CEL-SCI Corporation (NYSE Amex: CVM), a developer of vaccines and therapeutics for the prevention and treatment of infectious diseases and a late-stage oncology company, announced today that the U.S. Food and Drug Administration (FDA) has indicated that the Company can proceed with its first clinical trial to evaluate the effect of its investigational LEAPS-H1N1 treatment on the white blood cells of hospitalized H1N1 patients. This followed the very responsive and expedited initial review of CEL-SCI's regulatory submission for this study proposal. Following completion of manufacturing, initiation of this first study is subject to IRB review and approval.
In order for FDA to fully consider a next-stage clinical trial to evaluate LEAPS-H1N1 treatment of hospitalized patients with laboratory-confirmed H1N1 Pandemic Flu under an Exploratory IND, FDA has asked CEL-SCI to submit a detailed follow-up regulatory filing with extensive additional data. Thus, in parallel with ramping up its first study, CEL-SCI is proceeding on an expedited basis with the substantial undertaking necessary to complete this next submission. Recognizing that it cannot proceed with its next-stage clinical trial without the Agency's concurrence, CEL-SCI anticipates engaging in a detailed dialogue with FDA regarding the proposed LEAPS-H1N1 clinical-development program based upon this future filing.
"CEL-SCI recognizes the importance of not only developing, but extensively testing an intervention that has the potential to treat Pandemic Flu," commented CEL-SCI CEO Geert Kersten. "We appreciate the expedited review by the FDA of our initial submission, particularly given how much time and attention the expert scientists at FDA are directing to Pandemic Flu amidst all the other demands placed on the Agency in the course of fulfilling its critical public health mission. Moving forward, we also appreciate FDA's willingness to consider CEL-SCI's LEAPS-H1N1 clinical development program in detail on as expedited a basis as possible in the context of the evolving public health concerns posed by Pandemic Flu. As we prepare to initiate our first study, CEL-SCI expects to work closely with FDA and experts in the field in developing the necessary data and appropriate protocols to ensure that we rigorously meet the FDA regulatory requirements. We are all collectively trying to help those H1N1-infected patients who are at high risk of dying."
The initiation of CEL-SCI's rapidly-accelerated LEAPS-H1N1 clinical development program builds on CEL-SCI's pioneering work with its L.E.A.P.S.(TM) technology in the context of H1N1. CEL-SCI's L.E.A.P.S. (Ligand Epitope Antigen Presentation System) technology allows the Company to direct an immune response against specific disease epitopes. In the case of CEL-SCI's investigational LEAPS-H1N1 treatment, this involves non-changing regions of H1N1 Pandemic Flu, Avian Flu (H5N1), and the Spanish Flu. This is intended to enable stimulation of the specifically-needed immune responses, while avoiding the administration of regions of H1N1, and other viruses, which may exacerbate the problem of cytokine storm, which CEL-SCI scientists believe may be involved in the death of some H1N1 patients.
L.E.A.P.S. technology is a novel T-cell modulation platform technology that enables CEL-SCI to design and synthesize, non-recombinantly, proprietary immunogens. The L.E.A.P.S. technology combines a small peptide that activates the immune system with a small peptide from a disease-related protein, such as the H1N1 hemagglutinin molecule, to make an investigational product that induces defined immune responses. Each L.E.A.P.S. construct is composed of a T cell binding ligand (TCBL) which previously has demonstrated the ability to induce and elicit protective immunity and antigen-specific antibody production in animal models. Thus, extensive animal studies conducted to date indicate that 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.