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Soligenix Announces Scheduling of Type A Meeting with the U.S. FDA to Review Proposed Study Design for a Second Phase 3 Study Evaluating HyBryte™ in the Treatment of Cutaneous T-Cell Lymphoma
Update on FDA Meeting Outcome Expected Next Month PRINCETON, N.J., May 11, 2023 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a
About this update from Soligenix, Inc.
[{"type":"text","content":"Update on FDA Meeting Outcome Expected Next Month\nPRINCETON, N.J., May 11, 2023 /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 that the United States (U.S.) Food and Drug Administration (FDA) has granted a Type A meeting to discuss the design of a second, Phase 3 pivotal study evaluating HyBryte™ (hypericin sodium) in the treatment of early stage cutaneous T-cell lymphoma (CTCL), a rare cancer, where it has successfully demonstrated statistically significant results in the first Phase 3 clinical trial. The Type A Meeting is the highest priority classification of meeting the FDA grants companies.\n\n \n \n \n \n \n \n\n \n\"Responding to FDA feedback, Soligenix has submitted a confirmatory Phase 3 draft study protocol retaining the key aspects of the first Phase 3 trial,\" stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. \"We look forward to discussing the protocol in detail with FDA. We intend to provide a further update once we have received the minutes from the meeting or when we have more clarity on next steps, which we anticipate having by or before the end of June.\"\nAbout HyBryte™\nHyBryte™ (research name SGX301) is a novel, first-in-class, photodynamic therapy utilizing safe, visible light for activation. The active ingredient in HyBryte™ is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions that is taken up by the malignant T-cells, and then activated by visible light approximately 24 hours later. The use of visible light in the red-yellow spectrum has the advantage of penetrating more deeply into the skin (much more so than ultraviolet light) and therefore potentially treating deeper skin disease and thicker plaques and lesions. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging drugs and other phototherapy that are dependent on ultraviolet exposure. Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In a publis...