Soligenix has received a positive recommendation from the independent Data Monitoring Committee (DMC) to continue enrolling into the company's Phase 3 "Fluorescent Light Activated Synthetic Hypericin" (FLASH) study for SGX301 (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (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.
"We are pleased to have received the DMC's recommendation to continue enrolling to the adjusted target of 160 evaluable subjects in order to maintain our conservative power calculation," said Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We have invested a significant amount of the Company's resources over the last three years into the CTCL development program and it is gratifying to have received this feedback from the DMC indicating sufficient potential efficacy to warrant enrolling additional subjects into the trial. With this new level of clarity from the DMC's analysis of the interim Phase 3 study data and given our current enrollment status of approximately 120 subjects, we anticipate completing the study before the end of 2019 with topline results coming no later than the first quarter of 2020. Given our current cash resources, we anticipate that the available funds are sufficient to cover the additional study patients needed. We believe SGX301 has the potential to be a valuable therapy in the treatment of early stage CTCL, which is an orphan disease and area of unmet medical need."
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"The DMC's recommendation is very encouraging and will allow us to aggressively pursue completing the trial, demonstrating SGX301's potential to successfully treat the CTCL index lesions using a combination therapy (SGX301 and the proprietary fluorescent light panel) that minimizes the long-term risks of treatment-associated secondary cancers," said Richard Straube, MD, Senior Vice President and Chief Medical Officer of Soligenix. "SGX301 truly has the potential to have a significant impact on the lives of CTCL patients. We would like to thank the DMC members for their assistance, as well as our esteemed medical advisory board and our dedicated clinical investigators for their ongoing efforts in the design and conduct of this important clinical trial."
Based on the positive results demonstrated in the Phase 2 study of SGX301, the pivotal Phase 3 protocol is a highly powered, double-blind, randomized, placebo-controlled, multicenter trial originally targeted to enroll 120 evaluable 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 (0.25% synthetic hypericin) 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 (i.e., SGX301 and placebo) achieving a successful response of the treated lesions, defined as an overall ≥50% reduction as assessed by the Composite Assessment of Index Lesion Severity (CAILS) scoring system across the three index lesions at the Cycle 1 evaluation visit (week 8) compared to the total CAILS score at baseline. Other secondary measures assessed are treatment response (including duration), degree of improvement, time to relapse and safety.