CEL-SCI Corporation (NYSE CVM), a developer of vaccines and therapeutics for the prevention and treatment of infectious diseases and a late-stage oncology company, announced today the start of the Company's first clinical study for hospitalized H1N1 patients at The Johns Hopkins University School of Medicine (Johns Hopkins). The study is being led by Principal Investigator Jonathan M. Zenilman, MD, Professor of Medicine, Johns Hopkins School of Medicine and Chief of Infectious Diseases Division, Johns Hopkins Bayview Medical Center. This initial study will involve taking blood from 20 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 parallel, the study will involve taking blood from 20 healthy individuals not infected with H1N1 and activating their cells with the LEAPS-H1N1 investigational therapy to serve as a control for the patient group in the study.
In September, the Company announced that the FDA had indicated that the Company could commence this study. 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.
"We are pleased that we have been able to move so fast with this first study of our LEAPS-H1N1 treatment," said Geert Kersten, CEL-SCI's Chief Executive Officer. "As we move forward, we hope that our investigational immunotherapy can be shown to modulate patients' immune responses to be effective without the cytokine storm that CEL-SCI's scientists believe may be responsible for so many deaths."
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.
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