Soligenix: FDA Awards $2.6 Mln Orphan Products Development Grant For Study Of HyBryte To Treat CTCL

Soligenix, Inc. (SNGX), a late-stage biopharmaceutical company focused on rare diseases, announced Tuesday that the U.S. Food and Drug Administration has awarded an Orphan Products Development grant totaling $2.6 million for expanded study of HyBryte in the treatment of Cutaneous T-Cell Lymphoma or CTCL.

The grant for over 4 years would support the evaluation of HyBryte (synthetic hypericin) for expanded treatment in patients with early-stage CTCL.

The company said the grant was awarded to an academic institution that was an enroller in the recently published positive Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study in the treatment of early stage CTCL.

The clinical study RW-HPN-MF-01, "Assessment of Treatment with Visible Light Activated Synthetic Hypericin Ointment in Mycosis Fungoides Patients" is designed as an open-label, multicenter clinical trial. It would enroll around 50 patients at up to six of the highest enrolling clinical centers that participated in the Phase 3 FLASH study.

Christopher J. Schaber, President and CEO of Soligenix, said, "... the FDA is supporting the HyBryte program and giving patients an opportunity to access the therapy in an open-label setting.... The Phase 3 results provide the basis for our upcoming marketing application and this study will serve to embark on potential home-use of the therapy, augment the safety database as well as provide further real-world evidence into the practical use of HyBryte once commercially available."

The Phase 3 CTCL clinical study was partially funded by the National Cancer Institute via a Phase II SBIR grant (#1R44CA210848-01A1) awarded to Soligenix, Inc.

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