You'll note 72% out of the entire intent to treat population progressed and did not have any PR or CR, despite using radiation -- which should have made this far more possible near the outset given the nature of radiation therapy -- which is short tail centric. They used immature dendriritc cells in the Hasumi immunoradiotherapy study; and this might explain why they were only getting good results in patients with 5 or less tumors and/or tumors small enough to be eliminated by a 3cm or less diameter. Hasumi's ability to achieve a potent systemic response in the other patients who progressed is likely hindered by their immature dendritic cell not "overcoming" the tumor immunosuppressed environment, and consequently not maturing adequately to invoke a robust immune response in a high number of patients.
I surmise that NWBO's persistence in further perfecting their dendritic cell processing has given them the opportunity to have a superior product straight out of the gate. The final tweaks made in phase I of the phase I/II trial after almost a decade and a half research should provide robust durability.
If the same combinational immunotherapy with radiation were done with DCVax-Direct, I speculate the improvement over the Hasumi study would be striking. I suppose this could be a way to get faster approval, but at what cost (or benefit?) to durability remains a question. Perhaps only an additional experimental arm in one of the phase II trials can answer this.
The patients that did respond in the Hasumi trial had 377 days of progression free survival, and while there is no historical comparison given, again, it is my hope personal opinion that the durability in the DCVax-Direct trial will be longer in responding patients, particularly given booster shot availability and superior dendritic cells.
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