Soligenix Inc. (NASDAQ: SNGX) announced that results from a study comparing its HyBryte treatment to Valchlor for cutaneous T-cell lymphoma have been published in Oncology and Therapy journal.

The 12-week study evaluated HyBryte (synthetic hypericin) against Valchlor (mechlorethamine) in patients with cutaneous T-cell lymphoma. According to the published results, 60% of HyBryte patients achieved treatment success, defined as at least 50% improvement in their cumulative mCAILS score, compared to 20% of Valchlor patients. The study did not achieve statistical significance due to small sample size.

HyBryte patients showed an average cumulative improvement of 52.5% in mCAILS scores at 12 weeks versus 34.7% for Valchlor patients. All HyBryte patients tolerated the treatment well with no related adverse events, while 60% of Valchlor patients experienced at least one treatment-related adverse event, including rashes and dermatitis. One Valchlor patient required permanent discontinuation due to allergic contact dermatitis.

"Despite the small study sample size and a randomization that lead to the HyBryte group having patients with more extensive disease, HyBryte performed well," stated Dr. Brian Poligone, Principal Investigator for the study and Director of the Rochester Skin Lymphoma Medical Group.

HyBryte is a photodynamic therapy that uses synthetic hypericin activated by visible light. The treatment has received orphan drug and fast track designations from the FDA and orphan designation from the European Medicines Agency. Soligenix is currently conducting a second Phase 3 trial called FLASH2 following regulatory requirements for a confirmatory study to support marketing approval.