their index lesions and in the optional third cycle all subjects receive SGX301 treatment of all their lesions. Subjects are followed for an additional 6 months after the completion of treatment. The primary efficacy endpoint is assessed on the percent of patients in each of the two treatment groups achieving a successful response of the treated lesions, defined as an overall 50% reduction as assessed by the Composite Assessment of Index Lesion Severity, or CAILS, scoring system across the three index lesions at the cycle 1 evaluation visit compared to the total CAILS score at baseline. Other secondary measures assessed are treatment response degree of improvement, time to relapse and safety.