Soligenix, Inc. announced that new data from supportive trials of HyBryte™ (synthetic hypericin) in treating cutaneous T-cell lymphoma (CTCL) will be presented at the European Organisation for Research and Treatment of Cancer (EORTC) Cutaneous Lymphoma Tumour Group Annual Meeting in Lausanne, Switzerland, October 9-11, 2024. The presentations highlight improved response rates with extended treatment and increased light doses, offering a potential advancement in CTCL management.
Presentations at EORTC Meeting
Dr. Ellen Kim from the University of Pennsylvania will present a poster on expanded preliminary results from an investigator-initiated study (RW-HPN-MF-01). Dr. Brian Poligone, Director of the Rochester Skin Lymphoma Medical Group, will give an oral presentation on recent results from two expanded treatment studies (HPN-CTCL-02 and HPN-CTCL-04).
The oral presentation by Dr. Poligone is titled "Phase 2a Study of Topical 0.25% Hypericin in Mycosis Fungoides: Results and Review of the FLASH Study" and will take place on October 9, 2024. Dr. Kim's poster presentation is titled "Topical hypericin ointment photodynamic therapy for early stage mycosis fungoides/CTCL – a Phase 2 real world investigator-initiated study."
Key Findings from Supportive Studies
These presentations will elaborate on findings from supportive studies, demonstrating the utility of longer treatment times (Study RW-HPN-MF-01), the lack of significant systemic exposure to hypericin after topical application (Study HPN-CTCL-02), and its relative efficacy and tolerability compared to Valchlor® (Study HPN-CTCL-04).
About HyBryte™ and the FLASH Trial
HyBryte™ (SGX301) is a first-in-class photodynamic therapy that uses safe, visible light for activation. The active ingredient, synthetic hypericin, is applied topically to skin lesions and taken up by malignant T-cells, then activated by visible light approximately 24 hours later. This approach avoids the risk of secondary malignancies associated with DNA-damaging drugs and ultraviolet light exposure.
The published Phase 3 FLASH trial enrolled 169 patients with Stage IA, IB, or IIA CTCL. In the first double-blind treatment cycle, 16% of patients receiving HyBryte™ achieved at least a 50% reduction in their lesions compared to 4% in the placebo group (p=0.04). In the second open-label cycle, the response rate among the 12-week treatment group was 40% (p<0.0001 vs placebo). A third optional cycle showed that 49% of patients receiving HyBryte™ throughout all three cycles demonstrated a positive treatment response (p<0.0001 vs placebo).
Ongoing Development and FLASH2 Trial
Following the first Phase 3 study, the FDA and EMA indicated the need for a second successful Phase 3 trial for marketing approval. The FLASH2 study, expected to begin before the end of 2024, will enroll approximately 80 subjects with early-stage CTCL. This study extends the double-blind, placebo-controlled assessment to 18 weeks of continuous treatment, with the primary endpoint assessment at the end of this period. The FDA has expressed a preference for a longer duration comparative study, and discussions are ongoing.
Cutaneous T-Cell Lymphoma (CTCL) Overview
CTCL is a rare class of non-Hodgkin's lymphoma affecting approximately 31,000 individuals in the U.S. and 38,000 in Europe. It involves malignant T-cell lymphocytes that migrate to the skin, forming lesions. While treatments can regress lesions, they often return. There is currently no cure for CTCL.
