Switzerland Authorizes World's First Therapeutic Vaccine for Brain Cancer for Commercial Patient Use

According to a prnewswire.com press release by Northwest Biotherapeutics, Inc., the Swiss Institute of Public Health has authorized the use of DCVax-Brain for treatment of brain caner patients in Switzerland. DCVax-Brain is the first commercially available vaccine of its kind. The vaccine will be available to patients in the third quarter of 2007.

Northwest Biotherapeutics feel that Switzerland's regulatory oversight, experience with cellular therapies, and increased medical tourism make Switzerland an ideal place to begin their vaccine availability. Northwest Biotherapeutics plans on expanding the vaccine to additional countries. The company also wishes to use the technology in the DCVax-Brain vaccine to help develop vaccines for other cancers as well. Currently the company is at the Phase III pivotal trial state for prostate cancer. The company has also received FDA clearance for clinical trials in 5 other cancers.

Northwest Biotherapeutics began enrolling patients in the U.S. for a Phase II pivotal trial. The trial has enrolled 141 U.S. patients, beginning in December 2006. The company also plans to file for product approval in the U.S. and E.U. in 2009 based on the Phase II pivotal trial. Currently the DCVax-Brain has been given orphan drug status in the U.S. and E.U. The orphan drug status will give the DCVax-Brain vaccine 7 years of exclusivity in the U.S. market and 10 years of exclusivity in the E.U. market. The exclusivity privilege is based on whether it will be the first product of this type to reach approval.

The press release notes that brain cancers affects persons of all ages, and are the leading cause of cancer deaths in the under age 20 group. Brain cancers currently have limited treatment, are very lethal, and have a median survival rate of 14.6 months. Northwest Biotherapeutics reveals that in clinical trials newly diagnosed, and recurrent, brain cancer patients treated with the vaccine doubled their survival time. Trials results also concluded that the vaccine delays disease recurrence from 6.9 months to 18.1 months for patients that are newly diagnosed.