SNGX News & Events

"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 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.