VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (NYSE AMEX: CVM) announced today it has received approval from the North Mississippi Health Services (“North Mississippi”) Institutional Review Board (“IRB”) 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’s Phase III clinical trial is an open-label, randomized, multi-center study designed to determine if Multikine administered prior to current standard of care (Surgery plus Radiotherapy or Surgery plus Concurrent Chemo radiotherapy) in 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. North Mississippi is the first site in the United States to approve enrollment of subjects. 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.
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. Follow-up studies of subjects enrolled in Phase II trials showed a 33% improvement in the survival rate of those treated with Multikine at a median of three and a half years following surgery. The U.S. Food and Drug Administration gave clearance for a Phase III clinical trial and granted orphan drug status to Multikine in the neoadjuvant therapy of patients with squamous cell carcinoma of the head and neck.
About North Mississippi Health Services
North Mississippi Health Services (NMHS) is a diversified regional health care organization, which serves 24 counties in north Mississippi and northwest Alabama from headquarters in Tupelo, Mississippi. The NMHS organization covers a broad range of acute diagnostic and therapeutic services, offered through North Mississippi Medical Center in Tupelo; a community hospital system with locations in Eupora, Iuka, Pontotoc, West Point, Miss. and Hamilton, Alabama, North Mississippi Medical Clinics, a regional network of more than 30 primary and specialty clinics; and nursing homes. NMHS has an IRB that meets monthly. The NMHS IRB members include doctors, nurses, pharmacists, social workers, a lawyer, risk manager, and community members. This group reviews the science and ethics of the research. Their objective is to assess the risks and benefits to subjects involved in the study. The NMHS IRB has the authority to approve, require modification to, or disapprove all research activities that involve an NMHS investigator, facility, or patient group. Following initial approval, the IRB conducts periodic reviews of such research. In most instances, in order to approve research, an IRB must determine that specified criteria have been satisfied. Among these criteria, an IRB must determine that, when appropriate, the research protocol includes "adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data."
About CEL-SCI Corporation
CEL-SCI Corporation is developing products that empower immune defenses. Its lead product is Multikine. In Phase II clinical trials Multikine was shown to be safe and well-tolerated, and to improve the patients' overall survival by 33 percent at a median of three and a half years following surgery. A pivotal Phase III clinical trial with Multikine in head and neck cancer is expected to start in the second half of 2010.
CEL-SCI is also developing an immunotherapy (LEAPS-H1N1-DC) to treat H1N1 hospitalized patients and a vaccine (CEL-2000) for Rheumatoid Arthritis using its LEAPS technology platform. The LEAPS-H1N1-DC treatment involves non-changing regions of H1N1 Pandemic Flu, Avian Flu (H5N1), and the Spanish Flu as CEL-SCI scientists are very concerned about the creation of a new more virulent hybrid virus through the combination of H1N1 and Avian Flu, or maybe Spanish Flu. This investigational treatment is being tested in a clinical study at Johns Hopkins University. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.
For more information, please visit www.cel-sci.com.
CONTACT:
CEL-SCI Corporation
Gavin de Windt, 703-506-9460
KEYWORDS: United States North America Mississippi Virginia
INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Oncology
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