CEL-SCI Corporation it has taken delivery of its new manufacturing facility for its lead drug Multikine(R). This dedicated facility, located in the Baltimore area, 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. The facility, which cost about $22 million to build, is state of the art and will soon be commercial ready. As it stands today, the facility can produce about $600 million worth of drug per year. Within one year it can be built out to product almost $2 billion worth of drug per year. Geert Kersten, CEL-SCI’s Chief Executive Officer said, “Multikine started with the idea that activating the immune system to fight cancer could be beneficial and successful, as long as you could activate the immune system before it was weakened by surgery, radiation and chemotherapy. Our clinical studies showed significant benefit to the cancer patients treated with Multikine. We are now in the home stretch. Having our own Multikine dedicated manufacturing facility gives us control and eliminates a great deal of risk from our product development. Our next step is to completely validate the facility and to bring it on line for manufacturing.” CEL-SCI is developing Multikine for approval as a first line indication in head and neck cancer. To that end, the company’s upcoming Phase III clinical trial is an 800 patient clinical study designed to demonstrate that administration of its cancer drug Multikine to head and neck cancer patients before they receive any conventional cancer treatment will increase their survival. Head and neck cancer is one of the world’s biggest cancers affecting about 650,000 people per annum worldwide.
