VIENNA, Va., Sept. 16 /PRNewswire-FirstCall/ -- CEL-SCI Corporation
(Amex: CVM) announced today that it expects to take delivery of the new
manufacturing facility for its lead drug Multikine(R) on October 8, 2008.
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. The facility, which cost about $22
million to build, is state of the art and commercial ready.
Geert Kersten, CEL-SCI's Chief Executive Officer said, "Multikine
started with the idea that activating the immune system to fight cancer
could be beneficial and successful, as long as you could activate the
immune system before it was weakened by surgery, radiation and
chemotherapy. Our clinical studies showed significant benefit to the cancer
patients treated with Multikine. We are now in the home stretch. Having our
own Multikine dedicated manufacturing facility gives us control and
eliminates a great deal of risk from our product development."
CEL-SCI is developing Multikine for approval as a first line indication
in head and neck cancer. To that end, the Company's upcoming Phase III
clinical trial is an 800 patient clinical study designed to demonstrate
that administration of its cancer drug Multikine to head and neck cancer
patients before they receive any 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 worldwide.
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. This facility is expected to be
completed on October 8, 2008.
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.
CEL-SCI 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. Most recently CEL-SCI
announced that its newly discovered rheumatoid arthritis vaccine showed
excellent results in animal tests.
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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