CEL-SCI Corporation (NYSE AMEX: CVM) announced today that it has successfully produced and filled its first lot of Multikine® in preparation for the upcoming pivotal Phase III trial targeting advanced primary head and neck cancer.
“Over the past few months, we have been highly focused on staffing and testing the facility in order to ensure that we have the equipment, resources and personnel to deliver Multikine to patients in the Phase III trial”
The drug was filled in CEL-SCI's state-of-the-art "Cold-Fill" manufacturing facility. The Company completed this test in order to ensure that it is able to produce significant quantities of Multikine to support the 880 patient clinical trial which is expected to commence prior to the end of the year. CEL-SCI's manufacturing facility, located outside of Baltimore, has been designed to fill biologics such as Multikine in true cold conditions (4 degrees Centigrade) which prevents/minimizes the loss of biological activity.
"Over the past few months, we have been highly focused on staffing and testing the facility in order to ensure that we have the equipment, resources and personnel to deliver Multikine to patients in the Phase III trial," said Geert Kersten, CEL-SCI's Chief Executive Officer. "We recognize that in a trial of this scale involving a biologic there are many precautions that we need to take, and we have made excellent progress in completing these tasks so we can begin the trial later this year. With a strong balance sheet, the new manufacturing facility, a global CRO in place and having Phase III partners Teva Pharmaceuticals and Orient Europharma, we are well positioned to take Multikine through this pivotal trial. We believe that Multikine represents a paradigm shift in the way cancer patients are treated."