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CEL-SCI Enters Agreement With National Institutes of Health Clinical Center To Determine the Molecular Basis of Multikine Anti-Tumor Effect

October 7, 2008

VIENNA, Va., Oct. 7 /PRNewswire-FirstCall/ — CEL-SCI Corporation announced today that it has entered into a Material Transfer Agreement (MTA) with the National Institutes of Health Clinical Center (NIHCC) and the laboratory of Dr. Francesco M. Marincola, M.D., to investigate the molecular basis of changes to the tumor microenvironment caused by CEL-SCI’s cancer drug Multikine. Dr. Marincola is the Chief of the Infectious Disease and Immunogentics Section, Department of Transfusion Medicine Clinical Center, National Institutes of Health, a leading national and international medical research laboratory.

Pursuant to the agreement, CEL-SCI will provide tumor samples of Multikine treated and untreated matched control patients to the NIHCC, which will then use the latest molecular genomic microarray technology developed by Dr. Marincola’s laboratory to look for molecular genomic differences in the tumor microenvironment in patients with squamous cell carcinoma of the head and neck. Should these pre-clinical experiments find significant differences between the Multikine treated and untreated patients, a formal collaboration between CEL-SCI and the NIHCC may be developed in order to expand the study to include patients from CEL-SCI’s Pivotal global Phase III clinical trial.

“Multikine’s potential to change the tumor microenvironment and, in doing so, break tumor tolerance has been a long-time goal of anti-cancer immunotherapy. We are very excited to be working with Dr. Marincola and the NIH Clinical Center to determine the molecular basis of Multikine’s ability to cause tumor microenvironment changes,” said Dr. Talor, Senior VP of Research and Manufacturing at CEL-SCI and the developer of Multikine.

About CEL-SCI’s Phase III Cancer Drug Multikine:

CEL-SCI is developing Multikine for approval as a first-line indication in head and neck cancer. The company’s upcoming Pivotal global Phase III clinical trial is an 800 patient study designed to demonstrate that administration of its anti-cancer drug Multikine to head and neck cancer patients before they receive their first conventional cancer treatment will increase their survival. Head and neck cancer is one of the world’s biggest cancers affecting about 650,000 people per annum.

In Phase II clinical trials Multikine was shown to be safe and well-tolerated, and to improve the patients’ overall survival by 33% at a median of three and a half years following surgery. The U.S. Food and Drug Administration (FDA) gave the go-ahead for a Phase III clinical trial with Multikine in January 2007 and granted orphan drug status to Multikine for the neoadjuvant therapy of squamous cell carcinoma (cancer) of the head and neck, in May 2007. In the summer of 2007 CEL-SCI started construction of the manufacturing facility to produce Multikine for the global Phase III trial and subsequent sale following approval. This facility is expected to be completed soon.

Multikine, a patented defined mixture of naturally derived cytokines is the first immunotherapeutic agent in a new class of drugs called “Immune SIMULATORS.” Immune SIMULATORS simulate the way our natural immune system acts in defending us against cancer. As opposed to other immunotherapies which are designed to target a single or limited number of specific antigens or molecules, Immune SIMULATORS are multi-targeted; they simultaneously cause a direct and targeted killing of the specific tumor cells and they activate the immune system to produce a stronger anti-tumor attack on multiple fronts.

Multikine is also the first immunotherapeutic agent being developed as a first-line standard of care treatment for cancer. It is administered prior to any other cancer therapy because that is the period when the anti-tumor immune response can still be fully activated. Once the patient has advanced disease, or had surgery or has received radiation and/or chemotherapy, the immune system is severely weakened and is less able to mount an effective anti-tumor immune response. Other immunotherapies are administered after the patient has received chemotherapy and/or radiation therapy, which can limit their effectiveness.

The Company has operations in Vienna, Virginia and Baltimore, Maryland. CEL-SCI’s other products, which are currently in pre-clinical stage, have shown protection against a number of diseases in animal tests and are being tested against diseases associated with bio-defense.

NO ENDORSEMENT OF ANY ORGANIZATION, PRODUCT OR SERVICE MENTIONED IN THIS ARTICLE IS INTENDED OR INFERRED BY THE NATIONAL INSTITUTES OF HEALTH OR ITS EMPLOYEES.

CEL-SCI Corporation

CONTACT: Gavin de Windt of CEL-SCI Corporation, +1-703-506-9460

Web site: http://www.cel-sci.com/




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