Soligenix, Inc. (SNGX), a late-stage biopharmaceutical company, Monday announced positive interim results from the ongoing investigator-initiated study (IIS) evaluating extended HyBryte in patients with early-stage cutaneous T-cell lymphoma (CTCL).
Nine patients have been enrolled and treated with HyBryte over a period of up to 54 weeks in the IIS. In the study, 75 percent of patients had a treatment success, which is a 50 percent or more improvement in the cumulative mCAILS (modified Composite Assessment of Index Lesion Severity) score. Further, HyBryte appeared to be safe and well tolerated in all patients.
"Following the initial Phase 3 FLASH study, which demonstrated the safety and efficacy of shorter courses of HyBryte therapy, we are pleased to see that continuing treatment for longer time periods is resulting in the anticipated improved outcomes for patients. The majority of patients show a strong treatment response by Week 18, a noticeable advantage over other therapies that may take six to 12 months to show improvement," stated Christopher J. Schaber, President and Chief Executive Officer of Soligenix.
A confirmatory Phase 3 FLASH2 replication study of HyBryte is underway.
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