The manufacturing facility is now ready to offer contract manufacturing services which could commence following the manufacture of Multikine.
Reportedly, the phase III clinical trial with Multikine will focus on advanced primary head and neck cancer patients. It is expected to enroll approximately 800 patients in about 11 countries. It will evaluate Multikine’s ability to increase the overall survival of treated patients, when used in conjunction with the current standard of care treatment.
Furthermore, in the trial, 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.
FDA has approved the phase III trial and granted orphan drug status to Multikine in the neoadjuvant therapy of patients having squamous cell carcinoma (cancer) of the head and neck.
Geert Kersten, CEO of CEL-SCI, said: “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. 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.”