VIENNA, Va., April 3 /PRNewswire-FirstCall/ -- The following letter is being released by CEL-SCI CORPORATION to its shareholders:
Dear Fellow Shareholders:
On March 30, 2006 the New England Journal of Medicine (“NEJM”) published the results of the first human testing of a H5N1 bird flu vaccine. It showed that the vaccine, which was produced by the pharmaceutical giant Sanofi- Aventis, sparked a protective immune response in a disappointingly small percentage of vaccine recipients - 54 percent of those who received two shots, 28 days apart, of the highest dose tested. This dose was twelve times higher than that needed for protection by the “normal” human flu vaccine where protection rates are generally in the 80-90% range.
This study identifies 3 problems with this bird flu vaccine: 1) Each person requires so much vaccine that the government will not be able to build up the necessary stockpiles to protect the general population from the bird flu. 2) Only about half the people respond with the desired immune responses. 3) It takes a long time to produce an immune response during which time the person is not protected. We believe that our CEL-1000 product, when added to the bird flu vaccine, may be able to address all 3 problems.
CEL-1000, when used as a single adjuvant (enhancer of a vaccine) or in combination with other adjuvants, potentiates Th1 (cellular) and innate (earliest stage) immune responses and protects animals from viral and parasitic challenge. CEL-1000’s protection, upon challenge with the disease causing agent(s), provides antigen-independent (i.e., non-disease specific) and broad-spectrum protection, which is important against the bird flu virus since it exhibits a high mutation rate.
A critical need exists for a new class of adjuvant, such as CEL-SCI’s CEL- 1000, that enhances the immunogenicity of existing prophylactic bird flu vaccines and can therefore reduce the antigen dose required per person and increase the ultimate supply/availability of the vaccine. We think that CEL- 1000 will be able to do that, thereby addressing problems 1 and 2 listed above. We believe that CEL-1000 could replace common adjuvants such as Alum, or be used together with them.
As an additional benefit, since CEL-1000 is an immunomodulator that acts on the innate immune system, CEL-1000 could also facilitate immune protection until post-vaccination immunity can be established. This use would be especially beneficial for individuals who are at high risk, such as healthcare and poultry workers. The study published in NEJM showed that at least 2 vaccinations, 4 weeks apart, are required to establish a protective immune response in vaccine recipients. That means that a person is not protected for about 5-6 weeks after the first vaccination, a long time during a life- threatening epidemic. Since CEL-1000 works on the earliest stage of the immune system and has been shown to protect against a number of viruses and parasitic diseases in animals, it stands to reason that CEL-1000 could provide the necessary “stop-gap immunity” until specific protection can be obtained from the bird flu vaccine. This would address problem 3.
In December 2005, CEL-SCI signed an agreement with the National Institute of Allergy and Infectious Diseases (NIAID), whereby NIAID agreed to test CEL- 1000 as a possible vaccine or treatment against bird flu virus H5N1 in its animal models of the disease. The protocol for the first test was recently decided upon. In addition, we are in contact with a number of pharmaceutical and biotech companies to allow them to test CEL-1000 in their bird flu testing models as an adjuvant for a bird flu vaccine. If we are right, CEL-1000 could make a huge difference in having a successful vaccine against bird flu.
CEL-1000’s mechanism of action: CEL-1000 is a defined peptide which binds to the CD4 and/or likely a related molecule LAG-3 on dendritic cells, macrophages and T cells, thereby promoting the release of cytokines responsible for activating a protective Th1 immune response (e.g., IL-12 and upon challenge IFN-gamma.).
We thank you for your support. Sincerely, Geert Kersten Maximilian de Clara Chief Executive Officer President
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/A 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 Corporation
CONTACT: Gavin de Windt of CEL-SCI Corporation, +1-703-506-9460; orInvestor Relations, Michael Lucci, Jr. of Lucci Financial Group, LLC,+1-248-723-3330
Web site: http://www.cel-sci.com//
