CEL-SCI Corporation has announced positive results from a long-term follow-up study of head & neck cancer patients treated with its drug Multikine in a Phase II clinical trial.

The follow-up study indicated that Multikine treatment resulted in a substantial increase in the survival of patients. In addition, Multikine treatment also improved local regional control of the patients’ tumors. Improved local regional control of the tumor is considered by many surgeons and oncologists to be an important measurement of the success of a head & neck cancer drug. Both survival and local regional control of the tumor are stated endpoints in CEL-SCI’s planned Phase III clinical trial.

The Phase II study, which used the same Multikine treatment protocol as proposed for the Phase III trial, included advanced primary head & neck cancer patients who were scheduled for their first cancer treatment. The Multikine treatment was administered for 3 weeks prior to the standard treatment for head & neck cancer, surgery or surgery plus radiation/chemotherapy. Results from this study were published in a leading cancer publication, the Journal of Clinical Oncology (Timar et al, JCO, 23(15): May 2005).

The median follow-up period for the patients was 3.2 years. The results of the Phase II trial follow-up study showed that the Multikine-treated patients had substantially increased survival rates and achieved a higher rate of 2-year local regional control as compared to the survival and the 2-year local regional control rates published in the scientific literature (39 clinical trials between 1987 and 2004 in a similar population of head & neck cancer patients). At this time, CEL-SCI cannot provide the detailed results of this long-term follow-up study of Multikine treatment as the data are currently being prepared for publication.

Maximilian de Clara, President of CEL-SCI, states, “These results suggest that Multikine has the potential to bring much needed benefit to patients with head & neck cancer, a disease that has significant morbidity and mortality and for which there has been little improvement in therapy over the last 20 years. We are very excited by these results and hope to repeat these very promising results in our Phase III clinical trial.”

CEL-SCI received the go-ahead for its proposed Phase III trial from the Canadian drug regulatory authority in August 2005. The same proposed Phase III trial was submitted to and discussed with the United States Food and Drug Administration (FDA) in two separate End of Phase II meetings held during 2005. Following each of these meetings the FDA requested that additional information be provided. CEL-SCI has recently completed the submission of all of the additional information the FDA requested and awaits the FDA’s response.

Head and neck cancer is an aggressive cancer that affects about 500,000 people per annum worldwide. About 92% of those cases are outside of the U.S., and about two thirds of all cases present with advanced disease.

Multikine is a patented immunotherapeutic agent consisting of a mixture of naturally occurring cytokines, including interleukins, interferons, chemokines and colony-stimulating factors, currently being developed for treatment of cancer.

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