CEL-SCI gets Israeli nod to commence phase III trial of multikine in head and neck cancer
Source: www.pharmabiz.com Author: staff CEL-SCI Corporation announced that the State of Israel's Ministry of Health has given approval to begin enrolment of subjects for a phase III clinical trial of Multikine in Israel. Israel is one of nine countries to participate in this global phase III trial. The phase III trial will be conducted in approximately 48 clinical centres. CEL-SCI's partner Teva Pharmaceutical Industries will be conducting the trial at three clinical centers in Israel. The phase III trial started in the United States in late December 2010 and is expected to commence in other countries around the world within the next 30-60 days. Multikine is the company's flagship immuno-therapy developed as a first-line standard of care in treating head and neck cancer. CEL-SCI's phase III clinical trial is an open-label, randomized, controlled, multi-centre study designed to determine 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. CEL-SCI's 880 patient phase III trial is expected to be the largest clinical study of head and neck cancer ever conducted. It is also the first trial in which immunotherapy will be administered before any other traditional means of care are attempted. This is significant because conventional cancer therapy weakens the immune system and likely compromises the [...]