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Phase 3 Trial Protocol Submitted to FDA for Investigational Immunotherapy Drug Multikine

VIENNA, Va., Jan. 4 /PRNewswire-FirstCall/ -- CEL-SCI CORPORATION (Amex: CVM) has submitted a Phase III clinical trial protocol to the U.S. Food and Drug Administration ("FDA") for the use of its investigational immunotherapy drug Multikine(R) in the treatment of advanced primary squamous cell carcinoma of the oral cavity. Additional information in support of and to provide the rationale for the Phase III trial (final reports of clinical trials conducted with Multikine to date and manufacturing and testing information) was included with this submission.

The protocol was designed in consultation with a group of recognized experts in the field of head & neck cancer therapy to develop the conclusive evidence of the safety and efficacy of Multikine in the treatment of advanced primary squamous cell carcinoma of the oral cavity that would be required to license the product. The Company plans to meet with the FDA to discuss the proposed Phase III clinical trial over the next several months and obtain the agency's approval to initiate the study.

Geert Kersten, Chief Executive Officer of CEL-SCI said, "We believe that Multikine has the ability to improve the success rate of first line therapy in head & neck cancer and this protocol is designed to prove our belief."

Head and neck cancer is an aggressive cancer that affects about 500,000 people per annum worldwide.

Multikine is an immunotherapeutic agent consisting of a mixture of naturally occurring cytokines including interleukins, interferons, chemokines and colony-stimulating factors. Multikine has completed several Phase II clinical trials and has been tested in over 200 patients. It has been shown to be safe, to render cancer cells much more susceptible to radiation therapy (The Laryngoscope, December 2003, Vol.113 Issue 12), to reverse the ratio of CD4/CD8 immune cells in the tumor and to induce a 42% response rate, including a 12% total elimination of tumor as determined by pathology, following only 3 weeks of treatment (Proceedings of the 40th ASCO Annual Meeting, June 5-8, 2004).

Source: CEL-SCI CORPORATION

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