Cutaneous T-cell lymphoma presents significant diagnostic challenges in its early stages, creating a difficult treatment landscape for clinicians and patients. Soligenix Inc. is developing HyBryte, a visible light-activated photodynamic therapy that represents a novel approach to addressing this rare disease. The therapy, also known as synthetic hypericin, is designed specifically for early-stage CTCL treatment.
Unlike traditional ultraviolet-based phototherapies that carry long-term safety risks with cumulative exposure, HyBryte utilizes visible light in the red-yellow spectrum. This mechanism allows for targeted treatment of malignant T-cells in the skin while minimizing damage to surrounding healthy tissue. Clinical data reported by Soligenix indicate that HyBryte has demonstrated statistically significant efficacy in reducing CTCL lesions in patients with early-stage disease.
Soligenix is a late-stage biopharmaceutical company focused on developing products for rare diseases with unmet medical needs. The company’s Specialized BioTherapeutics business segment is advancing HyBryte toward potential commercialization following successful completion of a second Phase 3 study. Regulatory approvals will be sought to support potential worldwide commercialization of the therapy.
The company’s development programs also include expanding synthetic hypericin into psoriasis treatment and advancing first-in-class innate defense regulator technology for inflammatory diseases. Additional research focuses on dusquetide for oral mucositis in head and neck cancer patients and related compounds for Behçet’s disease. Further information about the company’s research and development efforts is available at https://www.Soligenix.com.
Soligenix maintains a Public Health Solutions business segment that includes vaccine development programs targeting ricin toxin, filoviruses such as Marburg and Ebola, and COVID-19 prevention through its CiVax candidate. These programs incorporate the company’s proprietary heat stabilization platform technology called ThermoVax. This business segment has received support through government grants and contract funding from agencies including the National Institute of Allergy and Infectious Diseases, the Defense Threat Reduction Agency, and the Biomedical Advanced Research and Development Authority.
The development of HyBryte addresses critical gaps in CTCL treatment by providing a targeted approach that minimizes long-term safety concerns associated with existing therapies. As Soligenix moves toward potential commercialization, the therapy represents an important advancement for patients with this challenging form of lymphoma. The company’s broader research portfolio demonstrates a commitment to addressing multiple areas of unmet medical need through innovative therapeutic approaches.
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