"Northwest Biotherapeutics, Inc. (OTC Bulletin Board: NWBO; AIM: NWBS and NWBT), is pleased to announce that it has received Authorization for Use from the Swiss Institute of Public Health (Bundesamt fur Gesundheit; "BAG") to make DCVax®-Brain commercially available for treatment of brain cancer patients in Switzerland. As such, DCVax®-Brain is the first commercially available therapeutic vaccine for such cancers. The Company intends to begin making the product available to patients in Q3 2007."
Tiny is right -- market cap < $10 million, 3 full-time employees (per Yahoo.)
>>In parallel with making DCVax®-Brain commercially available to patients at selected medical centers in Switzerland, NWBT is also conducting a Phase II pivotal trial in 141 patients in the US. The trial began enrolling patients in December 2006, and is anticipated to conclude around the end of 2008. The Company plans to seek product approval in both the US and EU in early 2009, based upon the results of the Phase II pivotal trial.
DCVax®-Brain has been granted orphan drug status in both the US and the EU. Such status will afford DCVax®-Brain 7 years of market exclusivity in the US and 10 years in the EU, if DCVax®-Brain is the first product of its type to reach product approval.
Clinical trial data to date in brain cancer patients have shown that DCVax®-Brain delays disease recurrence by nearly 3-fold, from 6.9 months to 18.1 months for newly diagnosed patients. DCVax®-Brain also extends these patients' survival from 14.6 months to more than 33 months (and continuing -- median not yet reached).
The DCVax® Technology platform is anticipated to be applicable to most cancers. NWBT is already at the Phase III, pivotal trial stage in prostate cancer, and has also received FDA clearance for clinical trials in five other cancers (including lung cancer, the leading cause of cancer deaths worldwide). Clinical trial data to date in hormone independent prostate cancer patients have shown striking results similar to the results in brain cancer
About Northwest Biotherapeutics, Inc.
Northwest Biotherapeutics, Inc. is a US-based biotechnology company focused on developing immunotherapy products that treat cancers more effectively than current treatments, without toxicity, on a cost-effective basis.
The Company has two broad platform technologies:
(1.) dendritic cell-based therapeutic vaccines and (2.) antibody drugs. The Company's lead product candidates are:
1. DCVax®-Brain, a personalized dendritic cell vaccine for treatment of Glioblastoma multiforme, which has reached the market commercially in Switzerland and, in parallel, has been under way since December, 2006, in a Phase II pivotal clinical in the US which is expected to finish around the end of 2008; and
2. DCVax®-Prostate, a personalized dendritic cell vaccine for treatment of hormone independent non-metastatic prostate cancer, which has been cleared by the FDA to enter a Phase III pivotal clinical trial in the US.
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