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news.CEL-SCI, a developer of products for immune defenses, has got The Polish Minister of Health approval to start patient recruitment in an open-label, randomized, controlled, multi-center Phase III trial evaluating Multikine in patients suffering from head and neck cancer.
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The trial is intended to establish if Multikine administered prior to current standard of care (surgery plus radiotherapy or surgery plus concurrent chemo radiotherapy) in previously untreated subjects with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity/Soft Palate (head and neck cancer) will result in an increased overall rate of survival, versus the subjects treated with standard of care only.
Phase II clinical trials of Multikine showed that the product was safe and well-tolerated and eliminated tumors in 12% of the subjects less than a month into treatment.
Additionally, Multikine treatment regimen was also shown to kill, on average, about half of the cancer cells in the subjects’ tumors before the start of standard therapy.