HyBryte™ Phase 3 FLASH Study for the Treatment of Cutaneous T-Cell Lymphoma Published in JAMA Dermatology
- Published findings demonstrate that HyBryte™ treatment statistically significantly reduced CTCL lesion size
- HyBryte™ has potential to address a critical gap in treatment of early-stage CTCL
Excerpt from the Press Release:
PRINCETON, N.J., July 20, 2022 /PRNewswire/ — Soligenix, Inc. (NASDAQ: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the results of its successful Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study evaluating HyBryte™ (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL) has been published in the Journal of the American Medical Association (JAMA) Dermatology.
“The peer reviewed publication of these data in JAMA Dermatology is a testament and further validation to the importance of the findings for the scientific and CTCL disease communities,” stated Ellen Kim, MD, Professor of Dermatology and Medical Director, Dermatology Clinic, Perelman Center for Advanced Medicine at the Hospital of the University of Pennsylvania, and the Lead Principal Investigator for the Phase 3 FLASH study. “With its chronic course and major impact on patient quality of life, CTCL is an orphan disease in urgent need of additional treatment options that are well-tolerated and safe over the long haul. The results from this Phase 3 study, which is the largest double-blind, randomized, placebo-controlled trial in CTCL to date, represents an important leap forward in the development of potential therapies to meet this unmet medical need.”
The published findings demonstrate that HyBryte™ treatment statistically significantly reduced lesion size, with the treatment response further improving over successive 6-week treatment cycles. The primary endpoint evaluated the CAILS (Composite Assessment of Index Lesion Severity) score of three treated index lesions and success was defined as ≥50% reduction in CAILS score relative to baseline.
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