VIENNA, Va., Dec. 6 /PRNewswire-FirstCall/ -- On December 5, 2005, CEL-SCI CORPORATION announced that it had signed a Cooperative Agreement with the National Institute of Allergy and Infectious Diseases (NIAID), an institute of the National Institutes of Health of the U.S. government, to test CEL-SCI's patented anti-infective drug CEL-1000 against the avian (bird) flu virus H5N1 in animal models. The testing will be conducted to determine whether CEL-1000 could be used as a potential treatment and/or preventive agent against this virus.
The December 5th release has resulted in a number of questions from shareholders and the media. Since the questions are fairly uniform, CEL-SCI will attempt to answer them in this release.
1) Who will pay for the tests? The NIH will pay for the tests. 2) If the tests are successful, what will come next? That determination will be made at that point in time and is not covered by the current agreement. 3) Will supply of CEL-1000 delay the testing? No, CEL-SCI currently has adequate amounts of CEL-1000 available for testing. 4) Is manufacturing of this product for the tests and/or potential sale of the product a problem? No, we have CEL-1000 on hand to do the current testing. CEL-1000 is produced for CEL-SCI by contract manufacturers. There are several capable contract manufacturers who could produce and formulate CEL-1000 into a drug product that meets all of the required regulations. 5) You state that CEL-1000 is related to your L.E.A.P.S.(TM) technology which requires a different antigen for each disease. Does CEL-1000 require the avian flu antigen? No, the great attraction of CEL-1000 in this case is that it has previously been shown to protect animals against viruses and unrelated diseases without a specific antigen. In all of these tests, the same peptide was used. It is this lack of specificity that makes CEL-1000 such an attractive potential therapy against the changing avian flu virus. 6) How do you envision that your product could potentially be used against the avian flu? We envision three potential applications. One, as a preventive, since CEL-1000 was shown to be 100% protective in animal challenge studies against viruses and unrelated diseases. Two, as a treatment. Three, as an adjuvant to enhance the immune response to the current avian flu vaccine being made. There is a clear need to reduce the amount of antigen required for an immune response per person since the current facilities cannot produce anywhere close to the amount of vaccine required. The addition of an adjuvant to the vaccine should allow for a larger number of vaccine doses with the same amount of antigen which would expand substantially the number of persons who could be vaccinated with a protective dose. 7) Why do you think that CEL-1000 might work against the avian flu virus? CEL-1000 appears to activate innate (very early stage) and Th1 type (cellular) immune responses to induce a broad-spectrum protection against infection in animal models. The innate immune system is generally accepted to be the first line of defense against infectious agents. We believe that activating innate immunity might also help against the avian flu virus.
CEL-1000, derived from the beta chain of human MHC-II, is a modified version of a human immune-based protein known to bind to both human and mouse immune cells and appears to act by enhancing the host's protective immune response.
The National Institutes of Health (NIH) -- The Nation's Medical Research Agency -- includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary Federal agency for conducting and supporting basic, clinical, and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases.
CEL-SCI Corporation is developing new immune system based treatments for cancer and infectious diseases. The Company has operations in Vienna, Virginia and Baltimore, Maryland.
When used in this report, the words "intends," "believes," "anticipated" and "expects" and similar expressions are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties which could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include, an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI Corporation's SEC filings, including but not limited to its report on Form 10- K for the year ended September 30, 2004. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
CEL-SCI CorporationCONTACT: Gavin de Windt of CEL-SCI Corporation, +1-703-506-9460; InvestorRelations, Mike Lucci of Lucci Financial Group, LLC, +1-248-723-3330
Web site: http://www.cel-sci.com//
