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FAQ: Soligenix's Phase 3 Trial Milestone for HyBryte™ in Cutaneous T-Cell Lymphoma
TL;DR
Soligenix's Phase 3 trial milestone positions it to potentially deliver the first FDA-approved photodynamic therapy for CTCL, offering a competitive edge in the rare disease market.
The FLASH2 study is a randomized, double-blind, placebo-controlled Phase 3 trial building on previous significant results, with 50 patients enrolled for interim analysis toward FDA approval.
This advancement brings hope to patients with a rare skin cancer by moving closer to an FDA-approved treatment that could improve their quality of life.
Soligenix's HyBryte therapy uses synthetic hypericin in a novel photodynamic approach, with promising early results also being studied at the University of Pennsylvania.
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Soligenix has completed the planned enrollment of 50 patients necessary for the interim analysis in its 80-patient confirmatory Phase 3 clinical trial evaluating HyBryte™ (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma.
This milestone represents a crucial step forward for the FLASH2 study and brings the investigational treatment significantly closer to potential FDA approval, potentially making it the first FDA-approved photodynamic therapy specifically indicated for CTCL.
HyBryte™ (synthetic hypericin) is an investigational photodynamic therapy being evaluated for the treatment of cutaneous T-cell lymphoma, a rare form of skin cancer.
The FLASH2 study is a randomized, double-blind, placebo-controlled confirmatory Phase 3 clinical trial that builds upon the previous statistically significant Phase 3 FLASH study.
The promising early results are further corroborated by an ongoing investigator-initiated study being conducted at the University of Pennsylvania.
The complete Phase 3 trial involves 80 patients, with 50 patients now enrolled for the interim analysis.
The latest news and updates relating to SNGX are available in the company's newsroom at https://ibn.fm/SNGX.
This information was released by BioMedWire, a specialized communications platform focused on developments in Biotechnology, Biomedical Sciences and Life Sciences sectors, which is part of the Dynamic Brand Portfolio at IBN.
Curated from InvestorBrandNetwork (IBN)
