Cutaneous T-Cell Lymphoma Tx Designated Fast Track
Soligenix announced that the Food and Drug Administration (FDA) has granted a Fast Track designation for SGX301 (synthetic hypericin) for the first-line treatment of cutaneous T-cell lymphoma (CTCL).
CTCL is a class of non-Hodgkin's lymphoma (NHL), a type of cancer that affects the white blood cells. In a Phase 2 clinical study of CTCL patients, there was a statistically significant (P<0.04) improvement with topical hypericin treatment (58.3%) vs. placebo (8.3%).
SGX301 is a first-in-class photodynamic therapy that uses safe visible light for activation. Synthetic hypericin is a strong photosensitizer that is applied topically to skin lesions and then activated by fluorescent light. Hypericin combined with photoactivation has shown significant antiproliferative effects on activated normal human lymphoid cells and growth inhibition of malignant T-cells in CTCL patients.
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