Assessment of treatment with visible light activated synthetic hypericin ointment in mycosis fungoides patients. - 7. Project summary/abstract mycosis fungoides/cutaneous t cell lymphoma (MF/ctcl)…

Assessment of treatment with visible light activated synthetic hypericin ointment in mycosis fungoides patients. - 7. Project summary/abstract mycosis fungoides/cutaneous t cell lymphoma (MF/ctcl) is a rare, indolent non-hodgkin's lymphoma (NHL), without a known cure, that presents as skin patches, plaques, tumors, or erythroderma with significant morbidity and impact on health-related quality of life (HR-QOL). Effective early treatment improves HR-QOL and may prevent disease progression. As per current nccn guidelines, many skin-directed therapies (sdts) are used for the treatment of early stage MF/ctcl including topicals, ultraviolet (UV) phototherapy, and radiation therapy. None have been FDA-approved for first-line therapy and most are used off-label. Given the chronic, recurrent nature of MF/ctcl, most patients require repeat courses of therapy and trying other therapies. The use of several sdts are limited by skin irritation/dermatitis and long-term cumulative toxicity. Given this, there is an urgent need for additional sdts for ctcl with fewer side effects. Topical hypericin is non-mutagenic, not systemically absorbed, activated by noncarcinogenic visible light, selectively taken up by tumor cells in the skin (up to 10-fold) and induces mitochondrial apoptosis. Phase 1, 2 and 3 clinical studies in MF/ctcl have demonstrated safety and efficacy. A recent multicenter, randomized, placebo-controlled, blinded phase 3 study, enrolled 169 patients with stage IA, IB or IIA ctcl and administered treatments twice weekly for at least 6 weeks (cycle 1). In cycle 1, 116 subjects received SGX301 to 3 index lesions with an overall response rate (ORR) of 16% compared to placebo ORR 4% (n=50, p=0.04). In cycle 2 the ORR in patients receiving SGX301 for both cycles (12 weeks) was 40% (p