Soligenix completes enrollment in its pivotal phase 3 clinical trial of sgx301 in the treatment of cutaneous t-cell lymphoma

Soligenix, inc. announced it has completed patient enrollment in its phase 3 "fluorescent light activated synthetic hypericin" (flash) study for sgx301 (synthetic hypericin) in the treatment of cutaneous t-cell lymphoma (ctcl). the study successfully enrolled 169 subjects, following positive interim analysis, which included a prospectively defined, unblinded assessment of the study's primary efficacy endpoint by an independent data monitoring committee (dmc). with enrollment completed, top-line results are expected in the first quarter of 2020. sgx301 is a novel, first-in-class, photodynamic therapy that combines synthetic hypericin, a potent photosensitizer that is applied as an ointment to the cancerous skin lesions and activated using a brief, safe, fluorescent light treatment. this treatment approach is expected to minimize the risk of secondary malignancies (including melanoma) inherent with the frequently employed dna-damaging chemotherapeutic drugs and other photodynamic therapies that are dependent on exposure to ultraviolet a and b light. based on the positive results demonstrated in the phase 2 study of sgx301, the phase 3 trial is a highly powered, double-blind, randomized, placebo-controlled, multicenter trial. the primary efficacy endpoint is assessed as the percent of patients in each of the two treatment groups (i.e., sgx301 and placebo) achieving a successful response of the treated lesions at the end of cycle 1 (week 8) compared to baseline. a successful treatment response is defined as a 50% or greater reduction of the three index lesions treated as determined by the cumulative composite assessment of index lesion severity (cails) scoring system. other secondary measures, including treatment response (including duration), degree of improvement, time to relapse and safety, are further determined by data collected throughout the follow-on open-label portions of the trial in cycle 2 (index lesions treated in all patients) and cycle 3 (all lesions treated in all patients), as well as the six-month follow-up period. a prospectively defined interim analysis was conducted in october 2018 by an independent dmc and was used to verify the underlying assumptions defining the required sample size of the study to maintain its rigorous 90% statistical power. the dmc identified a beneficial sgx301 effect and accordingly adjusted the study sample size to approximately 160. the dmc did not identify any safety concerns.
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