VIENNA, Va., Oct. 9 /PRNewswire-FirstCall/ -- CEL-SCI Corporation
(NYSE: CVM) announced today that it has taken delivery of the new
manufacturing facility for its lead drug Multikine(R). This dedicated
facility, located in the Baltimore area, 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 will soon be
commercial ready. As it stands today, the facility can produce about $600
million worth of drug per year. Within one year it can be built out to
product almost $2 billion worth of drug per year.
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. Our next step
is to completely validate the facility and to bring it on line for
manufacturing."
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.
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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