Exceptional Survival Data, Lower Costs Key to the Competitive Advantage of DCVax®

Press releases may be edited for formatting or style | June 16, 2010

* NWBT is currently conducting a Phase II clinical trial (powered to serve as a pivotal trial) in Glioblastoma multiforme (brain cancer) in the US, which is set to resume recruiting once the company has completed a further round of financing. As the number of clinical sites within the trial increases, we see the potential for the trial to be halted at the time of interim data analysis based on strongly positive data. This should permit the launch of the first product for brain cancer in the US within the next three years.
* To date the survival data from using the NWBT technology in prostate cancer has been exceptional. Dendreon, which has a prostate cancer vaccine, Provenge, recently approved by FDA, has demonstrated median survival in pivotal trials of 25.9 months. NWBT's DCVax®-Brain has, however, demonstrated survival data in Phase I/II studies of 38.7 months, with 64% of patients surviving at three years (Provenge's three-year survival rate is 34%). DCVax®-Prostate has been cleared by FDA to begin a Phase III clinical trial, which we believe may serve as the pivotal trial.
* In glioblastoma, survival rates seen thus far with DCVax®-Brain are impressive - previous Phase I and Phase I/II trials have demonstrated a median survival of 36.4 months vs. standard of care (including Temodar) of 14.6 months. More than 69% of patients live beyond two years compared to 26% with standard of care.
* If DCVax®-Brain and DCVax®-Prostate are successful in their respective late stage trials and eventually approved, we see the potential for blockbuster sales for both products. More importantly, however, are other key advantages of NWBTs technology, which have not yet been appreciated by the market: the single-batch bulk manufacturing process (which enables far lower pricing than Dendreon's, and attractive margins); the high dendritic cell purity of the final vaccine (which enables simple intra-dermal injection like a flu shot, and enhances the vaccine's function); and, crucially, DCVax®-Prostate's patent position (which we believe is stronger than Provenge's patents outside the US).

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