CEL-SCI Corporation (NYSE AMEX: CVM), a developer of vaccines and therapeutics for the treatment of infectious diseases and a late-stage oncology company, announced today that it has hired a full-service Clinical Research Organization (CRO) with an office in the Washington, D.C./Baltimore area to support its conduct of the upcoming clinical trial of its investigational LEAPS-H1N1 treatment. Last week, CEL-SCI announced that the U.S. Food and Drug Administration (FDA) had 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 by the FDA. Following completion of manufacturing, initiation of this first study is subject to IRB review and approval. The study will involve taking blood from hospitalized, laboratory-confirmed H1N1 patients and activating their cells with the LEAPS-H1N1 investigational therapy in order to assess the cells' response as the basis for the planned future treatment of this patient population under a next-stage clinical trial protocol.
In order for FDA to fully consider that 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.
"Recognizing that this virus was first identified only five months ago, we are moving as fast as possible to investigate the potential of LEAPS-H1N1 to help H1N1-infected patients who are at high risk of dying. 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," commented CEL-SCI CEO Geert Kersten.
The initiation of CEL-SCI's rapidly-accelerated LEAPS-H1N1 clinical development program builds on CEL-SCI's pioneering work with its LEAPS technology in the context of H1N1. CEL-SCI's L.E.A.P.S.(TM) (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.