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HyBryte™ Expanded Treatment Continues to Demonstrate Positive Outcomes in Early-Stage Cutaneous T-Cell Lymphoma
Study Supported by $2.6 Million FDA Orphan Products Development Grant PRINCETON, N.J., Jan. 14, 2025 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix
About this update from Soligenix, Inc.
[{"type":"text","content":"Study Supported by $2.6 Million FDA Orphan Products Development Grant\nPRINCETON, N.J., Jan. 14, 2025 /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 an interim update on the open-label, investigator-initiated study (IIS) evaluating extended HyBryte™ (synthetic hypericin) treatment for up to 12 months in patients with early-stage cutaneous T-cell lymphoma (CTCL). The trial is sponsored by Ellen Kim, MD, Director, Penn Cutaneous Lymphoma Program, Vice Chair of Clinical Operations, Dermatology Department, and Professor of Dermatology at the Hospital of the University of Pennsylvania who was a leading enroller in the Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study for the treatment of early-stage CTCL. To date, nine patients have been enrolled and treated with HyBryte™ over a time period of up to 54 weeks. Patients have responded positively to HyBryte™ therapy, with over 70% (5 of the 6 subjects who have completed at least 18 weeks of therapy) already achieving \"Treatment Success\". Treatment Success is predefined in the study's protocol as a greater than or equal to 50% improvement in the cumulative mCAILS (modified Composite Assessment of Index Lesion Severity) score compared to Baseline. Of the five Treatment Successes, three were achieved within the first 12 weeks of treatment, with two patients achieving a \"complete response\" by 18 weeks. Of the remaining patients, two have recently started the study and two had to drop from the study for logistical reasons (e.g., need to care for an elderly parent), with one showing a substantial improvement (>30%) by their Week 18 visit. In addition, HyBryte™ appears to be safe and well tolerated in all patients.\n\n \n \n \n \n \n \n\n \n\"The complete response rate, consistent treatment response and safety profile across multiple clinical studies to date with HyBryte™ has been exciting to see,\" noted Dr. Kim, Principal Investigator of the IIS and Lead Investigator of the FLASH2 study. \"In the first Phase 3 FLASH study, HyBryte™ was shown to be efficacious with a benign safety profile compared to the current therapies of steroids, chemotherapeutics and ultraviolet light in this c...