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Hypericin

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Immunologic Factors

Three treatment cycles, each six (6) weeks followed by a two (2) week rest period. Treatment uses 0.25% SGX301 in USP Hydrophilic Ointment (or placebo) applied twice per week followed by fluorescent light therapy.

Cycle 1: Patients randomized 2:1 to active/placebo will have three (3) index lesions treated and evaluated.

Cycle 2: All patients will have three (3) index lesions treated and evaluated with active SGX301 ointment.

Cycle 3: All patients will be given the opportunity to enter an open-label cycle of active SGX301 ointment treatment for all lesions (index and non-index).

Placebo ointment is indistinguishable from ointment containing active SGX301 and is only used in Cycle 1. Treatment paradigm (ointment application and fluorescent light therapy) is identical.

0.25% SGX301 in USP Hydrophilic Ointment applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm\^2 fluorescent light.

SGX301 (synthetic hypericin)

USP Hydrophilic Ointment applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm\^2 fluorescent light.

Placebo

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

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

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

The percentage of patients achieving a treatment response in each of the 2 treatment groups. A treatment response was defined as a ≥50% improvement in CAILS score at Week 8 when compared to the CAILS score at baseline.

The Composite Assessment of Index Lesion Disease Severity (CAILS) score measures: Erythema (or redness) on a scale of 0 (no redness) to 8 (very red), Scaling on a scale of 0 (no scaling) to 8 (all of the lesion is covered by a very rough surface), Plaque Elevation on a scale of 0 (no evidence of plaque above normal skin level) to 3 (plaque shows marked elevation above normal skin level) and Surface Area on a scale of 0 (no lesion/surface area is 0 cm\^2) to 18 (the lesion is larger than 300 cm\^2). A lower score means a better outcome.

The overall CAILS score was calculated by adding the total score as described above for each of the 3 lesions. The overall CAILS score has a range of 0 to 111. A lower score means a better outcome.

The percentage of patients achieving a treatment response at Week 16 that received SGX301 for both Cycle 1 and 2 compared to the response rate in patients that received Placebo in Cycle 1.

The Composite Assessment of Index Lesion Disease Severity (CAILS) score was measured as previously described.

The percentage of patients achieving a treatment response at Week 24 compared at Week 16 in SGX301 treatment group. A treatment response was defined as a ≥50% improvement in CAILS score when compared to the CAILS score at baseline.

The Composite Assessment of Index Lesion Disease Severity (CAILS) score was measured as previously described.

The proportion of patch lesions achieving a treatment response at Week 16 in the SGX301 treatment group compared to Week 8 in the Placebo treatment group. A treatment response was defined as a ≥50% improvement in CAILS score when compared to the CAILS score at baseline for individual lesions.

The Composite Assessment of Index Lesion Disease Severity (CAILS) score was measured as previously described.

The proportion of plaque lesions achieving a treatment response at Week 16 in the SGX301 treatment group compared to Week 8 in the Placebo treatment group. A treatment response was defined as a ≥50% improvement in CAILS score when compared to the CAILS score at baseline for individual lesions.

The Composite Assessment of Index Lesion Disease Severity (CAILS) score was measured as previously described.

Soligenix

Cycle 1 - SGX301

Patients treated with Placebo in Cycle 1. Cycle 1 is the only cycle that used Placebo.

Cycle 1 - Placebo

Patients treated with SGX301 in Cycle 2. Since all patients received SGX301 in Cycle 2, this includes 45 patients that received Placebo in Cycle 1 and 110 patients that continued to receive SGX301 in Cycle 2.

Cycle 2 - SGX301

Patients treated with SGX301 in Cycle 3. Since all patients received SGX301 in Cycle 3, this includes 32 patients that received Placebo in Cycle 1 and 78 patients that continued to receive SGX301 in Cycle 3.

Cycle 3 - SGX301

Any participant that received at least one dose of SGX301 during any cycle of the trial.

Overall SGX301

Three treatment cycles, each six (6) weeks followed by a two (2) week rest period. Treatment uses 0.25% SGX301 in USP Hydrophilic Ointment (or placebo) applied twice per week followed by fluorescent light therapy.

Cycle 1: Patients randomized 2:1 to active/placebo will have three (3) index lesions treated and evaluated.

Cycle 2: All patients will have three (3) index lesions treated and evaluated with active SGX301 ointment.

Cycle 3: All patients will be given the opportunity to enter an open-label cycle of active SGX301 ointment treatment for all lesions (index and non-index).

SGX301 (synthetic hypericin): 0.25% SGX301 in USP Hydrophilic Ointment applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm\^2 fluorescent light.

SGX301

Placebo ointment is indistinguishable from ointment containing active SGX301 and is only used in Cycle 1. Treatment paradigm (ointment application and fluorescent light therapy) is identical.

Placebo: USP Hydrophilic Ointment applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm\^2 fluorescent light.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

White

Black or African American

Asian

Native Hawaiian or Other Pacific Islander

American Indian or Alaska Native

Other

Unknown

Race/Ethnicity, Customized

The baseline analysis population was defined as all participants that were treated with at least one dose of treatment (SGX301 or Placebo)

Richard Straube, MD/Chief Medical Officer

Three treatment cycles, each six (6) weeks followed by a two (2) week rest period. Treatment uses 0.25% SGX301 in USP Hydrophilic Ointment (or placebo) applied twice per week followed by fluorescent light therapy.

Cycle 1: Patients have three (3) index lesions treated with SGX301 (0.25% synthetic hypericin in USP Hydrophilic Ointment) applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm\^2 fluorescent light.

Placebo ointment is indistinguishable from ointment containing active SGX301 and is only used in Cycle 1. Treatment paradigm (ointment application and fluorescent light therapy) is identical.

Cycle 1: Patients have three (3) index lesions treated with Placebo (USP Hydrophilic Ointment) applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm\^2 fluorescent light.

The analysis population was defined as all participants that were treated with at least one dose of treatment (SGX301 or Placebo)

Number of Responders and Non-Responders With a Treatment Response in 3 Treated Lesions as Defined as a ≥50% Improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) Score When Compared to Patients Receiving Placebo

Three treatment cycles, each six (6) weeks followed by a two (2) week rest period. Treatment uses 0.25% SGX301 in USP Hydrophilic Ointment (or placebo) applied twice per week followed by fluorescent light therapy.

Cycle 1: Patients have three (3) index lesions treated with SGX301 (0.25% synthetic hypericin in USP Hydrophilic Ointment) applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm\^2 fluorescent light.

Cycle 2: Patients have three (3) index lesions treated with SGX301 (0.25% synthetic hypericin in USP Hydrophilic Ointment) applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm\^2 fluorescent light.

SGX301 (Cycle 1 & 2 = SGX301)

Placebo ointment is indistinguishable from ointment containing active SGX301 and is only used in Cycle 1. Treatment paradigm (ointment application and fluorescent light therapy) is identical.

Cycle 1: Patients have three (3) index lesions treated with Placebo (USP Hydrophilic Ointment) applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 12 J/cm\^2 fluorescent light.

Placebo (Cycle 1)

The analysis population was defined as all participants that were treated with at least one dose of treatment (SGX301) in Cycle 2

Number of Responders and Non-Responders With a Treatment Response in 3 Treated Lesions as Measured by the Composite Assessment of Index Lesion Disease Severity (CAILS) Score (Cycle 1 and 2 SGX301 vs Cycle 1 Placebo)

Three treatment cycles, each six (6) weeks followed by a two (2) week rest period. Treatment uses 0.25% SGX301 in USP Hydrophilic Ointment (or placebo) applied twice per week followed by fluorescent light therapy.

Cycle 1: Patients have three (3) index lesions treated with SGX301 (0.25% synthetic hypericin in USP Hydrophilic Ointment) applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm\^2 fluorescent light.

Cycle 2: Patients have three (3) index lesions treated with SGX301 (0.25% synthetic hypericin in USP Hydrophilic Ointment) applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm\^2 fluorescent light.

Cycle 3: Patients have three (3) index lesions treated with SGX301 (0.25% synthetic hypericin in USP Hydrophilic Ointment) applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm\^2 fluorescent light.

SGX301 (Cycle 1, 2 & 3 = SGX301)

Number of Responders and Non-Responders With a Treatment Response of 3 Treated Lesions as Measured by the Composite Assessment of Index Lesion Disease Severity (CAILS) Score in Patients Who Received 3 Cycles of SGX301

Patch Lesion Response Rates With Extended Treatment (Cycle 1 & 2 SGX301 vs Cycle 1 Placebo)

The analysis population was defined as all lesions that were treated with at least one dose of treatment (SGX301) in Cycle 2

Plaque Lesion Response Rates With Extended Treatment (Cycle 1 & 2 SGX301 vs Cycle 1 Placebo)

Placebo ointment is indistinguishable from ointment containing active SGX301 and is only used in Cycle 1. Treatment paradigm (ointment application and fluorescent light therapy) is identical.

Placebo: USP Hydrophilic Ointment applied twice per week, covered by opaque bandage for 18-24 hours, then treated with an initial dose of 12 J/cm\^2 fluorescent light.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides)	NCT02448381	Cutaneous T-Cel...	SGX301 (synthet... Placebo	18 Years -	Soligenix
FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides)	NCT02448381	Cutaneous T-Cel...	SGX301 (synthet... Placebo	18 Years -	Soligenix
FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides)	NCT02448381	Cutaneous T-Cel...	SGX301 (synthet... Placebo	18 Years -	Soligenix
FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides)	NCT02448381	Cutaneous T-Cel...	SGX301 (synthet... Placebo	18 Years -	Soligenix

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