Soligenix, Inc. announced that the United States (U.S.) Food and Drug Administration (FDA) has granted a Type A meeting to discuss the design of a second, Phase 3 pivotal study evaluating HyBryte(TM) (hypericin sodium) in the treatment of early stage cutaneous T-cell lymphoma (CTCL), a rare cancer, where it has successfully demonstrated statistically significant results in the first Phase 3 clinical trial. The Type A Meeting is the highest priority classification of meeting the FDA grants companies. HyBryte(TM).

HyBryte(TM), has received orphan drug and fast track designations from the FDA, as well as orphan designation from the European Medicines Agency (EMA). In addition, the FDA awarded an Orphan Products Development grant to support the evaluation of HyBryte(TM") for expanded treatment in patients with early-stage CTCL, including in the home use setting. 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 over 25,000 individuals in the U.S., with approximately 3,000 new cases seen annually.