Visible Light Activated Synthetic Hypericin Ointment for the Treatment of Patients with Mycosis Fungoides

PRIMARY OBJECTIVE:

I. To assess the benefit of continuous treatment with synthetic hypericin ointment and visible light activation in patients with mycosis fungoides (MF) stage IA, IB, IIA, as assessed every 6 weeks by changes in the cumulative Composite Assessment of Index Lesion Severity (CAILS) score of up to 5 representative index lesions.

SECONDARY OBJECTIVES:

I. Remission of disease defined as a “Complete Response” (CAILS=0).

II. The general assessment of overall health of the patients (Physician's Global Assessment [PGA]).

III. The extent of total disease (Modified Severity Weighted Assessment Tool [mSWAT]).

IV. The extent of itching, often a major component of the disease (Visual Analog Scale for itch [VASitch]).

V. The change in CAILS score for each index lesion.

VI. The relative change in CAILS score for lesions classified as patch compared to plaque.

VII. Change in quality of life (QOL) (Skindex-29 and Patient Benefit Index [PBI]) over the treatment period.

VIII. Differential effects of treatment based on baseline disease characteristics (stage of disease at enrollment, subtype of disease [classic, hypopigmented, folliculotropic], predominate lesion type [patch/plaque]), and the effect on patch versus plaque lesions.

IX. The safety of SGX301 therapy for up to 54 weeks of therapy.

EXPLORATORY OBJECTIVES:

I. Expression and impact of treatment on tumor cell apoptosis and other biomarkers using immunohistochemistry (IHC) and genomic/epiproteomic profiling.

II. Evaluate impact of treatment on minimal residual disease (MRD) in skin and blood as measured by high-throughput T-cell receptor sequencing (HTS).

OUTLINE:

Patients apply synthetic hypericin ointment topically to all lesions selected twice a week. Patients then cover the area with opaque bandages or clothing. After 24 hours, lesion are then exposed to visible light treatment. Treatment continues for up to 54 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo skin punch biopsy and blood sample collection throughout the study.