FDA Grants Fast Track Designation to SGX301 for First-Line Treatment of Cutaneous T-Cell Lymphoma
The U. S. Food and Drug Administration has granted Fast Track designation the synthetic hypericin (SGX301) development program for the first-line treatment of cutaneous T-cell lymphoma.
Fast Track designation from the FDA is reserved for drugs that demonstrate the potential to address an unmet medical need for a serious or life-threatening condition. SGX301 previously received Orphan Drug designation from the FDA.
Cutaneous T-cell lymphoma (CTCL) is a rare type of non-Hodgkin’s lymphoma that begins in the skin. The most common type of CTCL is mycosis fungoides. Cutaneous T-cell lymphoma occurs in about 4% of the approximate 500,000 individuals living with non-Hodgkin lymphoma. Unlike most non-Hodgkin lymphomas, which generally involve B-cell lymphocytes, cutaneous T-cell lymphoma is caused by an expansion of malignant T-cell lymphocytes normally programmed to migrate to the skin. These skin-trafficking malignant T cells migrate to the skin, causing various lesions to appear that may change shape as the disease progresses, typically beginning as a rash and eventually forming plaques and tumors.
SGX301 is a novel photodynamic therapy utilizing safe visible light for activation. The active ingredient in SGX301 is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions and then activated by fluorescent light. Combined with photoactivation, hypericin has demonstrated significant antiproliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from cutaneous T-cell lymphoma patients. In a phase II clinical study, patients experienced a statistically significant (P ? .04) improvement with topical hypericin treatment vs placebo (58.3% vs 8.3%, respectively).
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