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CEL-SCI Presents Long-Term Cancer Survival Data With Multikine

(FDA) to proceed to a Phase III clinical trial with Multikine earlier this year. The same treatment regimen that was used in CEL-SCI's final Phase II trial will be used in the upcoming Phase III trial that CEL-SCI will undertake since the results obtained in the final Phase II trial are thought to be indicative of the results one might expect in any Phase III trial of Multikine. The Phase III trial is designed to demonstrate a 10% increase in overall survival of patients treated with adjuvant Multikine therapy versus those treated only with the current standard of care.

Dr. Talor said, "Having shown a 33% increase in overall survival with no safety concerns in the final Phase II study, we are very hopeful that we will successfully reach the 10% increase in overall survival that is the primary endpoint of our Phase III trial. To further enhance the probability of meeting our primary endpoint, we are over-enrolling the study."

Documented data were available for 19 of the 22 patients in the follow-up portion of this clinical trial. Of the three patients who could not be evaluated in the follow-up study, one patient was known to be alive, but failed to give informed consent, and the other two were lost to follow-up. One patient died the day after definitive surgery, unrelated to Multikine therapy.

Head & neck cancer is an aggressive cancer that affects over 500,000 - 600,000 people per annum worldwide.

CEL-SCI Corporation is developing new immune system based treatments for cancer and infectious diseases. The Company has received the go-ahead from the U.S. FDA and the Canadian Regulators to conduct a Phase III clinical trial in advanced primary head and neck cancer patients with its lead product Multikine. CEL-SCI's other products, which are currently in pre-clinical stage and have been funded with U.S. government support, have shown protection against a number of diseases in animal tests and are currently being tested against diseases a
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