VIENNA, Va., Sept. 5 /PRNewswire-FirstCall/ -- CEL-SCI Corporation (Amex: CVM) announced today that it presented new rheumatoid arthritis data at the Marcus Evans conference on Immunogenicity in Amsterdam. The data, presented by Dr. Daniel Zimmerman, Senior Vice President of Research, Cellular Immunology of CEL-SCI, indicate that CEL-SCI's rheumatoid arthritis vaccine CEL-2000 prevents or retards the permanent tissue damage caused by rheumatoid arthritis in an animal model of the disease. These new findings further support previous positive results announced for this vaccine in June 2008. The data were derived from a histopathological analysis of tissues samples collected in comparative studies of CEL-2000 and Enbrel(R) that were conducted in a well established animal model of rheumatoid arthritis. Enbrel is a leading treatment for people with rheumatoid arthritis.
In the studies, the mice were injected with collagen on days 0 and 21 to induce the disease. Once the mice reached a significant and uniform disease state, therapy with Enbrel or CEL-2000 was initiated and continued for 28 days. CEL-2000 was administered only twice and Enbrel was administered either every day for the first 14 days (for the histopathology and immunology studies) or every other day over the entire study period of 28 days (for the immunology studies only).
Dr. Zimmerman reported previously that in studies conducted in mice treated similarly, CEL-2000 was equivalent or possibly superior to Enbrel in slowing disease progression and lessening symptoms. The new data presented today indicate that, in mice vaccinated with CEL-2000 after appearance of visible disease, statistically significant less inflammation and permanent damage with regard to 1) bone erosion, 2) cartilage destruction, and 3) pannus formation were observed. These are some of the same parameters that can be seen in rheumatoid arthritis damage in humans. CEL-2000 was as good as, and possibly superior to, Enbrel in slowing further disease progression as evaluated by these histological parameters and by footpad swelling as well as externally visible joint damage.
"It is very exciting to see the reduction of severe rheumatoid arthritis damage in these animals through a simple vaccination," said Dr. Zimmerman. "I hope that CEL-2000 will some day be used to lessen the damage caused by rheumatoid arthritis in patients."
CEL-2000 may offer a number of potential advantages over the existing rheumatoid arthritis treatments. Data collected in the animal studies conducted with CEL-2000 demonstrate it is effective with fewer and smaller doses. It is also potentially less toxic and more disease specific therapy. Finally, CEL-2000 could also be useful for patients who are not able to take or who may be unresponsive to existing products.
Rheumatoid arthritis treatments comprise a $13 billion market. Enbrel, a leading rheumatoid arthritis treatment sold by Amgen and Wyeth, reported US sales in 2007 of about $3.2 billion. Enbrel is a soluble recombinant protein of a human TNF-alpha receptor linked to human IgG Fc. In some cases, human or humanized monoclonal antibodies to TNF-alpha have also been used for therapy in rheumatoid arthritis. These therapies remove or inactivate TNF-alpha, a natural human cytokine required in many immune functions for normal defenses.
CEL-SCI's rheumatoid arthritis vaccine CEL-2000 was discovered as part of work with the Company's ongoing research and development activities with its L.E.A.P.S.(TM) (Ligand Epitope Antigen Presentation System) technology. L.E.A.P.S.(TM) is a novel T-cell modulation platform technology that enables CEL-SCI to design and synthesize proprietary immunogens. Any disease for which an antigenic sequence has been identified, such as infectious, parasitic, malignant or autoimmune diseases and allergies, are potential therapeutic or preventive sites for the application of L.E.A.P.S.(TM) technology.
The concept behind the L.E.A.P.S.(TM) technology is to directly mimic cell/cell interactions on the T-cell surface with synthetic peptides. The L.E.A.P.S.(TM) constructs containing the antigenic disease epitope linked to a T-cell binding ligand (TCBL) can be manufactured by peptide synthesis or by covalently linking the two peptides. Depending upon the type of L.E.A.P.S.(TM) construct and TCBL used, CEL-SCI is able to direct the outcome of the immune response towards the development of T-cell function with primarily effector T-cell functions (T Lymphocyte; helper/effector T lymphocyte, type 1 or 2 [Th1 or Th2], cytotoxic [Tc] or suppressor [Ts]). Therefore, it would appear that the L.E.A.P.S.(TM) construct represents a chimeric peptide with bi-functional behavior.
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.
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.
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 for the year ended September 30, 2007. 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.
|SOURCE CEL-SCI Corporation|
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