CEL-SCI Corporation (AMEX: CVM) is a pioneer in biotechnology research. We develop novel drugs for the treatment of cancer and infectious diseases. Our lead product, Multikine®, is designed to improve first line therapy for the treatment of head & neck cancer. The concept behind Multikine is to harness the power of the immune system against cancer. Multikine is a biologic comprised of cytokines that stimulate the human immune system to overcome tumor tolerance.
Highlights:
Multikine is cleared in Canada for a Phase III clinical trial designed to improve 1st line therapy for advanced primary head & neck cancer. CEL-SCI has submitted the same Phase III protocol to the U.S. Food & Drug Administration (FDA) and hopes for FDA concurrence in 2006.
Head & neck cancer accounts for 5% of all cancers worldwide, with 500,000 new cases each year. The potential market exceeds $1 billion.
Phase II results were published in May 2005 in the leading U.S. cancer journal, Journal of Clinical Oncology (ASCO) Vol. 23, No. 15.
CEL-SCI's Asian partner, Orient Europharma, will either be running a separate Phase III study with Multikine in head & neck cancer or, most likely, will share the costs of the Phase III study with CEL-SCI. The Far East has a very large number of head & neck cancer patients.
Multikine is the only product being developed for 1st line therapy of advanced primary head & neck cancer (the largest market). All other products in development are being developed for recurrent or late stage head & neck cancer.
CEL-SCI's other patented technology called L.E.A.P.S.™, and its lead candidate CEL-1000, have enjoyed significant government funding as well as collaborations with the U.S. Navy, U.S. Army and National Institutes of Health (NIH). CEL-1000 has been shown to protect against viruses and parasitic diseases in animals.
In December 2005, CEL-SCI signed an agreement with the National Institute of Allergy and Infectious Diseases (NIAID) to test CEL-1000 against the avian (bird) flu virus H5N1 in animal models.