VIENNA, Va.–(BUSINESS WIRE)–
CEL-SCI Corporation (NYSE MKT:CVM) today announced that the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted regulatory approval to begin the Company’s Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection) in the United Kingdom (UK). The UK becomes the 13th country to join the trial. Several hospitals and medical clinics in the UK are expected to participate in the Phase III trial for the treatment of head and neck cancer.
“Patients and doctors alike are increasingly aware of the potential promise of immunotherapy in the fight against cancer. Approximately 200 patients are already enrolled in this Phase III study with Multikine and our goal is to have a total of 880 patients enrolled worldwide by the end of 2015,” stated CEL-SCI Chief Executive Officer Geert Kersten.
Further expansion of the trial is underway with a goal to have a total of about 100 clinical centers through 20 countries by the end of 2015.
About Multikine Phase III Study
The Multikine Phase III study (the IT-MATTERS 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 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.
About Multikine
Multikine (Leukocyte Interleukin, Injection) is an immunotherapeutic agent that is being tested in a randomized, controlled, global pivotal Phase III clinical trial as a potential first-line treatment for advanced primary head and neck cancer. If approved for use by the US FDA or other Regulatory agencies 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. The trial is expected to expand into a total of approximately 100 clinical centers in about 20 countries.
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. CEL-SCI also announced that it 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.
