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The phase III Fluorescent Light Activated Synthetic Hypericin (FLASH) study is comparing SGX301, to placebo, in patients with early-stage cutaneous T-cell lymphoma (CTCL). On March 19, 2020, positive topline results from the trial were announced with SGX301 leading to a significantly improved treatment response compared with placebo after six weeks of treatment.1 Subsequently, on April 30, 2020, it was announced that SGX301 continued to significantly improve responses after 12 weeks of therapy compared with placebo.2
SGX301 is a first-in-class photodynamic therapy that is activated by safe visible light. It is formed of 0.25% synthetic hypericin which is a potent photosensitizer that is applied topically to skin lesions and is subsequently activated by fluorescent light 16–24 hours later.
SGX301 has been granted orphan drug designation and fast track designation by the U.S. Food and Drug Administration (FDA) and orphan drug designation by the European Medicines Agency (EMA).
Table 1. Results from the first double-blind treatment cycle1
|
SGX301 n = 116 |
Placebo n = 50 |
p value |
≥ 50% reduction in index lesions using CAILS score at 8 weeks, % |
16 |
4 |
0.04 |
CAILS, Composite Assessment of Index Lesion Severity |
In Cycle 2, all patients received SGX301, meaning data are available for patients receiving six weeks of placebo followed by six weeks of SGX301 (n = 45) and patients who continued SGX301 for a total of 12 weeks (n = 110).2
CTCL is a form of non-Hodgkin lymphoma (NHL) involving the expansion of malignant T-cell lymphocytes that migrate to the skin and cause lesions. The Lymphoma Hub is focusing on T-cell lymphomas as a new Educational Theme.
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