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CEL-SCI CORPORATION Manufacturing Facility for Pivotal Phase III Cancer Trial Scheduled to Be Completed During 2008 Third Quarter
Date:6/4/2008

and ultimately the licensing of Multikine for sale. Recent issues faced by Genzyme with its approval for Myozyme for Pompe's disease highlight again the need to run the pivotal Phase III clinical trial with drug that is manufactured in the same facility as the one the company will use for drug for sale."

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

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 in 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 Phase III trial and subsequent sale following approval.

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 sev
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SOURCE CEL-SCI CORPORATION
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