VIENNA, Va., March 3 /PRNewswire-FirstCall/ -- CEL-SCI CORPORATION (Amex: CVM) provided details today at its 2008 Annual Meeting of Shareholders on groundbreaking activities currently underway at its manufacturing facility near Baltimore, Maryland. The facility will be used to manufacture Multikine(R), the Company's lead compound, for a pivotal Phase III clinical trial as first-line therapy of previously untreated head and neck cancer patients. The facility, which is being built by the design builder BE&K (http://www.bek.com/index.asp), is expected to be completed during the third quarter of 2008, with manufacturing and patient enrollment to begin soon thereafter.
"I am excited to announce to our shareholders the excellent progress we have made in constructing our manufacturing facility in the short period of time since we have broken ground," said Geert Kersten, CEL-SCI's Chief Executive Officer. "We believe the facility will provide us with tight control over the manufacturing process, eliminating a key risk of the pivotal trial. Multikine represents a completely novel medicine with blockbuster potential to treat a large unmet medical need and we are eager to begin this open label trial."
Mr. Kersten continued, "We are starting to receive more recognition for our work. The February 2008 issue of MedAdNews, a highly respected and authoritative publication serving the pharmaceutical industry, ran its 8th annual report on FUTURE BLOCKBUSTERS stating that 'These medicines are expected to eventually garner FDA approval and break the annual billion-dollar sales barrier'. Our Multikine was one of the 10 medicines named."
The article can be accessed on CEL-SCI's website at http://www.cel-sci.com under recent media coverage.
At the Annual Shareholder's Meeting, the Company's executives also
provided highlights from fiscal year 2007. Some of the highlights include:
-- FDA clearance of Multikine for Phase III clinical trial in head and
-- Raised U.S. $15 million
-- Multikine granted Orphan drug designation in U.S.
-- Started build-out of manufacturing facility for Multikine to support
upcoming Phase III study and future commercial sale
-- Started planning and pricing of global clinical trial designed to lead
to marketing approval for Multikine
All matters submitted to a vote of the shareholders were approved by a vote of the shareholders at the Annual Meeting.
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|
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