ClinicalTrials.gov ID: NCT02448381
Sponsor: Soligenix

Brief Summary:

To evaluate the use of SGX301, a topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).

Positive results were announced earlier this year for the FLASH Study, a phase 3 clinical trial in CTCL, by Soligenix. SGX301 is a novel first-in-class 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, is taken up by the malignant T-cells, and then activated by fluorescent light 16 to 24 hours later. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging chemotherapeutic drugs and other photodynamic therapies that are dependent on ultraviolet exposure. In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p=0.04) improvement with topical hypericin treatment in comparison to the placebo. SGX301 has received orphan drug and fast track designations from the US Food and Drug Administration (FDA), as well as orphan designation from the European Medicines Agency (EMA).

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FLUORESCENT LIGHT ACTIVATED SYNTHETIC HYPERICIN (FLASH) 
Previously published in the Cutaneous Lymphoma Foundation's Forum 2018 Issue 1 newsletter.

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Determine the Efficacy of Topical SGX301 (Synthetic Hypericin) and Fluorescent Bulb-Light Irradiation for the Treatment of Cutaneous T-Cell Lymphoma (CTCL) is currently being conducted by Soligenix, Inc. located in Princeton, NJ. Approximately 30 centers across the United States are participating in this trial with several new centers potentially joining the study in the first quarter of 2018. This trial aims to evaluate treatment response to Synthetic Hypericin (the active ingredient in the study drug SGX301) and address the growing demand for topical, skin directed therapies to treat early stage CTCL. The uniqueness of this experimental therapy stems from the photodynamic treatment which incorporates the application of the study ointment in combination with safe, visible fluorescent light as opposed to the more conventional (and potentially harmful) ultraviolet light.

Although the trial is blinded to all patients, clinical study sites and to Soligenix (i.e., no one knows if they getting or giving SGX301 or placebo during the double-blind portion of the study), the response to the study thus far has been very positive from both the patients’ experiences as well as the hospitals and clinics enrolling patients. To date, the study drug has been well tolerated by the patients participating with no serious adverse events related to study drug being reported thus far. Although the trial begins with a double-blind portion, all participants in the trial eventually receive open label SGX301 therapy and if the patients like the response that they see when using the active study drug, a third, optional open label portion of the trial is available to them that allows patients to continue to treat their disease areas with another regimen of SGX301 therapy. Soligenix remains encouraged by the response to this trial and is pleased to report that the majority of patients who have participated in the double-blind portion have elected to continue into the optional open-label portion of this study, which we view as a testimonial to the perceived benefit the patients believe this potential new therapy brings them.