CEL-SCI has reached the full enrolment stage in a Phase lll trial of its investigational immunotherapy Multikine (Leukocyte Interleukin, injection) for the treatment of head and neck cancer.
The company has also completed the accrual and treatment phases of the trial, which includes 928 patients.
The enrolled patients are currently being followed-up in accordance with the study protocol.
CEL-SCI noted that the study enrolled around 135 patients from 2011 to 2013, approximately 195 in 2014, 340 in 2015, and 260 patients in 2016.
The study's primary objective is to achieve a 10% improvement in overall survival of the Multikine treatment regimen plus standard of care (SoC) vs standard of care alone.
In addition, the study protocol assumed an overall survival rate of nearly 55% at three years for the SoC treatment group.
Earlier this month, the study’s independent data monitoring committee (IDMC) completed its latest review of the data from all the enrolled patients and recommended continuing the study as there was no evidence of any significant safety questions.
IDMCs are usually employed by sponsors of clinical trials to protect the interests of the patients and the integrity of the study data in ongoing trials.
They will be employed especially during the time when trials are related to patients with life-threatening diseases, and when they are prolonged as in cancer clinical trials.