CEL-SCI Retains Global Contract Research Organization to Manage Upcoming Phase III Clinical Trial for Its Cancer Drug Multikine
01 Décembre 2009 - 4:15PM
PR Newswire (US)
VIENNA, Va., Dec. 1 /PRNewswire-FirstCall/ -- CEL-SCI Corporation
(NYSE Amex: CVM), a late-stage oncology company and a developer of
vaccines and therapeutics for the prevention and treatment of
infectious diseases, announced today that it has retained the
services of an international Contract Research Organization (CRO)
to run CEL-SCI's upcoming Phase III clinical trial in advanced
primary head and neck cancer with the Company's lead product
candidate, Multikine®. This CRO is considered to be one of the
world's top CRO's for running global oncology studies. The
impending Phase III trial is expected to enroll up to 800 patients
with advanced primary head and neck cancer in multiple countries
around the world. It will evaluate Multikine's ability to increase
the overall survival of treated patients when used in conjunction
with the current standard of care treatment. "We are very pleased
to have retained the services of a well respected and
internationally recognized CRO which specializes in conducting
late-stage oncology trials to guide our pivotal Phase III trial for
Multikine," said Geert Kersten, Chief Executive Officer of CEL-SCI.
"After carefully evaluating many competing organizations, we have
chosen this CRO based on their extensive experience in managing
global clinical trials of medicines ultimately approved for the
treatment of cancer." In Phase II clinical trials Multikine was
shown to be safe and well-tolerated, and to improve patients'
overall survival by 33% at a median of three and a half years
following surgery. The U.S. Food and Drug Administration (FDA) gave
the go-ahead for a Phase III clinical trial and granted orphan drug
status to Multikine in the neoadjuvant therapy of squamous cell
carcinoma (cancer) of the head and neck. CEL-SCI recently took
delivery of its new state of the art manufacturing facility which
will produce Multikine for the upcoming Phase III trial. About
Multikine Multikine, a patented defined mixture of naturally
derived cytokines, is the first immunotherapeutic agent in a new
class of drugs called "Immune SIMULATORS". Immune SIMULATORS
simulate the way our natural immune system acts in defending us
against cancer. As opposed to other immunotherapies which are
designed to target a single or limited number of specific antigens
or molecules, Immune SIMULATORS are multi-targeted; they
simultaneously cause a direct and targeted killing of the specific
tumor cells and they activate the immune system to produce a
stronger anti-tumor attack on multiple fronts. Multikine is also
the first immunotherapeutic agent being developed as a first-line
standard of care treatment for cancer. It is administered prior to
any other cancer therapy because that is the period when the
anti-tumor immune response can still be fully activated. Once the
patient has advanced disease, or had surgery or has received
radiation and/or chemotherapy, the immune system is severely
weakened and is less able to mount an effective anti-tumor immune
response. Other immunotherapies are administered after the patient
has received chemotherapy and/or radiation therapy, which can limit
their effectiveness. 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 a vaccine to treat H1N1 hospitalized patients using its
L.E.A.P.S.(TM) technology platform. This investigational treatment
involves non-changing regions of H1N1 Pandemic Flu, Avian Flu
(H5N1), and the Spanish Flu as CEL-SCI scientists are very
concerned about the creation of a new more virulent hybrid virus
through the combination of H1N1 and Avian Flu, or maybe Spanish
Flu. The Company has operations in Vienna, Virginia, and Baltimore,
Maryland. For more information, please visit
http://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,
an inability to duplicate the clinical results demonstrated in
clinical studies, timely development of any potential products that
can be shown to be safe and effective, 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. DATASOURCE: CEL-SCI
Corporation CONTACT: Gavin de Windt of CEL-SCI Corporation,
+1-703-506-9460 Web Site: http://www.cel-sci.com/
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