CEL-SCI Announces Discovery of Novel Compound for the Treatment of Rheumatoid Arthritis

VIENNA, Va., June 17 /PRNewswire-FirstCall/ -- CEL-SCI Corporation today announced the discovery of a novel peptide for the treatment of rheumatoid arthritis. This peptide, called CEL-2000, was tested in a well established animal model of rheumatoid arthritis and was compared to Enbrel(R), a leading treatment for people with rheumatoid arthritis. The tests showed that CEL-2000 is equivalent or possibly superior to Enbrel in slowing disease progression and lessening symptoms in mice. In addition, the vaccine has the potential to require fewer and smaller doses, be less toxic, more disease specific and much less invasive. The Company also believes that the drug could be attractive to patients who are not able to take or be responsive to Enbrel, Remicade(R) or Humira(R).

Rheumatoid arthritis treatments comprise a $13 billion market. Enbrel, a leading rheumatoid arthritis treatment, reported US sales in 2007 of about $3.2 billion. 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.

Dr. Daniel Zimmerman, Senior Vice President of Research, Cellular Immunology of CEL-SCI said, "Rheumatoid arthritis is a disease in which the immune system mistakenly attacks the joints and causes a chronic inflammation of the joints, leading to a sequel that can result in severe joint deformation, often with multiple joints involved, and progressive debilitation. We believe that our CEL-2000 vaccine works by reprogramming the faulty immune responses that attack the patient's joints to reduce or stop those attacks."

Dr. Zimmerman continued, "The treatment of rheumatoid arthritis has undergone many significant improvements in the last 10 years. We hope to add to those improvements by bringing to market this very easy to administer and completely novel way of treating patients. Many patients could benefit from having such a treatment added to their current therapy or given in place of the current therapy to avoid toxicities." Dr. Zimmerman presented these new data today at the SMi 4th Biannual Vaccine Conference in London.

To induce the disease, mice were injected with collagen on days 0 and 21. Once the mice reached a significant and uniform disease state, therapy with Enbrel and CEL-2000 was initiated. CEL-2000 was administered only twice and Enbrel was administered every other day over the entire study period of 28 days.

The mice were scored at least 3 times a week for arthritis index, foot pad swelling and weekly weight change. Periodically, sera were collected for assessment of parameters relating to immune status. No significant weight changes were observed.

Mice administered two doses of CEL-2000, given on either day 0 and 7 or day 0 and 14, showed a statistically significant decrease in disease progression and were less symptomatic than the mice given Enbrel every other day until day 28. Expected serological changes were observed for both anti-L.E.A.P.S.(TM) vaccines and collagen in these groups.

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 RA. These therapies remove or inactivate TNF-alpha, a natural human cytokine required in many immune functions for normal defenses.

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.

About CEL-SCI:

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.

CONTACT: Gavin de Windt of CEL-SCI Corporation, +1-703-506-9460

Web site: http://www.cel-sci.com/

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