New manufacturing site drives trials of Multikine drug

CEL-SCI Corporation has taken delivery of a new manufacturing facility in Baltimore, US that will support the development an immunotherapeutic agent used to treat cancer.

The Multikine drug will be produced in a facility estimated to cost $22m to build. The drug will be developed as a first-line standard of care treatment for cancer. It will also be 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.

As it stands, the facility can produce about $600m worth of drug per year. Within one year, it can be built out to product almost $2bn worth of drug per year. Construction started in 2007.

CEL-SCI's ceo Geert Kersten, 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."

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.

The US Food and Drug Administration (FDA) gave the go-ahead for a Phase III clinical trial with Multikine in January 2007 and granted orphan drug status to Multikine in the neoadjuvant therapy of squamous cell carcinoma (cancer) of the head and neck in May 2007. It is administered prior to any other cancer therapy because that is the period when the anti-tumor immune response can still be fully activated. Once the patient has advanced disease, or had surgery or has received radiation and/or chemotherapy, the immune system is severely weakened and is less able to mount an effective anti-tumor immune response. Other immunotherapies are administered after the patient has received chemotherapy and/or radiation therapy, which can limit their effectiveness.