VIENNA, Va., Oct. 19 /PRNewswire-FirstCall/ -- CEL-SCI Corporation (NYSE Amex: CVM) announced today the presentation of new rheumatoid arthritis data at the American College of Rheumatology's annual meeting in Philadelphia, PA. The data, presented by Dr. Daniel Zimmerman in conjunction with the Company's collaborators from Washington Biotech, Northeastern Ohio Universities College of Medicine and BolderBiopath, indicate that CEL-SCI's rheumatoid arthritis treatment vaccine CEL-2000 acts to prevent or retard the permanent tissue damage caused by rheumatoid arthritis in animals. These statistically significant results were demonstrated by the measurement of four different parameters, suggesting that CEL-2000 appears to block the immune response that causes the autoimmunity which leads to rheumatoid arthritis. The long term results obtained with fewer doses of CEL-2000 vaccine were comparable or better than those seen with Enbrel®, a leading treatment for people with rheumatoid arthritis.
Geert Kersten, Chief Executive Officer of CEL-SCI said, "These results were achieved through a reduction of the inflammatory response that attacks the patient's joints. The goal for our new H1N1 therapy for H1N1 hospitalized patients is not dissimilar. Many of these patients die from the excessive inflammatory response. We feel that this new data is encouraging both for this rheumatoid arthritis vaccine as well as supportive of our H1N1 treatment."
In these studies, mice were injected with collagen to induce the autoimmune disease. Therapy with Enbrel or CEL-2000 was initiated and continued for 28 days after the initiation of a significant, uniform, and measurable level of arthritic disease in groups of mice. CEL-2000 was administered only twice, but Enbrel was administered every other day for the first 28 days. The extent of disease, as indicated by deformation of foot joints (Arthritic Index (AI) score), of untreated, and CEL-2000 and Enbrel treated groups, was compared. In another study CEL-2000 was administered 5 times over a 70 day period and the animals were monitored for another 20 days for a total study period of 90 days. In each case, CEL-2000 treatment proved effective at blocking the progression of disease with statistically significant reduction in AI score compared to the appropriate controls and was safe and well tolerated without any adverse effects. The protection mediated by CEL-2000 treatment was also demonstrated histologically by significant reductions in 1) inflammation, 2) cartilage destruction 3) bone resorption, and 4) pannus membrane formation in the synovial space compared to untreated controls.
The CEL-2000 treatment appeared to change the course of the immune response in the diseased and treated animals by limiting the development of a destructive Th17 and tumor necrosis factor alpha (TNF-alpha) directed autoimmune response. Analysis of serum levels of 21 cytokines/chemokines indicated reductions in the characteristic cytokine markers of rheumatoid arthritis, TNF-alpha and IL-17, and also IL-6, and MCP-1. A number of cytokine changes were also seen with Enbrel treatment, but to a lesser degree.
CEL-2000 may also offer a number of potential advantages over existing rheumatoid arthritis treatments, such as Enbrel. Data collected in the animal studies conducted with CEL-2000 demonstrated that CEL-2000 is an effective treatment against arthritis even with the administration of fewer treatments. CEL-2000 is also potentially a more disease-type specific therapy, should be significantly less expensive and finally, CEL-2000 could also be useful for patients who are not able to take or who may be unresponsive to existing anti-arthritis therapies.
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 specific against 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. 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. technology.
The concept behind the L.E.A.P.S. technology is to directly mimic cell-cell interactions and activate immune cells with synthetic peptides. The L.E.A.P.S. constructs containing the antigenic disease epitope linked to a immune-cell binding ligand (ICBL) can be manufactured by peptide synthesis or by covalently linking the two peptides. Depending upon the type of L.E.A.P.S. construct and ICBL 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. construct represents a chimeric peptide with bi-functional behavior.
Additional details on the presentation are available at http://acr.confex.com/acr/2009/webprogram/Paper10996.html.
CEL-SCI Corporation is developing products that empower immune defenses. Its lead product is Multikine® which is being readied for a global Phase III trial in advanced primary head and neck cancer. CEL-SCI is also developing a treatment for hospitalized H1N1 patients using its L.E.A.P.S. technology platform and expects to soon finish the validation of its state-of-the-art facility in Maryland.
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, lack of regulatory clearance to proceed with clinical trials, an inability to duplicate the clinical results demonstrated in clinical studies that have been completed or that are initiated in the future, timely development of any potential products that can be shown to be safe and effective, unwillingness of regulatory authorities to engage in further regulatory dialogue, 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, 2008. 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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