Enlivex Announces Regulatory Clearance in Multiple Countries for Integration of Frozen Allocetra Formulation and Expansion of Patient Population in its Sepsis Phase II Clinical Trial
Enlivex expects that broad acceptance of the proposed amendments will shorten the timeline for potential regulatory approval of frozen Allocetra formulation in sepsis and its associated commercial launch.
- Enlivex expects that broad acceptance of the proposed amendments will shorten the timeline for potential regulatory approval of frozen Allocetra formulation in sepsis and its associated commercial launch.
- In addition, the frozen formulation of Allocetra is expected to have a shelf-life spanning multiple years, versus a shelf life of 96 hours for the previously used liquid formulation.
- We are better positioned to build on our positive Phase Ib results and accelerate the advancement of our sepsis program, said Oren Hershkovitz, Ph.D., CEO of Enlivex.
- Enlivexs Phase II sepsis trial is a placebo-controlled, randomized, dose-finding, multi-center study that is currently enrolling patients across four cohorts.