New Data Points to Long Lasting Beneficial Effects of CEL-SCI's Rheumatoid Arthritis Vaccine
VIENNA, Va., November 14, 2008 /PRNewswire-FirstCall/ -- CEL-SCI Corporation announced today the presentation of new rheumatoid arthritis data at the 6th annual GTCbio Vaccine Conference in Vienna, Va. The data, presented by Dr. Daniel Zimmerman, Senior Vice President of Research, Cellular Immunology of CEL-SCI, indicate that CEL-SCI's rheumatoid arthritis treatment vaccine CEL-2000 prevents or retards the permanent tissue damage caused by rheumatoid arthritis. The long term results obtained with CEL-2000 vaccine, for the rheumatoid arthritis, were in line with those seen with Enbrel(R), a leading treatment for people with rheumatoid arthritis.
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.
In these studies, mice were injected with collagen on days 0 and 21 to induce the disease. Once the mice cohorts reached a significant and uniform and measurable disease (arthritis) state, therapy with Enbrel or CEL-2000 was initiated and continued for 28 days. CEL-2000 was administered only twice and Enbrel was administered every other day for the first 28 days and an arthritic Index score was determined for both groups. The observation period was doubled from previous studies and was continued for another 28 days for a total study period of 56 days.
"It is very exciting to see the reduction of severe rheumatoid arthritis damage in these animals through a simple vaccination," said Dr. Zimmerman. "I am hopeful that CEL-2000 will one day be used to lessen the damage caused by rheumatoid arthritis in patients."
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 on the T-cell surface with synthetic peptides. The L.E.A.P.S. 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. 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. 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) which is being readied for a global Phase III trial. 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.
CONTACT: Gavin de Windt of CEL-SCI Corporation, +1-703-506-9460
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Posted: November 2008