CEL-SCI Corporation recently announced that no further patient enrollment is required in the pivotal Phase 3 head and neck cancer study of its investigational immunotherapy, Multikine. The accrual and treatment phases of this Phase 3 study are complete. 928 patients are enrolled in the study, and are being followed-up as required by the study protocol. In addition, the company also recently announced that the study’s Independent Data Monitoring Committee (IDMC) completed its most recent review of the data from all 928 patients enrolled in the study, and recommended continuing the study as there was no evidence of any significant safety questions. IDMCs are committees used by sponsors of clinical trials to protect the interests of the patients and the integrity of the study data in ongoing trials, especially when the trials involve patients with life threatening diseases, and when, as in cancer clinical trials, they extend over long periods of time.
The primary endpoint of the study is a 10% improvement in overall survival of the Multikine treatment regimen, along with comparing the treatment regimen and Standard of Care (SOC) versus Standard of Care alone. This will be determined after a total of 298 deaths have occurred in these two main comparator arms of the study and have been recorded in the study database. The last patient was enrolled in the study in September 2016. Approximately 135 patients were enrolled in the study from 2011 to 2013, about 195 were enrolled in 2014, about 340 in 2015, and about 260 in 2016. There was a survival rate of about 55% at 3 years for the Standard of Care treatment group alone.
CEL-SCI is a Phase 3 cancer immunotherapy company that believes it is most logical to boost the patient’s immune system while it is still intact in order to have the greatest possible impact on survival. Therefore, CEL-SCI treats patients who are newly diagnosed with head and neck cancer with Multikine before they have received surgery, radiation or chemotherapy. This approach is unique; most other cancer immunotherapies are used only after conventional therapies have been tried and failed. Head and neck cancer represents about 6% of all cancers. Multikine has received Orphan Drug designation from the FDA for the treatment of head and neck cancer patients with advanced squamous cell carcinoma. CEL-SCI has operations in Vienna, Virginia, and in Baltimore, Maryland.
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