- Israel-based Enlivex Therapeutics ( NASDAQ: ENLV ) on Wednesday said it had got approval from French and Belgian regulatory agencies to expand its phase two sepsis trial into those countries.
- ENLV is conducting a mid-stage trial which is evaluating its cell therapy Allocetra in patients with sepsis.
- The French Agency for Food, Environmental and Occupational Health and Safety and the Belgian Federal Agency for Medicines and Health Products cleared the amended protocol of the trial, ENLV said in a statement .
- The approved protocol, which had previously got clearances in Israel, Greece and Spain, allows the treatment of newly recruited patients with a frozen Allocetra formulation as well as an expansion of the study's target population.
- ENLV stock was up 1.5% to $4.16 in early trade.
For further details see:
Enlivex gets French and Belgian regulatory nod to expand mid-stage sepsis trial