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 compatibility study evaluating HyBryte™ (synthetic hypericin sodium) in the treatment of cutaneous T-cell lymphoma (CTCL) using the commercially ready Daavlin Series 7 visible light device, which recently received 510(k) clearance from U.S. Food and Drug Administration (FDA). The open-label study (protocol HPN-CTCL-02) enrolled 9 patients to receive 8 weeks of HyBryte™ treatment of their cancerous lesions, with an assessment of treatment response conducted at week 10 using the Composite Assessment of Index Lesion Severity (CAILS) score. All subjects were enrolled by Brian Poligone, MD, PhD, at the Rochester Skin Lymphoma Medical Group.
The purpose of the study was to establish that any light device capable of producing visible light of an appropriate and consistent wavelength (500 to 650 nm) was suitable for use with HyBryte™ and extend the pharmacokinetic profile using a recently developed, more sensitive hypericin assay. In addition to meeting these objectives, the efficacy demonstrated strongly substantiates the results of the Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study. The treatment response data of 22% following 8 weeks of twice weekly HyBryte™ therapy recapitulates the results of the FLASH trial, despite the fact that patients in the current study were specifically selected to have more extensive disease consistent with its potential commercial use. Additionally, in this study all patients had improvements in their cumulative CAILS score (average improvement of 36.4%, range 8 to 100%). Results in individual lesions showed that 7 of the 27 index lesions (25.9%) had at least a 50% improvement in their CAILS score and 4 of the 27 index lesions (14.8%) were completely resolved after as little as 8 weeks of treatment. Other key evaluations included measurements of systemic exposure and cardiac output, which yielded extremely low and limited levels of systemic hypericin (plateau concentration of approximately 0.00013 μg/mL) detected in the blood and no observable impact to normal sinus rhythm, reinforcing the safety of HyBryte™.
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