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CEL-1000 Peptide Shows Adjuvant Activity with Malaria Vaccines Wednesday April 19, 9:35 am ET
VIENNA, Va., April 19 /PRNewswire-FirstCall/ -- CEL-SCI CORPORATION (Amex: CVM - News) announced today that its CEL-1000 peptide showed adjuvant activity when used with a peptide based malaria vaccine and a DNA based malaria vaccine in animal challenge studies as part of a Cooperative Research arrangement with the Naval Medical Research Center, Silver Spring, MD. In both cases the one time addition of the patent protected CEL-1000 to the vaccines resulted in significant increases in the protection of the animals.
This new data indicates that CEL-1000 has protective activity in various animal models. These results are very important because CEL-SCI is planning to develop CEL-1000 as a potential addition to the different bird flu vaccines currently under development by the pharmaceutical and biopharmaceutical industry. It recently became very apparent that there is a great need for an adjuvant for these vaccines. Adjuvants are designed to improve the effectiveness of vaccines.
On March 30, 2006 the New England Journal of Medicine ("NEJM") published the results of the first human testing of a H5N1 bird (avian) 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 identified 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.
Dr. Daniel Zimmerman, Senior V.P of Research, Cellular Immunity, at CEL- SCI Corporation said, "This new data confirms our belief that CEL-1000 could be an important addition to the bird flu vaccines. That is why CEL-SCI is in contact with all of the major bird flu vaccine developers to test CEL-1000 with their vaccines."
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.
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. Upon challenge with the disease causing agent(s), CEL- 1000 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.
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.
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CEL-SCI Extends Agreement With U.S. Navy for CEL-1000 Drug Thursday April 20, 9:30 am ET
VIENNA, Va., April 20 /PRNewswire-FirstCall/ -- CEL-SCI CORPORATION (Amex: CVM - News) announces that it has extended its Cooperative Research and Development Agreement (CRADA) with the Naval Medical Research Center (NMRC) of the U.S. Navy to jointly evaluate CEL-SCI's patented drug CEL-1000 against several species of malaria causing Plasmodium and as an adjuvant with various malaria vaccines. This extension is the result of recently completed and ongoing studies with CEL-1000 at the NMRC.
CEL-1000 is a patented small peptide that has induced protective responses against malaria, herpes simplex, viral encephalitis and cancer upon challenge in animals. The peptide is a modified version of a human sequence known to bind to both human and mouse immune cells and as such, the results obtained are thought to have direct applicability in man.
CEL-1000 is currently being tested by the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institute of Health, for the prevention/treatment of the avian flu virus in animal models. CEL-1000 has also been proposed as a very promising agent for enhancing the activity of avian flu vaccines, thereby "stretching" the avian flu vaccine supply.
It has been previously reported that CEL-1000 peptide induced immune responses which afforded 100% protection against malaria (P. yoelii) infection in the mouse model after the administration of only two doses of CEL-1000 (5 microgram) at 2 to 4 weeks prior to challenge. Even when administered as a single dose or at a dose as low as 1 microgram, significant protection was observed.
Protection was defined as a total lack of malaria parasites in the blood of the animals at several time points for up to two weeks following challenge, a very stringent test. The peptide appears to increase the animal's ability to fight off challenges via the immune system arm responsible for interferon gamma.
Malaria affects about 300-500 million people per year and is responsible for about 2.7 million deaths annually. It is a parasitic disease that is transmitted by mosquitoes. The emergence of drug resistant strains is a major problem as is the emergence of insecticide resistant strains of mosquitoes. Another problem is the need for a low cost preventive or treatment against malaria since most of the world's cases are located in the developing world. The U.S. Navy has a particular interest in malaria to protect military personnel and in the humanitarian goal of reducing malaria mortality in areas of the world that carry the risk of malaria infection.
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. The Company's lead product Multikine® is cleared to enter Phase III clinical trials with advanced primary head and neck cancer patients.
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.
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Cel-Sci, Navy Extend Drug Study Thursday April 20, 11:35 am ET Cel-Sci, U.S. Navy to Extend Co-Evaluation of Malaria Drug
VIENNA, Va. (AP) -- Cel-Sci Corp. said Thursday it extended its partnership with the Naval Medical Research Center to jointly evaluate malaria drug CEL-1000. The drug is still in preclinical trials, but the company said it shows promise to improve the effectiveness of vaccines for malaria and other diseases, including avian flu.
The World Health Organization said malaria affects about 350-500 million people a year and is responsible for about a million deaths annually. Most infections and deaths occur in sub-Saharan Africa.
Shares of Cel-Sci, which have traded between 44 cents and $1.78 over the last year, rose 4 cents, or 3 percent, to $1.35 in morning trading on the American Stock Exchange.
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