In this episode of The Onco’Zine Brief Peter Hofland Ph.D. talks with Ellen J. Kim, MD. Kim is the Medical Director of the Dermatology Clinic at the Perelman Center for Advanced Medicine and Professor of Dermatology at the Hospital of the University of Pennsylvania. She is also the Lead Principal Investigator for the Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study in cutaneous T-cell lymphoma (CTCL). This study is the largest multicenter, randomized, double-blind, placebo-controlled, skin-directed therapy study in cutaneous T-cell lymphoma, to date, enrolling a total of 169 patients.

In our program today Hofland and Kim talk about the success of HyBryte™ (previously known as (SGX301); hypericin ointment 0.25%) in the broad cutaneous T-cell lymphoma patient population.

HyBryte™, being developed by Soligenix, a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, is a novel, first-in-class, photodynamic therapy utilizing safe, visible light for activation.

The active ingredient in HyBryte™ is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions that is taken up by the malignant T-cells, and then activated by visible light 16 to 24 hours later. The use of visible light in the red-yellow spectrum has the advantage of penetrating more deeply into the skin (much more so than ultraviolet light) and therefore potentially treating deeper skin disease and thicker plaques and lesions. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging drugs and other types of phototherapy that are dependent on ultraviolet exposure.

Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited the growth of malignant T-cells isolated from CTCL patients. In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p=0.04) improvement with topical hypericin treatment whereas the placebo was ineffective.

HyBryte™ has received orphan drug and fast track designations from the FDA, as well as an orphan designation from the European Medicines Agency (EMA).

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Reference
FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides) - NCT02448381