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CEL-SCI's H1N1 Clinical Study News Seen as Credibility Booster
Friday, November 06, 2009 2:39 PM


BioMedReports.Com, is reporting that one of several expected key news developments has been announced by CEL-SCI Corporation (NYSE Amex: CVM), today. An Institutional Review Board of The Johns Hopkins University School of Medicine (Johns Hopkins) has given clearance for the Company's first clinical study involving the much talked about L.E.A.P.S.™ H1N1 investigational therapy.

Johns Hopkins will host the study, which will be 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. As previously announced, this initial 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.

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.™ technology in the context of H1N1. As previously discussed in this space by Dr. Daniel Zimmerman, inventor of the L.E.A.P.S.™ technology, the technology allows the Company to direct an immune response against specific disease epitopes. The technology's reach will go beyond the H1N1 space, into fields of treatment like rheumatoid arthritis since those responses can be designed to be directed at a great number of human diseases.

In the case of CEL-SCI's investigational LEAPS-H1N1 treatment, this involves non-changing regions of the H1N1 Pandemic Flu as well as the Avian Flu (H5N1), and the Spanish Flu.

"We are pleased that such a prestigious medical center has given clearance to proceed with this first study of our LEAPS-H1N1 treatment," said Geert Kersten, CEL-SCI's Chief Executive Officer. "Given the nature and severity of the virus, we are working diligently with our CRO and Johns Hopkins, and actively preparing submissions to the FDA, to support the fastest and most effective way to conduct clinical trials going forward for this unique investigational treatment."

In September, the company announced that the FDA had indicated that they could commence this study and scientists at the company have been working hard on various aspects of what is expected to be the first of several upcoming expedited steps to get this treatment authorized and out to those hospitalized patients who desperately need it.




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