Swiss approval for brain cancer vaccine

[RandyW]

Northwest Bio gets Swiss approval for brain cancer vaccine

LONDON - Northwest Biotherapeutics Inc, a US-based biotech company which listed in London last month, said its therapeutic brain cancer vaccine has received approval in Switzerland 'substantially' ahead of schedule.

The news prompted shares in the company to jump 12 pct in early trade.

The company claimed that DCVax-Brain will be the first commercially available therapeutic vaccine for such cancers in the world.

Therapeutic vaccines differ from normal vaccines, in that they are given to patients with a pre-existing condition to stimulate the immune system.

In trials DCVax-Brain has been shown to delay disease recurrence in newly diagnosed patients by nearly three-fold, and more than the double survival time. The therapy also does not cause the debilitating side effects associated with treatments such as chemotherapy.

Brain cancers take hold rapidly and current treatments are limited. Newly diagnosed patients will on average survive around 14.6 months.

Northwest said it will begin selling the vaccine in the third quarter of the year in select centres in Switzerland.

Shares in the company, which is also listed on Nasdaq, were trading 12 pence higher at 114 at 9.00 am. The stock floated on AIM on June 22 at 95 pence.

DCVax-Brain is currently in a registration trial in the US involving 141 patients, which should conclude around the end of 2008. Approvals will be sought in both the US and EU in early 2009, based on the results.

The therapy has been granted orphan drug status in both regions, which can mean a swifter approval process, and longer market exclusivity.

DCVax is a platform technology which Northwest is developing for a range of cancers. A phase III trial in prostate cancer is ready to begin, following encouraging results from earlier studies, while US regulators have given the go-ahead for research in five other cancers, including lung.

Each DCVax treatment is personalised, and made by combining a patient's own master immune cells with cancer biomarkers found on his or her tumour. When injected back in to the patient, it mobilises the immune system to attack the tumour.

Northwest said using its manufacturing process, a single run can produce at least three years of personalised treatments for a particular patient, keeping costs down. The vaccine can be priced in a range comparable to other cancer drugs, it added.

Copyright AFX News Limited 2007