Business
Soligenix's HyBryte(TM) Treatment Now Within Reach for Rare Cancer Patients
HyBryte(TM) NDA Anticipated in H2 2022 New York, New York--(Newsfile Corp. - July 26, 2022) - PCG Digital -- Late-stage biopharmaceutical company, Soligenix,
About this update from Soligenix, Inc.
[{"type":"text","content":"HyBryte(TM) NDA Anticipated in H2 2022\nNew York, New York--(Newsfile Corp. - July 26, 2022) - PCG Digital -- Late-stage biopharmaceutical company, Soligenix, Inc. (NASDAQ: SNGX), has completed the largest placebo controlled, randomized Phase 3 trial ever done in cutaneous T-cell lymphoma (CTCL) evaluating a novel topical treatment for early-stage CTCL and is preparing to submit a New Drug Application to the FDA to commercialize the product.\n\n\nSoligenix, Inc.\nTo view an enhanced version of this graphic, please visit:\nhttps://images.newsfilecorp.com/files/6513/131925_a1e432df44222bd3_001full.jpg.\nCutaneous T-Cell lymphoma (CTCL) is a rare cancer that affects approximately 27,000 Americans. It has no cure and as a chronic condition must be managed by patients and their doctors over years, and sometimes decades. Today, most treatment options for CTCL are associated with significant safety concerns.\nSoligenix's treatment, HyBryte™, has been evaluated through Phase 1, 2 and 3 clinical trials and has been found to be safe and well-tolerated, and to significantly reduce CTCL lesion size. It also has an advantage over traditional phototherapy, which uses DNA-damaging ultraviolet (UV) light. HyBryte™ (topical synthetic hypericin), is applied directly to the cancerous skin lesions followed by activation with safe, visible fluorescent light, so the risk of developing actinic skin damage and skin cancers is not a concern as it is with UV light. Short term side effects are also less common and milder than those usually found in traditional phototherapy.\nIt is an exciting time for CTCL patients, who may soon have access to a safer and more effective treatment option. We caught up with Dr. Richard Straube, Soligenix's Chief Medical Officer, to find out more about HyBryte and the clinical journey to date.\nQ: Can you tell us about HyBryte™ and how it works?\nA: HyBryte™ is an ointment that delivers a drug called synthetic hypericin. We apply it topically on the skin on the lesions that are seen in CTCL. After the drug is absorbed by the cancer cells, which takes about 24 hours, we shine a fluorescent light on the affected areas. That in turn kills the cancer cells.\nQ: You've been involved in many clinical trials over the years. Is there anything about the HyBryte trials that stands out?\nA: Certainly. The Phase 3 study undertaken by So...