Trial Profile
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
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 22 Aug 2023
Price :
$35
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At a glance
- Drugs Hypericin sodium (Primary)
- Indications Cutaneous T-cell lymphoma; Mycosis fungoides
- Focus Registrational; Therapeutic Use
- Acronyms FLASH
- Sponsors Soligenix
- 21 Aug 2023 According to Soligenix media release, company announced positive clinical results from a compatibility study evaluating HyBryt in the treatment of CTCL that confirmed and extended response results from the first Phase 3 study conducted
- 11 May 2023 According to Soligenix media release, announced that the United States (U.S.) Food and Drug Administration (FDA) has granted a Type A meeting to review proposed study design for a second, Phase 3 pivotal study evaluating HyBryte™ (hypericin sodium) in the treatment of early stage cutaneous T-cell lymphoma (CTCL).
- 04 May 2023 Results published in the Soligenix media release.