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Soligenix Completes Enrollment in its Pivotal Phase 3 Clinical Trial of SGX301 in the Treatment of Cutaneous T-cell Lymphoma
PRINCETON, N.J., Dec. 3, 2019 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on
About this update from Soligenix, Inc.
[{"type":"text","content":" PRINCETON, N.J., Dec. 3, 2019 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today it has completed 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). The study successfully enrolled 169 subjects, 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). With enrollment completed, top-line results are expected in the first quarter of 2020. \nSGX301 is a novel, first-in-class, photodynamic therapy that combines synthetic hypericin, a potent photosensitizer that is applied as an ointment to the cancerous skin lesions and activated using a brief, safe, fluorescent light treatment. This treatment approach is expected to minimize the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging chemotherapeutic drugs and other photodynamic therapies that are dependent on exposure to ultraviolet A and B light. \n\"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,\" stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. \"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.\"\n\"SGX301 has the potential to have a significant impact on the lives of CTCL patients while minimizing their exposure to potential secondary cancers,\" stated Richard Straube, MD, Senior Vice President and Chief Medical Officer of Soligenix. \"We would like to thank the DMC members, our esteemed medical advisory board and our dedicated clinical investigators for their ongoing ...