VIENNA, Va., June 9 CEL-SCI Corporation(Amex: CVM) and researchers at Northeastern Ohio Universities Colleges ofMedicine and Pharmacy jointly announced favorable new developments in theLEAPS(TM) heteroconjugate vaccine technology developed by CEL-SCI at the FOCISImmunology meeting in Boston, MA on June 8, 2008. Patricia Taylor, M.S.,working with Dr. Ken S. Rosenthal, Professor of Microbiology and Immunology atthe Northeastern Ohio Universities Colleges of Medicine and Pharmacy and Dr.Dan Zimmerman, CEL-SCI's Senior Vice President of Research and CellularImmunology, demonstrated that immunization with a LEAPS (Ligand EpitopeAntigen Presentation System) vaccine altered the immunological hormone(cytokine) balance toward a Th1 environment. It has been shown that a Th1cellular immune response is needed for protection against many viral diseases.Th1 promotes a combination of antibody and cell mediated protective immuneresponses compared to the antibody producing Th2 environment induced by mostvaccines.
Most notably, within three days of immunization with the "J" type LEAPSvaccines, the cytokine that drives a Th1 response, IL-12, and the primarycytokine that mediates its effects, interferon gamma, were detected in theblood. The LEAPS vaccines that were examined include one that was previouslyshown to provide antigen specific protection and cellular immunity againstherpes simplex virus infection via interferon gamma in mouse models of humandisease and another that is directed against a HIV protein.
Dr. Zimmermann said: "These findings give us a new way to stimulate theimmune system to fight viral diseases. They also may lead to new treatmentsagainst autoimmune diseases by redirecting established immune responses,stopping their attack upon the body."
The LEAPS vaccine consists of a portion of an HSV or HIV protein attachedto a portion of another very small protein (immune cell binding ligand (ICBL))chosen to promote and direct the immune response to the virus. By themselves,neither the ICBL nor the viral peptides initiate protection but whenconjugated together, the LEAPS vaccines promote immune responses that canprotect against HSV-1.
Vaccination against HSV and HIV has the potential to prevent initialinfection; prevent or lessen the severity of disease; and prevent spread ofthe virus to sexual partners as well as to neonates and newborns. The LEAPSvaccines is one of several approaches to the development of safe and effectivevaccines are being pursued.
About CEL-SCI Corporation:
CEL-SCI Corporation is developing products that empower immune defenses.Its lead product is Multikine(R). In Phase II clinical trials Multikine wasshown to be safe and well-tolerated, and to improve the patients' overallsurvival by 33% at a median of three and a half years following surgery. TheU.S. Food and Drug Administration (FDA) gave clearance for a Phase IIIclinical trial with Multikine in January 2007 and granted orphan drug statusto Multikine in the neoadjuvant therapy of squamous cell carcinoma (cancer) ofthe head and neck in May 2007.
Multikine, a patented defined mixture of naturally derived cytokines, isthe first immunotherapeutic agent in a new class of drugs called "ImmuneSIMULATORS". Immune SIMULATORS simulate the way our natural immune systemacts in defending us against cancer. As opposed to other immunotherapieswhich are designed to target a single or limited number of specific antigensor molecules, Immune SIMULATORS are multi-targeted; they simultaneously causea direct and targeted killing of the specific tumor cells and they activatethe immune system to produce a stronger anti-tumor attack on multiple fronts.
Multikine is also the first immunotherapeutic agent being developed as afirst-line standard of care treatment for cancer. It is administered prior toany other cancer therapy because that is the period w