Soligenix Advances Novel Visible Light Therapy for Early-Stage Cutaneous T-Cell Lymphoma

Soligenix Inc. (NASDAQ: SNGX) is advancing a novel therapeutic approach for cutaneous T-cell lymphoma through its development of HyBryte, also known as synthetic hypericin. CTCL is recognized by clinicians as one of the most difficult cancers to diagnose accurately in its early stages, creating significant challenges for patients and healthcare providers. Within this challenging diagnostic and treatment landscape, HyBryte represents a potential breakthrough as a visible light-activated photodynamic therapy designed specifically for early-stage CTCL.

Unlike traditional ultraviolet-based phototherapies, which can carry long-term safety risks with cumulative exposure, HyBryte is activated by 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. The company’s Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of this therapy, with regulatory approvals being sought worldwide following successful completion of the second Phase 3 study.

Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Beyond HyBryte, the company’s development programs include expansion of synthetic hypericin into psoriasis, its first-in-class innate defense regulator technology dusquetide for inflammatory diseases including oral mucositis in head and neck cancer, and additional applications in Behçet’s disease. The company maintains a website at https://www.Soligenix.com where additional information about their programs is available.

The company’s Public Health Solutions business segment includes development programs for RiVax®, its ricin toxin vaccine candidate, as well as vaccine programs targeting filoviruses such as Marburg and Ebola, and CiVax, the company’s vaccine candidate for the prevention of COVID-19. These programs incorporate Soligenix’s proprietary heat stabilization platform technology known as ThermoVax®. This business segment has been supported with government grants and contract funding from 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 the treatment of CTCL, particularly for patients with early-stage disease who face limited therapeutic options. The visible light activation mechanism represents a significant departure from conventional approaches, potentially offering improved safety profiles while maintaining therapeutic efficacy. As Soligenix progresses toward potential commercialization, the therapy could provide a much-needed alternative for patients and clinicians navigating the complex CTCL treatment landscape. Additional information about the company’s developments is available through various news sources covering the biotechnology sector.

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