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SNGX 資訊
SNGX 事件
Soligenix Disappointed with FLASH2 Study Results
"We remain disappointed with the unanticipated outcome of the FLASH2 study," stated Christopher Schaber, PhD, President and CEO of Soligenix. "Despite the fact that HyBryte demonstrated statistically significant reductions in cutaneous T-cell lymphoma lesions after 6 weeks treatment in the first FLASH study, a similar signal was not observed with 18 weeks of treatment in this study. Over the coming weeks, we will analyze the data to better determine why the study did not meet expectations. If there is any clarity gained from further analysis of the dataset, especially with respect to specific subsets of patients that may benefit from HyBryte therapy, then we intend to communicate our findings and explore follow-up discussions with the European Medicines Agency and the Food and Drug Administration."
Soligenix HyBryte Study Shows Efficacy Over Valchlor
Soligenix announced today that the positive results of its comparability study evaluating HyBryte - synthetic hypericin - versus Valchlor - mechlorethamine - for the treatment of cutaneous T-cell lymphoma, or CTCL, have been published in Oncology and Therapy. The purpose of the study was to obtain preliminary comparative assessment of the safety and efficacy of HyBryte vs. Valchlor following 12 weeks of treatment as measured in 3 to 5 prospectively identified index lesions for each patient. At the end of the 12-week treatment period, 60% of the HyBryte patients met the prospectively defined level of "Treatment Success" - greater than or equal to50% improvement in their cumulative mCAILS score compared to Baseline - vs. only 20% of the Valchlor patients; although due to the small sample size the results do not achieve statistical significance. Of the remaining two HyBryte patients that did not achieve treatment success, both saw a substantial reduction in their mCAILS score. In contrast, in the Valchlor group, of the remaining 4 patients that did not achieve treatment success, one worsened and dropped from the study, one improved less than 30% and two improved greater than 30%. The average cumulative improvement in mCAILS at 12 weeks was 52.5% in the HyBryte patients versus 34.7% in the Valchlor patients. HyBryte was well tolerated in all patients. All patients tolerated HyBryte well and had no adverse events "related" to the therapy vs. 60% of the Valchlor treated patients had at least one adverse event "related" to the therapy.
Soligenix Receives EMA Orphan Drug Designation for SGX945
Soligenix announced that the European Commission, acting on the positive recommendation from the European Medicines Agency Committee for Orphan Medicinal Products, has granted orphan drug designation to dusquetide, the active pharmaceutical ingredient in SGX945, for the treatment of Behcet's Disease, following review of the recently published Phase 2a clinical results demonstrating biological efficacy and safety in patients with Behcet's Disease. SGX945 has previously been granted both orphan drug and fast track designations from the FDA for the treatment of Behcet's Disease. Orphan drug designation by the EMA provides a 10-year period of marketing exclusivity in the EU after product approval. Orphan designation also provides incentives for companies seeking protocol assistance from the EMA during the product development phase, and direct access to the centralized authorization procedure.
Soligenix Publishes Summary of HyBryte Clinical Trials
Soligenix announced today that a summary of all the clinical trials completed to date evaluating HyBryte as a treatment for cutaneous T-cell lymphoma has been published in the peer-reviewed medical journal Expert Opinion on Investigational Drugs. The publication "Topical Hypericin: A Promising Photodynamic Therapy for Early-Stage Cutaneous T-Cell Lymphoma" is authored by Brian Poligone, MD, PhD, the founder and Medical Director of the Rochester Skin Lymphoma Medical Group and the Director of Cancer Biology Research for the Rochester General Hospital Research Institute who has extensive clinical experience evaluating HyBryte with his team's participation in four HyBryte clinical studies. "We are pleased to have Dr. Poligone and his team review the compelling data generated from the HyBryte(TM) clinical program, enabling the medical community to evaluate its safety, efficacy and utility in early-stage CTCL," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We look forward to continuing our work with Dr. Poligone and all our principal investigators as we move towards completing patient enrollment in the FLASH2 Phase 3 study later this year, with an interim analysis of this study expected in 2Q 2026."
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