Soligenix updates medical advisory board for lymphoma drug development
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Soligenix Inc. (NASDAQ: SNGX) announced it has updated its United States Medical Advisory Board for cutaneous T-cell lymphoma to provide guidance as the company advances Phase 3 clinical development of HyBryte, its synthetic hypericin treatment for the rare form of non-Hodgkin's lymphoma.
The advisory board comprises dermatologic and oncologic specialists with experience in cutaneous T-cell lymphoma who have participated in the HyBryte clinical program as principal investigators. The board has provided input on the ongoing FLASH2 Phase 3 study and will continue to advise on regulatory interactions with health authorities worldwide.
The updated board includes Dr. Jennifer DeSimone from the University of Virginia INOVA Fairfax Campus, Dr. Youn Kim from Stanford University School of Medicine, Dr. Aaron Mangold from Mayo Clinic Arizona, and Dr. Brian Poligone from Rochester Skin Lymphoma Medical Group, who serves as chair.
"Many of the MAB members have experience treating patients with HyBryte and have been invaluable to the program," stated Christopher J. Schaber, president and chief executive officer of Soligenix.
HyBryte is a photodynamic therapy that uses visible light for activation. The treatment involves topical application of synthetic hypericin to skin lesions, which is then activated by visible light approximately 24 hours later.
The company's first Phase 3 FLASH trial showed 16% of patients receiving HyBryte achieved at least a 50% reduction in lesions compared to 4% in the placebo group. The ongoing FLASH2 study is designed to replicate these results with continuous 18-week treatment.
Cutaneous T-cell lymphoma affects approximately 31,000 individuals in the United States and 38,000 in Europe, according to the company's estimates based on epidemiological data.
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