CEL-SCI completes validation of its GMP manufacturing facility

Jan 12 2010

CEL-SCI Corporation (NYSE CVM), a late-stage oncology company and a developer of vaccines and therapeutics for the prevention and treatment of infectious diseases, announced today it has completed the validation of all critical utilities and manufacturing equipment at its GMP manufacturing facility in Maryland. Completion of this validation effort represents a very important milestone as it allows CEL-SCI to move forward with its drug manufacturing plans for the investigational cancer drug Multikine® for the upcoming head and neck Phase III clinical trial. The manufacturing facility is now also ready to offer Contract Manufacturing services which could commence following the manufacture of Multikine.

"Reaching this validation milestone represents a major step forward for CEL-SCI, as it will allow the Company to produce the drug necessary for our pivotal global Phase III clinical trial," said Geert Kersten, CEO of CEL-SCI. "We believe that having our own facility gives us greater control over the Multikine manufacturing process and helps increase the probability of Multikine becoming an approved drug."

The Phase III clinical trial with Multikine will focus on advanced primary head and neck cancer patients. It will enroll approximately 800 patients in about 11 countries around the world and will evaluate Multikine's ability to increase the overall survival of treated patients when used in conjunction with the current standard of care treatment.

The clinical need is great as treatment prospects for these patients have not improved much over the past decades, the market is very large and since CEL-SCI has all of the major marketing rights, the potential is very significant. Head and neck cancer represents about 6% of all of the world's cancer.

In Phase II clinical trials Multikine was shown to be safe and well-tolerated, and to improve patients' overall survival by 33% over what can be attained with standard treatment alone (without the addition of Multikine therapy) at a median of three and a half years following surgery. The U.S. Food and Drug Administration (FDA) gave the go-ahead for this Phase III clinical trial and granted orphan drug status to Multikine in the neoadjuvant therapy of patients having squamous cell carcinoma (cancer) of the head and neck.