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Soligenix Announces Positive Clinical Results from a Comparative Study Evaluating HyBryte™ Against Valchlor® in the Treatment of Cutaneous T-Cell Lymphoma
HyBryte™ demonstrates more rapid and robust treatment response compared to Valchlor® during 12-week treatment course PRINCETON, N.J., June 25, 2024
About this update from Soligenix, Inc.
[{"type":"text","content":"HyBryte™ demonstrates more rapid and robust treatment response compared to Valchlor® during 12-week treatment course\nPRINCETON, N.J., June 25, 2024 /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 positive clinical results from a comparability study evaluating HyBryte™ (synthetic hypericin) versus Valchlor® (mechlorethamine gel) in the treatment of cutaneous T-cell lymphoma (CTCL). The open-label study (protocol HPN-CTCL-04) enrolled 10 patients (5 patients per group) with treatment success defined as a ≥50% improvement in a patient's cumulative mCAILS (modified Composite Assessment of Index Lesion Severity) score after 12 weeks of topical treatment compared to Baseline. The study revealed that HyBryte™ treatment resulted in 60% of patients achieving a 50% or better improvement in their mCAILS score versus 20% of Valchlor® patients, with HyBryte™ having a more favorable safety profile. All subjects were enrolled by Brian Poligone, MD, PhD, at the Rochester Skin Lymphoma Medical Group, Fairport, NY.\n\n \n \n \n \n \n \n\n \n\"Following the positive results from the previous Phase 2 and 3 studies where I previously participated in evaluating HyBryte™, we were excited to support Soligenix's effort to conduct a prospective comparative assessment of HyBryte™ versus Valchlor®,\" stated Dr. Brian Poligone, Director of the Rochester Skin Lymphoma Medical Group and Principal Investigator for the comparability study. \"Despite the small study sample size and a randomization that lead to the HyBryte™ group having patients with more extensive disease, HyBryte™ performed well and the results are consistent with previous studies demonstrating its rapid onset of action and benign safety profile compared to one of the most widely prescribed approved drugs for early-stage CTCL. The positive effect this therapy can have for patients and the outstanding safety profile that HyBryte™ continues to demonstrate is very encouraging. We look forward to continuing to support Soligenix and participating in the upcoming Phase 3 placebo-controlled study.\"\n\"These results support the positive HyBryte™ data from the previously completed Phase 3 FLASH study and demons...