Daniel Zimmerman, inventor of the L.E.A.P.S.(TM) technology from which the herpes vaccine is derived, and Vice President of Research, Cellular Immunology, at CEL-SCI Corporation says, "We have shown protection against herpes simplex infectivity in animals. Our ultimate goal is to bring to market a preventive and therapeutic vaccine against herpes simplex infection in humans for which there is no approved vaccine or curative treatment available."
The vaccine is based upon CEL-SCI's patented L.E.A.P.S. (Ligand Epitope Antigen Presentation System) technology. It consists of two protein pieces (peptides). The first one is a copy of a portion of the herpes simplex virus against which the human immune system generates a response and the second one is a T-cell binding ligand, which stimulates and directs the immune response. The combination of these two peptides is called the herpes simplex L.E.A.P.S. vaccine.
In the past, some vaccines have worked simply by vaccination with viral proteins (e.g. hepatitis B) to immunize patients. In the case of herpes simplex, that strategy has yet to be proven successful. The purpose of adding the T-cell binding ligand was to increase the effectiveness of the vaccine by directing the immune response to react in the way most likely to eliminate or control the disease agent. To test this hypothesis in herpes simplex, the researchers not only administered the vaccine with a T-cell binding ligand to direct the immune response to the cellular side (thought to be protective), but they also administered a vaccine using a different T-cell binding ligand to direct the immune response to the humoral (antibody) side (thought to be non-protective). For both vaccines, the herpes simplex peptide was kept the same. RESULT: The vaccine inducing a cellular immune response was protective while the vaccine inducing a humoral (antibody) immune response was not protective and actually accelerated disease progression.
Herpes simplex virus type 1 and its close cousin, herpes simplex virus type 2, cause the common cold sore found near the lips and also genital herpes. Herpes simplex virus can also cause serious disease upon infection of the eye, the brain or an individual who is immunosuppressed such as a newborn baby, AIDS patient or transplant patient. Unlike many viruses, once an individual is infected with herpes simplex virus, the virus remains and can be reactivated by stress or immunosuppression and cause recurrent disease. There are an estimated 40 to 60 million Americans who are infected with herpes simplex virus and approximately 600,000 new cases occurring per year. A successful herpes simplex virus vaccine would prevent initial infection and may also be useful as a treatment for individuals who suffer from frequent recurrent disease.
CEL-SCI Corporation is a pioneer in the field of natural immunotherapy. The Company is developing immune based treatments for cancer, AIDS, tuberculosis, malaria and herpes simplex.
When used in this report, the words "intend," "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 clinic results demonstrated in preclinical 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 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, 1997. 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.
May 27, 1998