NetworkNewsAudio Announces Audio Press Release (APR) on Promising First-Line Therapy for Rare Skin Cancer
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Soligenix Inc. is advancing HyBryte, its late-stage therapy for cutaneous T-cell lymphoma (CTCL), a rare and chronic cancer that primarily affects older adults. HyBryte has shown strong promise as a first-line treatment option for early-stage CTCL, a market estimated at nearly $1 billion globally, with 70% of that opportunity in the U.S. The therapy has already received orphan drug designations in both the U.S. and Europe, as well as FDA Fast Track status. Unlike traditional treatments that can take a year or more to show efficacy, HyBryte demonstrated statistically significant results in just six weeks in its initial phase 3 trial. A second confirmatory phase 3 study, FLASH2, is now underway in the U.S. and Europe and is designed to provide further validation of HyBryte's safety and effectiveness, with top-line results expected in 2026.
HyBryte's safety profile stands out in a treatment space where many existing options carry significant side effects, including DNA damage and long-term carcinogenic risks. The therapy's use of synthetic hypericin activated by non-carcinogenic visible light — rather than ultraviolet light — offers a safer alternative, especially for older patients. With minimal systemic absorption and strong responses across both patch and plaque lesions, HyBryte has the potential to redefine the standard of care for CTCL. Soligenix's advancements in this rare disease area highlight the growing urgency and opportunity in addressing complex conditions that disproportionately affect aging populations.
About Soligenix Inc.
Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Its Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte(TM) ('SGX301' or synthetic hypericin) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma ('CTCL'). With successful completion of the second Phase 3 study, regulatory approvals will be sought to support potential commercialization worldwide. Development programs in this business segment also include expansion of synthetic hypericin ('SGX302') into psoriasis, the company's first-in-class innate defense regulator ('IDR') technology, dusquetide ('SGX942') for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and ('SGX945') in Behçet's disease.
The company's Public Health Solutions business segment includes development programs for RiVax(R), its ricin toxin vaccine candidate, as well as its vaccine programs targeting filoviruses (such as Marburg and Ebola) and CiVax(TM), the company's vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of Soligenix's vaccine programs incorporates the use of its proprietary heat stabilization platform technology, known as ThermoVax(R). To date, this business segment has been supported with government grants and contract funding from the National Institute of Allergy and Infectious Diseases ('NIAID'), the Defense Threat Reduction Agency ('DTRA') and the Biomedical Advanced Research and Development Authority ('BARDA').
For further information, visit the company's website at Soligenix Inc.
About NetworkNewsAudio
NetworkNewsAudio, a service of NetworkNewsWire (NNW), a multifaceted financial news and publishing company powered by IBN ('InvestorBrandNetwork'), allows you to sit back and listen to market updates, interviews and company press releases. NetworkNewsAudio keeps you informed on publicly traded companies we're watching. The audio clips provide snapshots of position, opportunity and momentum. NetworkNewsAudio is a Brand Awareness Distribution Solution from NetworkNewsWire.
For more information, visit: www.NetworkNewsAudio.com
NetworkNewsWire (NNW) is a comprehensive provider of news aggregation and syndication, enhanced press release services and a full array of social communication solutions. As a multifaceted financial news and distribution company with an extensive team of journalists and writers, NNW has the unparalleled ability to reach a wide audience of investors, consumers, journalists and the general public. With an ever-growing distribution network of more than 5,000 key syndication outlets across the nation, NNW cuts through the overload of information in today's markets bringing its clients unparalleled visibility, recognition and brand awareness. NetworkNewsWire is where news, content and information converge.
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: https://NNW.fm/Disclaimer
Forward-Looking Statements
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. In evaluating such statements, prospective investors should review carefully various risks and uncertainties identified in this release and matters set in the company's SEC filings. These risks and uncertainties could cause the company's actual results to differ materially from those indicated in the forward-looking statements.
Corporate Communications
IBNAustin, Texas
www.InvestorBrandNetwork.com 512.354.7000 Office
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