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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
Date:10/7/2008

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 the
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SOURCE CEL-SCI Corporation
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