CEL-SCI Corporation announced the Ministry of Health Malaysia has cleared the company to commence patient enrollment for its phase III head and neck cancer trial of its investigational cancer immunotherapy treatment Multikine (leukocyte interleukin, injection) in Malaysia. Malaysia is the 20th country to approve CEL-SCI's phase III trial, which now has over 350 patients enrolled.

"Our plan called for having the trial cleared and conducted in a total of 21 countries, the United States plus 20 other countries. We are almost there," stated CEL-SCI chief executive officer Geert Kersten.

The Multikine phase III study is enrolling patients with advanced primary, not yet treated, head and neck cancer. The objective of the study is to demonstrate 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.

Multikine (leukocyte interleukin, injection) is an investigational immunotherapeutic agent that is being tested in an open-label, randomised, controlled, global pivotal phase III clinical trial as a potential first-line treatment for advanced primary (not yet treated) head and neck cancer. If approved for use following completion of CEL-SCI's clinical development program for head and neck cancer, 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. CEL-SCI is aiming to complete enrollment of subjects to the phase III head and neck cancer study by the end of 2015.

In October 2013, CEL-SCI announced that it had signed a CRADA (Cooperative Research and Development Agreement) with the US Naval Medical Center, San Diego, to develop Multikine as a potential treatment for HIV/HPV co-infected men and women with peri-anal warts. The Phase I trial started enrolling patients in September 2014. CEL-SCI also entered into two new co-development agreements with Ergomed to further clinically develop Multikine for cervical dysplasia/neoplasia in HIV/HPV co-infected women and for peri-anal warts in HIV/HPV co-infected men and women.

CEL-SCI's work is focussed on finding the best way to activate the immune system to fight cancer and infectious diseases. CEL-SCI believes that the best way may be to activate the immune system of patients before they have received surgery, radiation and/or chemotherapy. Its lead investigational therapy Multikine is currently being studied in a pivotal phase III clinical trial against head and neck cancer. If the study endpoint, which is a 10 per cent improvement in overall survival of the subjects treated with Multikine treatment regimen as compared to subjects treated with current standard of care only is satisfied, the study results will be used to support applications which will be submitted to regulatory agencies in order to receive from these agencies commercial marketing approvals for Multikine in major markets around the world. Additional clinical indications for Multikine which are being investigated include cervical dysplasia in HIV/HPV co-infected women, and the treatment of peri-anal warts in HIV/HPV co-infected men and women. A phase I trial of the former indication has been completed at the University of Maryland. The latter indication is now in a phase I trial in conjunction with the US Navy under a CRADA.

CEL-SCI is also developing its LEAPS technology for the treatment of pandemic influenza and as a potential therapeutic vaccine against rheumatoid arthritis. CEL-SCI received a phase I SBIR Grant from the National Institutes of Health to develop LEAPS as a potential treatment for rheumatoid arthritis with researchers from Rush University Medical Center in Chicago, Illinois. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.

Multikine is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with our future anticipated regulatory submission for approval. Multikine has not been licenced or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data involving the investigational therapy Multikine. Further research is required, and early-phase clinical trial results must be confirmed in the well-controlled, phase III clinical trial of this investigational therapy that is currently in progress.