CEL-SCI is in the final stages of validating its 73,000 square foot current Good Manufacturing Practices (cGMP) manufacturing facility built to produce Multikine® for Phase III trials and commercial sales. The facility, which CEL-SCI can also use for contract manufacturing, includes cold 4°C Aseptic Filling—an important production component for many biodefense and biologic products. CEL-SCI does not know of any other facility in the U.S. that is able to provide cold 4°C finish and fill services on a...
CEL-SCI to Conduct First Clinical Study of Investigational LEAPS-H1N1 Treatment for Hospitalized H1N1 Infected Patients
CEL-SCI to Conduct First Clinical Study of Investigational LEAPS-H1N1 Treatment for Hospitalized H1N1
Infected Patients at Johns Hopkins University School of Medicine
Fri Nov 06 09:45:00 2009
EST
VIENNA, Va., Nov 06, 2009 /PRNewswire via COMTEX News Network/ --
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(R) 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 http://www.cel-sci.com
Copyright (C) 2009 PR Newswire. All rights reserved
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