VIENNA, Va., June 4 /PRNewswire-FirstCall/ -- In response to numerous
shareholder questions, CEL-SCI CORPORATION (Amex: CVM) is providing an
update on the construction of its manufacturing facility near Baltimore,
Maryland. The facility, when fully built out, will comprise 73,000 square
feet and will be used to manufacture Multikine(R), the Company's lead
cancer product. This dedicated facility will produce the Multikine that
will be used for CEL-SCI's pivotal Phase III clinical trial for first-line
therapy of previously untreated head and neck cancer patients, and
subsequently for sale following approval of the drug.
Upon completion of the first phase of the build out (28,000 square
feet) in the 2008 third quarter, the facility will be capable of supporting
approximately $600 million of annual commercial sales of Multikine. The
facility build out is currently about 70% complete. The facility is being
developed for CEL-SCI by BioRealty, Inc. (http://www.biorealty.com) and the design
builder is BE&K, Inc. (http://www.bek.com/index.asp). Pictures of the
manufacturing facility, located close to Baltimore, MD, can be accessed on
CEL-SCI's website at http://www.cel-sci.com under "Special Highlights", "Pictures
of Manufacturing Facility".
"CEL-SCI has been advised by BE&K that the manufacturing facility is on
target to be completed on schedule," said Geert Kersten, CEL-SCI's Chief
Executive Officer. "The facility will provide CEL-SCI with tight control
over the Multikine manufacturing process, eliminating key risks to the
successful completion of the pivotal Phase III trial and ultimately the
licensing of Multikine for sale. Recent issues faced by Genzyme with its
approval for Myozyme for Pompe's disease highlight again the need to run
the pivotal Phase III clinical trial with drug that is manufactured in the
same facility as the one the company will use for drug for sale."
About CEL-SCI's Phase III Cancer Drug Multikine:
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 in
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 Phase III trial and
subsequent sale following approval.
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.
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 for the year ended
September 30, 2007. 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.
Available Topic Expert(s): For information on the listed expert(s), click
appropriate link.
Gavin de Windt
https://profnet.prnewswire.com/Subscriber/ExpertProfile.aspx?ei=58059
SOURCE CEL-SCI CORPORATION
 back to top
Related links:
http://www.cel-sci.com
http://www.biorealty.com http://www.bek.com/index.asp
CONTACT:
Gavin de Windt of CEL-SCI Corporation,
+1-703-506-9460
|
