In Phase II clinical trials Multikine was shown to be safe and well-tolerated, and to eliminate the tumors in 12% of the patients after only three weeks of treatment. Follow-up showed an improvement in the survival rate of those patients treated with Multikine of 33% at a median of three and a half years following surgery. Results of the trial also showed that the treatment regimen killed, on average, about half of the cancer cells before the start of standard therapy like surgery, radiation and chemotherapy. The U.S. Food and Drug Administration gave the go-ahead for a Phase III clinical trial and granted orphan drug status to Multikine in the neoadjuvant therapy of patients with squamous cell carcinoma of the head and neck.

CEL-SCI is also engaged in multiple other activities related to the start its Phase III clinical trial in 9 countries around the world. The trial is expected to be the largest head and neck cancer clinical study ever conducted, and is the first Phase III study in the world in which immunotherapy is given to patients first, prior to receiving any treatment for cancer, including surgery, radiation and/or chemotherapy. This should be the optimal time to stimulate an immune response against the tumor as the immune system has not yet been weakened by the conventional cancer therapies.

Source CEL-SCI Corporation