CEL-SCI to Conduct First Clinical Study of Investigational LEAPS-H1N1
Treatment for Hospitalized H1N1 Infected Patients at Johns Hopkins University
School of Medicine
VIENNA, Va., Nov. 6 /PRNewswire/ -- 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 an
Institutional Review Board of The Johns Hopkins University School of Medicine
(Johns Hopkins) has given clearance for the Company's first clinical study to
proceed. As a result, 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.
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 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."
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.
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.
About CEL-SCI Corporation
CEL-SCI Corporation is developing products that empower immune defenses. Its
lead product is Multikine® which is being readied for a global Phase III trial
in advanced primary head and neck cancer. CEL-SCI is also developing an
immunotherapy to prevent and treat swine and other influenzas using its
L.E.A.P.S. technology platform and expects to soon finish the validation of
its state-of-the-art facility in Maryland which it expects to utilize to
launch aseptic filling for stem cell produced therapies and other biological
products. The Company has operations in Vienna, Virginia, and Baltimore,
Maryland.
For more information, please visit www.cel-sci.com.
When used in this report, the words "intends," "believes," "anticipated" and
"expects" and similar expressions are intended to identify forward-looking
statements. Such statements are subject to risks and uncertainties which could
cause actual results to differ materially from those projected. Factors that
could cause or contribute to such differences include, lack of regulatory
clearance to proceed with clinical trials, an inability to duplicate the
clinical results demonstrated in clinical studies that have been completed or
that are initiated in the future, timely development of any potential products
that can be shown to be safe and effective, unwillingness of regulatory
authorities to engage in further regulatory dialogue, receiving necessary
regulatory approvals, difficulties in manufacturing any of the Company's
potential products, inability to raise the necessary capital, and the risk
factors set forth from time to time in CEL-SCI Corporation's SEC filings,
including but not limited to its report on Form 10- K/A for the year ended
September 30, 2008. The Company undertakes no obligation to publicly release
the result of any revision to these forward-looking statements which may be
made to reflect the events or circumstances after the date hereof or to
reflect the occurrence of unanticipated events.
SOURCE CEL-SCI Corporation
Gavin de Windt of CEL-SCI Corporation, +1-703-506-9460
