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."