Soligenix, Inc. announced on April 14, 2025, interim results from its ongoing open-label, investigator-initiated study (IIS) evaluating extended HyBryte™ treatment for early-stage cutaneous T-cell lymphoma (CTCL). The data showed that 75% of evaluable patients (6 of 8) achieved 'Treatment Success' after 18 weeks of treatment.
Treatment Success is defined as a greater than or equal to 50% improvement in the cumulative mCAILS score compared to Baseline. This rapid response is a distinct advantage of HyBryte™ therapy, as many other CTCL treatments can take six to twelve months to achieve a clinically meaningful response.
The study also reported three patients achieving a complete response, and HyBryte™ continued to be safe and well tolerated. These results reinforce HyBryte's potential as a safe and fast-acting therapy for this chronic and underserved cancer, providing further confidence for the ongoing confirmatory Phase 3 FLASH2 study.
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