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. (www.biorealty.com) and the design builder is BE&K, Inc. (www.bek.com/index.asp). Pictures of the manufacturing facility, located close to Baltimore, MD, can be accessed on CEL-SCI's website at 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.
SOURCE CEL-SCI CORPORATION