US-based biotechnology firm CEL-SCI has received regulatory clearance from the Austrian Federal Office for Safety in Health Care to start patient enrolment in its Phase III head and neck cancer clinical trial of its investigational cancer immunotherapy treatment Multikine (Leukocyte Interleukin, Injection).
The approval makes Austria the 14th country to participate in CEL-SCI’s trial, which is being conducted worldwide.
The Phase III trial is evaluating the use of the company’s Multikine immunotherapy as a first line treatment for patients diagnosed with advanced primary head and neck cancer, prior to standard of care, which involves surgery, chemotherapy and radiation therapy.
If approved for use following completion of the clinical development programme 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 to combat tumours.
In 2012, there were more than 150,000 new patients diagnosed with head and neck cancer in Europe, according to the European Head and Neck Society’s (EHNS) Makes Sense Campaign.
The campaign goal is to raise awareness of head and neck cancer symptoms to drive earlier diagnosis, which is a key factor in survival.
According to the campaign, if patients are diagnosed in the early stages of the disease there is an 80%-90% survival rate, though 60% of people with head and neck cancer present with locally advanced disease at diagnosis, and 60% of those people diagnosed at an advanced stage die from the disease within five years.
CEL-SCI chief executive officer Geert Kersten said: "We recently were a Gold Sponsor of the European Congress on Head and Neck Oncology 2014 conference, which was also sponsored by the European Head and Neck Society.
"We are encouraged to see that the increasing number of head and neck oncologists, who already have experience with Multikine, are looking to enroll more of their patients in our study."
The company said that further expansion of its Phase III head and neck cancer trial is underway with a goal to have a total of 880 patients enrolled through about 100 clinical centres through by the end of 2015.
In this trial, more than 200 patients are already enrolled and are being treated with Multikine.