CEL-SCI Expands Testing of Its Vaccine to Determine Efficacy Against H1N1 Influenza

The use of L.E.A.P.S. vaccine technology for immunization in animal models has already been shown to provide protection from viral diseases without causing an immune response associated with the deadly "cytokine-storm" seen in many of the victims of influenza.

Dr. Daniel Zimmerman, inventor of the L.E.A.P.S. technology, and currently a consultant to CEL-SCI, said, "Various L.E.A.P.S. technology constructs have already been shown to induce protection in animal challenge models against a variety of diseases such as malaria and herpes simplex virus and as therapeutic vaccines in two different autoimmune conditions. Data showed that L.E.A.P.S. vaccines were able to induce these protective immune responses without the excessive induction of pro-inflammatory cytokines. This is thought to be very important in the swine flu, or the avian flu, since it appears that the excessive production of pro-inflammatory cytokines during the course of the disease is responsible for and may lead to the increased number of deaths from these illnesses."

Recently, collaborators at the University of Hawaii reported on data at the annual American Society for Microbiology in Philadelphia, PA. This data demonstrates that vaccines utilizing its L.E.A.P.S. vaccine technology with specificity for particular Mycobacterium tuberculosis (TB) antigens can elicit immune responses that would be protective against tuberculosis and have the potential to treat swine and other H1N1 influenzas. The investigators presented data that showed that blood and spleen cells from immunized mice produced gamma interferon in response to the vaccine, while the cells from mice in the various control groups did not.

The L.E.A.P.S. technology 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. Each L.E.A.P.S. construct is composed of a T cell binding ligand (TCBL) which has previously demonstrated the ability to induce and elicit protective immunity and antigen specific antibody production in animal models.

The concept behind the L.E.A.P.S. technology is to directly mimic cell/cell interactions on the dendritic and T-cell surface with synthetic peptides. The L.E.A.P.S. constructs containing the antigenic disease epitope linked to an Immune/T-cell binding ligand (I/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 I/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]). The L.E.A.P.S. vaccine constructs are chimeric peptides which combine antigen specificity with immune response modulation.

CEL-SCI Corporation is developing products that empower immune defenses. Its lead product is Multikine(R) which is currently being readied for a global Phase III trial. The Company has operations in Vienna, Virginia, and Baltimore, Maryland.

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