CEL-SCI Presents Data for CEL-1000 as a Vaccine Adjuvant with Recombinant Hepatitis B Virus Protein

Thursday, September 20, 2007 General News
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VIENNA, Va., Sept. 19 CEL-SCI Corporation(Amex: CVM) announces that its CEL-1000 immunomodulator was shown to be ableto jump start the immune response against the recombinant hepatitis B virusprotein more quickly than did other vaccine adjuvants. This effect in themouse model was seen within 14 days, most pronounced with a single dose ofCEL-1000 at day 0 and resulted in up to a 40% increase in antibody signal atday 28. Also, the timing of the CEL-1000 administration had significantimpact on the type of immune response that was created, as well as itsstrength.

The significance of this data lies in the fact that CEL-1000 appears to beable to mount a faster immune response, something that is absolutely necessaryfor a bio defense or a pandemic flu setting, as well as the potential abilityto create more effective immune responses through the use of CEL-1000 as anadjuvant. The data were presented by Dr. Daniel H. Zimmerman, Senior VicePresident of Research, Cellular Immunology at CEL-SCI and involved acollaboration with scientists at several other institutions including Drs.Kenneth S. Rosenthal Professor of Microbiology and Immunology at NortheasternOhio Universities Colleges of Medicine and Pharmacy (NEOUCOM), Rootstown,Ohio, Frank Klotz of Biocon, Rockville, Maryland, Peter Blackburn and SteveGrimes of Mercia-Pharma, New York. The data were presented at the 47rdInterscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) inChicago, Illinois.

Dr. Zimmerman said, "These findings are important not just for our CEL-1000 adjuvant, but also for any adjuvant because our work has shown that thetiming of the use of the adjuvant and how often it is given have significantinfluence on the type and strength of the immune responses elicited."

In challenge studies, CEL-1000 has also previously been shown to protectanimals against infection against viruses and unrelated diseases, specificallyherpes simplex virus, viral encephalitis and malaria.

CEL-1000 appears to activate innate (very early stage) and Th1 type(cellular) immune responses to induce a broad-spectrum protection againstinfection in animal models. The innate immune system is generally accepted tobe the first line of defense against infectious agents.

CEL-1000, derived from the beta chain of human MHC-II, is a modifiedversion of a human immune-based protein known to bind to both human and mouseimmune cells and appears to act by enhancing the host's protective immuneresponse.

About CEL-SCI Corporation:

CEL-SCI Corporation is developing products that empower immune defenses.Its lead product is Multikine(R). In Phase II clinical trials Multikine wasshown to be safe and well-tolerated, and to improve the patients' overallsurvival by 33% at a median of three and a half years following surgery. TheU.S. Food and Drug Administration (FDA) gave the go-ahead for a Phase IIIclinical trial with Multikine in January 2007 and granted orphan drug statusto Multikine in the neoadjuvant therapy of squamous cell carcinoma (cancer) ofthe head and neck in May 2007.

Multikine, a patented defined mixture of naturally derived cytokines, isthe first immunotherapeutic agent in a new class of drugs called "ImmuneSIMULATORS". Immune SIMULATORS simulate the way our natural immune systemacts in defending us against cancer. As opposed to other immunotherapieswhich are designed to target a single or limited number of specific antigensor molecules, Immune SIMULATORS are multi-targeted; they simultaneously causea direct and targeted killing of the specific tumor cells and they activatethe immune system to produce a stronger anti-tumor attack on multiple fronts.

Multikine is also the first immunotherapeutic agent being developed as afirst-line standard of care treatment for cancer. It is administered prior toany other cancer therapy because that is the period when

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