DMC recommends halting Ph 3 FLASH2 trial of HyBryt (Synthetic Hypericin) in the treatment of CTCL patients post interim efficacy analysis
“We are obviously very disappointed with the unanticipated outcome of the study,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. “Despite the fact that HyBryte™ demonstrated statistically significant reductions in CTCL 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 (EMA) and the U.S. Food and Drug Administration (FDA).”
Share:
More News
“FDA clearance of the IND for ORM-1153 is an important milestone for Orum, bringing another first-in-class DAC into the clinic and extending our approach into CD123-expressing hematologic malignancies,” said Olaf Christensen, M.D., Chief Medical Officer of Orum Therapeutics. “By combining cell-selective delivery with targeted protein degradation in a single molecule,
“We are excited to expand our clinical collaboration with Roche to evaluate a second KRAS combination with potential best-in-class MTA-cooperative PRMT5 inhibitor IDE892 for pancreatic cancer patients, where there remains a high unmet medical need. IDEAYA is advancing multiple rational combination strategies for the IDE892 program, including with MAT2A inhibitor
“These encouraging initial safety observations represent an important first step in the clinical evaluation of ZI-MA4-1 and our TCR-NK platform” said Namir Hassan, Chief Executive Officer of Zelluna. “The first patient received all three planned doses, and the independent committee’s recommendation enables us to continue recruitment at the first dose
“Receiving FTD is an important milestone for ERAS-0015 and reflects the urgent need for new therapies for patients with metastatic pancreatic cancer,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. “Together with the encouraging clinical activity and favorable tolerability observed to date, this FTD helps to position us