Northwest Biotherapeutics, a U.S.-based biotech company, has received approval in Switzerland for commercial use of the world’s first vaccine against brain cancer. Northwest Biotherapeutics is also working to win approval in the U.S. and the rest of Europe. In clinical trials, patients treated with DCVax-Brain survived twice as long as those who didn’t receive the vaccine, without major side effects, the company said. The product will be produced in the U.S., and made available to patients at treatment
centers in Switzerland.
The DCVax products are personalized treatments, made by combining a patient’s own master immune cells (dendritic cells) with cancer biomarkers derived from or displayed by the patient’s own tumor. Precursors of the master immune cells are continuously circulating in a patient’s blood and are obtained through a blood draw. The master immune cells are then matured and activated through a series of proprietary steps, then “educated” by exposure to the patient’s tumor biomarkers, and injected back into the patient through a simple intradermal injection in the arm or thigh, consisting of just a few drops. Studies showed that the medicine delays recurrence of the tumor by 18.1 months for new patients.
While making DCVax-Brain commercially available to patients at selected medical centers in Switzerland, Northwest Biotherapeutics is also conducting a Phase II trial in 141 patients in the U.S. The trial began enrolling patients in December 2006 and is anticipated to conclude by the end of 2008. The company plans to seek product approval in both the U.S. and EU in early 2009, based upon the results of the Phase II pivotal trial.
Dr. Alton Boynton, President and CEO of Northwest Biotherapeutics, pointed out that Switzerland is an attractive place to begin commercialization, “due to its highly respected regulatory oversight, and its growing experience with cellular therapies. Switzerland is also increasingly noted for medical tourism, and is easily accessible for many medical tourists.” According to Dr. Boynton, his company plans to bring DCVax-Brain to patients in additional countries, and to apply the DCVax technology to many other cancers, including five for which they have already have FDA clearance to begin clinical trials.
According to the U.S. National Cancer Institute, there are 19,000 new cases of primary brain cancer diagnosed each year. The five-year survival rate is around 30%. Brain cancers can strike all ages, and are the leading cause of cancer deaths in children under the age of 20.