Soligenix, Inc. announced 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.

In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p=0.04) improvement with topical hypericin treatment whereas the placebo was ineffective. HyBryte?? has received orphan drug and fast track designations from the U.S. Food and Drug Administration (FDA), as well as orphan designation from the European Medicines Agency (EMA).

It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL that it affects approximately 31,000 individuals in the U.S. (based on SEER data, with approximately 3,200 new cases seen annually) and approximately 38,000 individuals in Europe (based on ECIS prevalence estimates, with approximately 3,800 new cases annually).