VIENNA, Va., Oct. 7 /PRNewswire-FirstCall/ -- CEL-SCI Corporation
(NYSE: CVM) announced today that it has entered into a Material Transfer
Agreement (MTA) with the National Institutes of Health Clinical Center
(NIHCC) and the laboratory of Dr. Francesco M. Marincola, M.D., to
investigate the molecular basis of changes to the tumor microenvironment
caused by CEL-SCI's cancer drug Multikine. Dr. Marincola is the Chief of
the Infectious Disease and Immunogentics Section, Department of Transfusion
Medicine Clinical Center, National Institutes of Health, a leading national
and international medical research laboratory.
Pursuant to the agreement, CEL-SCI will provide tumor samples of
Multikine treated and untreated matched control patients to the NIHCC,
which will then use the latest molecular genomic microarray technology
developed by Dr. Marincola's laboratory to look for molecular genomic
differences in the tumor microenvironment in patients with squamous cell
carcinoma of the head and neck. Should these pre-clinical experiments find
significant differences between the Multikine treated and untreated
patients, a formal collaboration between CEL-SCI and the NIHCC may be
developed in order to expand the study to include patients from CEL-SCI's
Pivotal global Phase III clinical trial.
"Multikine's potential to change the tumor microenvironment and, in
doing so, break tumor tolerance has been a long-time goal of anti-cancer
immunotherapy. We are very excited to be working with Dr. Marincola and the
NIH Clinical Center to determine the molecular basis of Multikine's ability
to cause tumor microenvironment changes," said Dr. Talor, Senior VP of
Research and Manufacturing at CEL-SCI and the developer of Multikine.
About CEL-SCI's Phase III Cancer Drug Multikine:
CEL-SCI is developing Multikine for approval as a first-line indication
in head and neck cancer. The company's upcoming Pivotal global Phase III
clinical trial is an 800 patient study designed to demonstrate that
administration of its anti-cancer drug Multikine to head and neck cancer
patients before they receive their first conventional cancer treatment will
increase their survival. Head and neck cancer is one of the world's biggest
cancers affecting about 650,000 people per annum.
In Phase II clinical trials Multikine was shown to be safe and
well-tolerated, and to improve the 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 with
Multikine in January 2007 and granted orphan drug status to Multikine for
the neoadjuvant therapy of squamous cell carcinoma (cancer) of the head and
neck, in May 2007. In the summer of 2007 CEL-SCI started construction of
the manufacturing facility to produce Multikine for the global Phase III
trial and subsequent sale following approval. This facility is expected to
be completed soon.
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.
The Company has operations in Vienna, Virginia and Baltimore, Maryland.
CEL-SCI's other products, which are currently in pre-clinical stage, have
shown protection against a number of diseases in animal tests and are being
tested against diseases associated with bio-defense.
NO ENDORSEMENT OF ANY ORGANIZATION, PRODUCT OR SERVICE MENTIONED IN
THIS ARTICLE IS INTENDED OR INFERRED BY THE NATIONAL INSTITUTES OF HEALTH
OR ITS EMPLOYEES.
SOURCE CEL-SCI Corporation
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Related links:
http://www.cel-sci.com//
CONTACT:
Gavin de Windt of CEL-SCI Corporation,
+1-703-506-9460
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