Soligenix (NASDAQ: SNGX), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today completion of patient enrollment in its Phase 3 “Fluorescent Light Activated Synthetic Hypericin” (“FLASH”) study for SGX301 (“synthetic hypericin”) in the treatment of cutaneous T-cell lymphoma (“CTCL”). According to the update, 169 subjects were successfully enrolled in the study following positive interim analysis, which included a prospectively defined, unblinded assessment of the study’s primary efficacy endpoint by an independent Data Monitoring Committee (“DMC”). “We are pleased to have completed enrollment and look forward to the top-line results in the first quarter of next year, particularly in light of the DMC recommendation at the interim analysis which observed a beneficial drug effect,” Soligenix President and Chief Executive Officer Christopher J. Schaber, PhD, said in the news release. “We have invested a significant amount of the Company’s resources into the CTCL development program and continue to positively position this fast-tracked program for approval. We believe SGX301 has the potential to be a valuable therapy in the front-line treatment of early stage CTCL, which is an orphan disease and area of unmet medical need.”
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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. Soligenix’s Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, its first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (“BDP”) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn’s disease (SGX203) and acute radiation enteritis (SGX201). Soligenix’s Public Health Solutions business segment includes active development programs for RiVax(R), its ricin toxin vaccine candidate, OrbeShield(R), its GI acute radiation syndrome therapeutic candidate and SGX943, its therapeutic candidate for antibiotic resistant and emerging infectious disease. The development of the company’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 grant and contract funding from the National Institute of Allergy and Infectious Diseases (“NIAID”), the Defense Threat Reduction Agents (“DTRA”) and the Biomedical Advanced Research and Development Authority (“BARDA”). For more information, visit the company’s website at www.Soligenix.com.
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