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Soligenix Announces Scheduling of Type A Meeting with the U.S. FDA for HyBryte™ New Drug Application in the Treatment of Cutaneous T-Cell Lymphoma
Update on FDA Meeting Outcome Expected by End of April PRINCETON, N.J., April 3, 2023 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the
About this update from Soligenix, Inc.
[{"type":"text","content":"Update on FDA Meeting Outcome Expected by End of April\nPRINCETON, N.J., April 3, 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 contents of a refusal to file (RTF) letter previously issued regarding the Company's new drug application (NDA) for HyBryte™ (synthetic hypericin) in the treatment of early stage cutaneous T-cell lymphoma (CTCL), a rare cancer, where it has successfully demonstrated statistically significant results in a Phase 3 clinical trial.\n\"We look forward to the Type A meeting which will provide an opportunity to discuss the issues raised in the RTF letter with respect to the NDA for HyBryte™ in CTCL,\" stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. \"We remain determined to work with the FDA staff as quickly as possible to better understand the open issues and clarify the potential path forward. 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 April.\"\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-c...