Cutaneous T-Cell Lymphoma (CTCL), a type of non-Hodgkin’s lymphoma affecting about 6% of patients, primarily manifests as Mycosis Fungoides in its early stages. This chronic disease, characterized by the migration of malignant T-cells to the skin's surface, leads to uncomfortable lesions, tumors, and plaques. Currently, there is no FDA-approved first-line therapy for CTCL, with treatments either used off-label or reserved for when other therapies fail, often accompanied by serious side effects.
HyBryte™ emerges as a potential front-line treatment, utilizing synthetic hypericin in an ointment activated by visible fluorescent light. This photodynamic therapy targets T-cells in the skin, minimizing systemic toxicity and reducing the risk of disease progression without the mutagenic or carcinogenic risks associated with other light sources. The mechanism involves the accumulation of hypericin in T-cells, which, when activated by light, produces oxygen radicals leading to cellular toxicity and targeted cell death.
Clinical studies, including Phase 1, 2, and 3 trials, have demonstrated HyBryte™'s safety and efficacy in treating CTCL lesions. Soligenix, in collaboration with Dr. Ellen Kim from the University of Pennsylvania, is conducting further research with partial funding from the US Food & Drug Administration. This ongoing study aims to evaluate HyBryte™'s effectiveness over a year-long treatment period, with plans for a confirmatory Phase 3 study to support potential marketing approval.
Beyond CTCL, synthetic hypericin shows potential in treating psoriasis, another condition characterized by T-cell migration to the skin. However, unlike CTCL, the T-cells in psoriasis are not malignant. With over 7 million adults in the US affected by psoriasis, the exploration of hypericin and visible light phototherapy offers a promising avenue for treatment, minimizing the risks associated with ultraviolet light exposure.
