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HyBryte™ Expanded Treatment Trial in Cutaneous T-Cell Lymphoma Opens Enrollment

Study Supported by $2.6 Million FDA Orphan Products Development Grant

Excerpt from the Press Release:

PRINCETON, N.J., Aug. 10, 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 patient enrollment has been opened for the investigator-initiated study (IIS) at the University of Pennsylvania, supported by a $2.6 million Orphan Products Development grant award by the U.S. Food and Drug Administration (FDA).  The IIS will evaluate the expanded treatment, including up to 12 months of treatment, with HyBryte™ (synthetic hypericin) in patients with early-stage cutaneous T-cell lymphoma (CTCL). The trial is sponsored by Ellen Kim, MD, Director, Penn Cutaneous Lymphoma Program, Vice Chair of Clinical Operations, Dermatology Department, and Professor of Dermatology at the Hospital of the University of Pennsylvania who was a leading enroller in the recently published positive Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study in the treatment of early-stage CTCL.

“In the Phase 3 FLASH study, HyBryte™ was shown to be efficacious with a promising safety profile. CTCL patients are often searching for alternative treatments, with limited options especially for early-stage disease. HyBryte™ offers a distinct treatment option which patients found extremely useful and continue to specifically request. We look forward to demonstrating the expanded use of HyBryte™ in a “real world” setting and thank both the FDA and Soligenix for their support of this study,” noted Dr. Kim, principal investigator of the IIS, RW-HPN-MF-01.

“We are pleased the FDA is supporting the HyBryte™ program and giving patients an opportunity to access the therapy in an open-label setting,” stated Christopher J. Schaber, President and CEO of Soligenix, Inc. “CTCL is an incredibly difficult to treat orphan disease and remains an area of unmet medical need with a very limited number of safe and effective treatment options.

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