Cel-SCI - Cel-1000 wirksames Präparat für H5N1-Patienten (Vogelgrippe) - 500 Beiträge pro Seite

[SLC2005]

CEL-SCI CORP
WKN: 871 006
ISIN: US1508374097
Ticker-Symbol CVM (AMEX)

http://www.cel-sci.com/

CEL-SCI CORPORATION RELEASES BIRD (AVIAN) FLU LETTER TO SHAREHOLDERS


VIENNA, VA, APRIL 3, 2006 -- The following letter is being released by CEL-SCI CORPORATION (AMEX: CVM) 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 FILES PATENT FOR PREVENTION/TREATMENT OF

BIRD (AVIAN) FLU




VIENNA, VA, APRIL 4, 2006 -- CEL-SCI CORPORATION (AMEX: CVM) announces that it has filed a provisional U.S. patent application covering its drug CEL-1000 for the prevention/treatment of bird flu and/or as an adjuvant to be included in a bird flu vaccine.



Geert Kersten, Chief Executive Officer of CEL-SCI said, “By filing this patent in the U.S., we are preserving our rights to file patents on this invention world-wide.”



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 provides antigen-independent (i.e., non-disease specific) and broad-spectrum protection upon challenge with the disease causing agent(s), which is important against the bird flu virus since it exhibits a high mutation rate.



CEL-1000, is a patented defined amino acid sequence derived from the beta chain of human MHC-II, which itself 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. It 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).



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," “plans,” "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. 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.

[volkerg]

Gestern +111% an der AMEX... aber da ist noch mehr drin: ist die Phase III - Zulassung der FDA in trockenen Tüchern, dann ist der gestrige Anstieg nur ein Startschuss gewesen!

[SLC2005]

AP
Cel-Sci Up on Bird Flu Claim, Patent
Tuesday April 4, 12:44 pm ET
Cel-Sci Shares Jump After Bird Flu Vaccine Enhancer Assertion, Patent Filing


VIENNA, Va. (AP) -- Shares of Cel-Sci Corp. jumped Tuesday after the tiny biotech said its vaccine enhancement candidate could serve as a stopgap measure to protect people during the period it takes for a bird flu vaccine to take effect.
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Cel-Sci rose 18 cents, or nearly 22 percent, to $1 in afternoon trading on the American Stock Exchange. Over the past 52 weeks, shares have traded in a range of 44 cents to $1.06, and have more than doubled in value since the start of the year.

The company cited a study in the New England Journal of Medicine that showed it took about five to six weeks for a test vaccine made by French drug maker Sanofi Aventis AS to produce an immune response. Cel-Sci said its CEL-1000 enhancer works at an early stage of the immune response and protects against a number of virus and diseases in animal tests.

Additionally, the company feels CEL-1000 can increase the study's reported 54 percent response rate, and place less strain on stockpiles by allowing for a lower dose of vaccine.

Separately, Cel-Sci said it filed a provisional patent for CEL-1000 to be used as a vaccine enhancer in the prevention and treatment of bird flu.

[SLC2005]

bizjournals.com
Cel-Sci flies on Avian flu vaccine
Tuesday April 4, 1:36 pm ET


Stock in Northern Virginia biotechnology company Cel-Sci rallied as much as 21 percent Tuesday, after the company filed a patent application for an Avian flu vaccine.
The Vienna-based company says the application covers its drug CEL-1000 for both the prevention and treatment of bird flu.


The drug provides broad-spectrum protection, which Cel-Sci says is important against the bird flu virus because the virus exhibits a high mutation rate.

In December, Cel-Sci signed an agreement with the National Institutes of Health to test the vaccine as a potential Avian flu vaccine in clinical trials with animals. The drug has shown positive results in animal tests against herpes simplex virus, encephalitis and malaria.

Cel-Sci (AMEX: CVM - News) is one of several area biotechs developing an Avian flu vaccine. Gaithersburg-based MedImmune (NASDAQ: MEDI - News) is also working with NIH to produce and test vaccines against potential pandemic flu strains.

Novavax (NASDAQ: NVAX - News) is advancing clinical trials of its experimental bird flu vaccine. The company is now based in Philadelphia, but maintains a research facility in Rockville.

Cel-Sci shares rose 18 cents to $1 per share in Tuesday trading. Its stock has doubled since the beginning of the year.

Published April 4, 2006 by the Washington Business Journal