Northwest Biotherapeutics, a US-based biotechnology company which has just listed on the AIM London exchange, says that it has won approval in Switzerland for the world’s first therapeutic vaccine for brain cancer.
The company noted that it has been given the go-ahead by the Swiss Institute of Public Health to make DCVax-Brain available for treatment of brain cancer patients in Switzerland and marketing will start in the third quarter. Clinical trial data to date have shown that DCVax-Brain delays disease recurrence from 6.9 to 18.1 months for newly diagnosed patients and extends survival from 14.6 months to more than 33 months. Also the therapy does not cause the debilitating side effects associated with treatments such as chemotherapy.
DCVax-Brain is currently in a Phase II trial in the USA, involving 141 patients, which should conclude around the end of 2008. Approvals will be sought in both the USA and the European Union in early 2009, Northwest said, noting that the vaccine has been granted orphan drug status in both regions,
DCVax products are personalised treatments, made by combining a patient’s own master immune, or dendritic, cells with cancer biomarkers derived from the patient’s own tumour. The master immune cells are then matured and activated, then “educated” by exposure to the patient’s tumour biomarkers, and put back into the patient through an intradermal injection in the arm or thigh, consisting of just a few drops.
Northwest also added that unlike many personalised treatments, DCVax products will be cost-effective because a single manufacturing run can produce at least three years of personalised treatments for a particular patient, that are then stored frozen. The firm claims that this system helps it keep costs “at a level that can enable product pricing in a range comparable to other cancer drugs”.
Benefit of Switzerland’s medical tourism
Chief executive Alton Boynton said that Switzerland is an attractive place to begin commercialisation, not least because the country “is also increasingly noted for medical tourism, and is easily accessible for many medical tourists”. He added that the firm is applying its DCVax technology to many other cancers and is already at the Phase III stage in prostate cancer. It has also received clearance from the US Food and Drug Administration for clinical trials in five other cancers, including lung.
Dr Boynton added that Northwest is “especially pleased to achieve such a major milestone substantially ahead of schedule” and just a couple of weeks after the firm raised £15 million before expenses through a flotation on the AIM market of the London Stock Exchange. Investors were also pleased, pushing the firm’s shares up 37% to £1.41 and stormed up almost 250% on the Nasdaq to end the day at $7.33.