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news.The Directorate General of Health Services Office of Drug Controller General (India) has approved CEL-SCI to initiate patient recruitment in an open-label, randomized, controlled, multi-center Phase III clinical trial of Multikine in India.
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The global Phase III trial for Multikine was started in the US in late December 2010.
CEL-SCI expects to commence the trial in other countries around the world within the next 30-60 days.
The Phase III clinical trial is intended to establish if Multikine administered prior to current standard of care 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.
Earlier, the 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.