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CEL-SCI Corporation Releases Letter to Shareholders
VIENNA, Va., January 28 /PRNewswire-FirstCall/ -- The following letter is being released by CEL-SCI CORPORATION (Amex: CVM) to its shareholders:
January 28, 2008
Dear Fellow Shareholders:
Our Company underwent a wonderful transformation last year from an intermediate stage company in its development to a late-stage biotechnology company. We are now one of a very select number of companies that have a completely novel medicine with blockbuster potential ready to go into a Phase III clinical trial. Our position is further enhanced by the fact that we are well capitalized and that we are building our own manufacturing facility close to Baltimore, Maryland. This facility will be capable of producing between $500 million and $600 million worth of Multikine® cancer drug per year, with the ability to triple production within about one year. The construction of the facility is scheduled for completion in the 3rd quarter of 2008.
Company highlights of 2007:
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FDA clearance of Multikine for Phase III clinical trial in head and neck cancer |
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Raised U.S. $15 million |
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Multikine granted Orphan drug designation in U.S. |
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Started build-out of manufacturing facility for Multikine to support upcoming Phase III study and commercial sale |
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Started planning and pricing of our global clinical trial designed to lead to marketing approval for Multikine |
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We expect 2008 to be another very positive year. We plan to contract with one or more Clinical Research Organizations to run our 800 patient Multikine Phase III trial which we expect to start in the last quarter of 2008. It will be run as an open label study (a study in which it is apparent which patients receive Multikine versus those who do not). The open label design will give us the opportunity to get early indications of how successful our study will be.
We look forward to moving into the new facility later this year and we anxiously await the first indications from the open-label Phase III clinical trial with Multikine in advanced primary (not yet treated) head and neck cancer, representing a large unmet medical need and a disease in dire need of new and non-toxic treatments.
Thank you for your support.
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Sincerely, |
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Geert Kersten
Chief Executive Officer |
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Maximilian de Clara
President and Chairman of the Board |
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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, 2006. 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.
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