Multikine leukocyte interleukin injection: Phase III hold

Cel-Sci said it received verbal notice from FDA that the agency placed a clinical hold on an open-label, international Phase III trial comparing Multikine plus standard of care (SOC) vs. SOC alone. Cel-Sci said patients who are receiving study treatments may continue treatment. The trial has enrolled 926 patients. According to ClinicalTrials.gov, the trial planned to enroll 880 patients. SOC comprises surgery plus radiotherapy or surgery plus concurrent radiochemotherapy. The company, which made the announcement on Sept. 26, expects a formal letter from FDA within 30 days. Cel-Sci declined to disclose details.

Ergomed is contributing up to $12 million towards the Phase III trial under a 2013 deal. The company is eligible to receive 4 times the amount it dedicates to development in the form of a 5% royalty ...