Soligenix, Inc. announced on December 2, 2024, that post-treatment analysis from an open-label study (HPN-CTCL-04) comparing HyBryte™ to Valchlor® in cutaneous T-cell lymphoma (CTCL) patients showed continued improvement. The majority of HyBryte™ treated patients demonstrated further improvement four weeks after stopping treatment, including one achieving a complete response.
Specifically, HyBryte™ treated plaque lesions showed statistically significant improvement compared to Valchlor® treated plaques, with 75% responding lesions for HyBryte™ versus 17% for Valchlor® at Week 16 (p=0.006). Plaque lesions are considered more difficult to treat and are associated with poorer long-term prognosis.
The study also highlighted HyBryte's benign safety profile, with no safety concerns raised during the follow-up period, contrasting with Valchlor® which led to adverse events in 60% of treated patients. These results reinforce HyBryte's potential as a safe and effective treatment option for early-stage CTCL.
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