US firm CEL-SCI Corp provided details 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 (interleukins), 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 is expected to be completed during the third quarter of 2008, with manufacturing and patient enrollment to begin soon thereafter.
Geert Kersten, the firm's chief executive, said: "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 [Food and drug Administration] approval and break the annual billion-dollar sales barrier.' Our Multikine was one of the 10 medicines named."
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