Enlivex Announces Authorization from the Danish Regulatory Agency for the Company’s Randomized, Controlled Phase I/II Trial Evaluating Allocetra in Patients with Knee Osteoarthritis
As previously announced, the Company received its first regulatory approval for this trial from the Israeli Ministry of Health (IMOH) in January.
- As previously announced, the Company received its first regulatory approval for this trial from the Israeli Ministry of Health (IMOH) in January.
- The Phase I/II multi-center trial is composed of two stages.
- In addition to evaluating safety, the blinded randomized stage is statistically-powered to assess the efficacy of Allocetra™ injections into the knee.
- Oren Hershkovitz, Ph.D., CEO of Enlivex, commented “We are excited to push ahead with the clinical development of AllocetraTM in osteoarthritis.