Safety board clears LyGenesis ectopic-liver trial to escalate dose after first four patients

LyGenesis/LYG-LIV-001 ectopic liver

The trial's Data and Safety Monitoring Board reviewed safety, tolerability and efficacy data from the first cohort of four patients and recommended continuing at a higher dose for the next four. Principal investigator Constance Mobley of Houston Methodist said the team was very encouraged by the therapy's safety and tolerability so far.

• 12 patients planned in cohorts of four; each followed for one year.
• Cells are injected via endoscopic ultrasound into upper abdominal lymph nodes; not genetically engineered.
• Up to half of end-stage liver patients are medically ineligible for transplant; about 12% of wait-listed patients die each year.
• No dose levels or efficacy numbers were released.