Mr. Kersten continued, "If the huge success of Dendreon's Provenge?® has defined the first generation of cancer immunotherapy, we expect our Multikine to define the second generation. Multikine is an off the shelf product making large commercial production possible, it contains both passive and active immunity and is given before any other cancer therapy, a time when cancer immunotherapy should be most successful."
In Phase II clinical trials Multikine was shown to be safe and well-tolerated, and to eliminate the tumor in 12% of the patients after only three weeks of treatment. This patient response preceded the commencement of the current treatment regimen which includes one or a combination of surgery, radiation and chemotherapy. Follow-up showed an improvement in the Multikine treated patients' overall survival by 33% at a median of three and a half years following surgery. The U.S. Food and Drug Administration (FDA) gave the go-ahead for a 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.
SOURCE CEL-SCI Corporation