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CEL-SCI secures approval in Romania to start Phase III Multikine trial

US-based CEL-SCI has received clearance from the Romanian Ministry of Health to start patient enrollment in its Phase III trial of its investigational cancer immunotherapy treatment Multikine (Leukocyte Interleukin, Injection) to treat advanced primary head and neck cancer.

The open-label, randomized, controlled, global pivotal trial is enrolling patients with advanced primary, not yet treated, head and neck cancer.

The trial’s main objective is to show a statistically significant improvement in the overall survival of enrolled patients who are treated with the Multikine treatment regimen plus Standard of Care (SOC) vs. subjects who are treated with SOC only.

If approved, Multikine would be a different type of therapy in the fight against cancer, one that appears to have the potential to work with the body’s natural immune system in the fight against tumors.

By the end of 2015, the company intends to complete patient enrollment in this trial, which is expected to expand into a total of 100 clinical centers in about 20 countries in addition to the US.

In October 2013, the company signed a cooperative research and development agreement (CRADA) with the US Naval Medical Center, San Diego, to develop Multikine to treat HIV/HPV co-infected men and women with peri-anal warts.

The company also entered into two new co-development agreements with Ergomed to further clinically develop Multikine for cervical dysplasia/neoplasia in women who are co-infected with HIV and HPV and for peri-anal warts in men and women who are co-infected with HIV and HPV.