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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