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Soligenix Receives Pediatric Investigational Plan Waiver for HyBryte™ in CTCL from the European Medicines Agency
PRINCETON, N.J., June 10, 2021 /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., June 10, 2021 /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 it has received a Pediatric Investigation Plan (PIP) waiver from the European Medicines Agency (EMA) for HyBryte™ (SGX301 or hypericin), which has recently and successfully concluded a Phase 3, pivotal clinical study for the treatment of early stage cutaneous T-cell lymphoma (CTCL).\n\n \n \n \n \n \n \n\n \nAs part of the regulatory process for the registration of new medicines with the EMA, pharmaceutical companies are required to provide a PIP outlining the Company's strategy for investigation of the new medicinal products in the pediatric population. In some instances, a waiver negating the need for a PIP for certain conditions may be granted by the EMA when development of a medicine for use in children is not feasible or appropriate, as is the case for HyBryte™ in CTCL which is extremely rare in children. \n\"This achievement is an important regulatory milestone as we move forward with marketing applications worldwide,\" stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. \"The PIP waiver allows us to work towards advancing a marketing authorization application (MAA) with EMA in a more cost-effective manner since we will not need to expend significant time and resource to conduct a pediatric clinical study in the European Union. With the support of key patient advocacy organizations, such as the Cutaneous Lymphoma Foundation, and key opinion leaders, we are moving towards marketing approval and commercialization of HyBryte™, with the initial focus on the U.S. market followed by a MAA submission in Europe shortly thereafter.\"\nAbout HyBryte™\nHyBryte™ (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 16 to 24 hours later which triggers apoptosis of the cell. The use of visible light in the red-yellow spectrum has the advantage of penetrating more deeply into the ...