CEL-SCI Receives Approval to begin Phase III Trial of Multikine in India Print E-mail
By Staff and Wire Reports   
Wednesday, 20 October 2010 08:55
CEL-SCI Corporation (AMEX: CVM), the company which is developing products that empower immune defenses, announced today it has received approval from seven hospital Institutional Review Boards (“IRB”) in India to begin enrollment of subjects for a Phase III clinical trial of Multikine®, the Company’s flagship immunotherapy developed as a first-line standard of care in treating head and neck cancer. An IRB is a group formally designated by an institution to review and monitor research involving human subjects and to ensure protection of their rights and welfare. CEL-SCI expects to have fifteen clinical centers in India, out of an expected forty-eight clinical centers world-wide. Head and neck cancer is the most prevalent form of cancer in India with about 200,000 new patients annually.

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Since mid last month, the company has been issuing press releases announcing similar developments in other counties such as Taiwan, Hungary, Russia and others. CEL-SCI’s trial will be conducted in nine countries and is expected to be the largest clinical study of head and neck cancer ever conducted. It will also be the first trial in which immunotherapy will be administered before any other traditional means of care are attempted. CEL-SCI plans to announce additional site approvals and country approvals as they become known.

Last year, the company financed and finished building a $25 million state-of-the-art manufacturing facility which will produce the highly specialized drug.

CEL-SCI’s Phase III clinical trial is an open-label, randomized, multi-center study. North Mississippi Health Services was the first site in the United States to approve enrollment of subjects.

Investors are monitoring the developments closely as Phase II clinical trials of Multikine demonstrated the product was safe and well-tolerated and eliminated tumors in 12% of the subjects less than a month into treatment. The 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.

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