Results expected to Support Licensing Activities
VIENNA, Va., Jan. 7 /PRNewswire-FirstCall/ -- CEL-SCI Corporation (NYSE Alternext US: CVM) announced today the initiation of a definitive study of its new rheumatoid arthritis treatment vaccine (CEL-2000) to determine the long-lasting beneficial effects on animals with the disease. The study is being conducted at the request of a large pharmaceutical company which is evaluating the possibility of acquiring a global license for the vaccine from CEL-SCI. The long-term results, previously presented at the 6th annual GTCbio Vaccine conference, for the CEL-2000 vaccine were better than or comparable to those for Enbrel(R), a leading treatment for people with rheumatoid arthritis.
"We are very excited to see a prominent pharmaceutical company express interest in licensing the vaccine," said Geert Kersten, CEL-SCI's Chief Executive Officer. "As a result of the very good data with this novel approach, we believe that the prospects for licensing the vaccine are promising."
The definitive experiment will confirm the efficacy and durability of the response to the vaccine and will further assess the safety of the CEL-2000 vaccine, in preparation for possible human trials. CEL-2000 may also offer a number of other potential advantages over existing rheumatoid arthritis treatments, such as Enbrel. The data from animal studies of rheumatoid arthritis using CEL-2000 treatment vaccine demonstrated that CEL-2000 is an effective treatment against arthritis with fewer administrations than those required by other anti-rheumatoid arthritis treatments, including Enbrel(R). CEL-2000 is also potentially a more disease type specific therapy is calculated to be significantly less expensive and may be useful in patients unable to tolerate or who may not be responsive 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 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.
SOURCE CEL-SCI Corporation