CEL-SCI Presents Data For CEL-1000 As A Vaccine Adjuvant With Recombinant Hepatitis B Virus Protein

Main Category: Liver Disease / Hepatitis
Also Included In: Immune System / Vaccines
Article Date: 20 Sep 2007 - 0:00 PDT

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CEL-SCI Corporation (Amex: CVM) announces that its CEL-1000 immunomodulator was shown to be able to jump start the immune response against the recombinant hepatitis B virus protein more quickly than did other vaccine adjuvants. This effect in the mouse model was seen within 14 days, most pronounced with a single dose of CEL-1000 at day 0 and resulted in up to a 40% increase in antibody signal at day 28. Also, the timing of the CEL-1000 administration had significant impact on the type of immune response that was created, as well as its strength.

The significance of this data lies in the fact that CEL-1000 appears to be able to mount a faster immune response, something that is absolutely necessary for a bio defense or a pandemic flu setting, as well as the potential ability to create more effective immune responses through the use of CEL-1000 as an adjuvant. The data were presented by Dr. Daniel H. Zimmerman, Senior Vice President of Research, Cellular Immunology at CEL-SCI and involved a collaboration with scientists at several other institutions including Drs. Kenneth S. Rosenthal Professor of Microbiology and Immunology at Northeastern Ohio Universities Colleges of Medicine and Pharmacy (NEOUCOM), Rootstown, Ohio, Frank Klotz of Biocon, Rockville, Maryland, Peter Blackburn and Steve Grimes of Mercia-Pharma, New York. The data were presented at the 47rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Chicago, 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 the timing of the use of the adjuvant and how often it is given have significant influence on the type and strength of the immune responses elicited."

In challenge studies, CEL-1000 has also previously been shown to protect animals against infection against viruses and unrelated diseases, specifically herpes 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 against infection in animal models. The innate immune system is generally accepted to be the first line of defense against infectious agents.

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.

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 was shown to be safe and well-tolerated, and to improve the patients' overall survival by 33% at a median of three and a half years following surgery. The U.S. Food and Drug Administration (FDA) gave the go-ahead for a Phase III clinical trial with Multikine in January 2007 and granted orphan drug status to Multikine in the neoadjuvant therapy of squamous cell carcinoma (cancer) of the head and neck in May 2007.

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

Multikine is also the first immunotherapeutic agent being developed as a first-line standard of care treatment for cancer. It is administered prior to any other cancer therapy because that is the period when the anti-tumor immune response can still be fully activated. Once the patient has advanced disease, or had surgery or has received radiation and/or chemotherapy, the immune system is severely weakened and is less able to mount an effective anti-tumor immune response. Other immunotherapies are administered after the patient has received chemotherapy and/or radiation therapy, which can limit their effectiveness.

The Company has operations in Vienna, Virginia and Baltimore, Maryland. CEL-SCI's other products, which are currently in pre-clinical stage, have shown protection against a number of diseases in animal tests and are being tested against diseases associated with bio-defense and avian flu.

CEL-SCI Corporation
http://www.cel-sci.com