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Reefrad

04/06/14 7:37 PM

#8207 RE: S_mack #8204

There are 2 main reasons why Direct is the future of L. One is a logistical hurdle that L has to overcome and Direct does not. For L you must first surgically excise tumor specimen to educate the dendritic cells in-vitro (out of the body). So basically the patient has to undergo a surgical procedure. With Direct you inject the dendritic cells directly in to the tumor via ultrasound guidance. The other major difference is that Direct uses the 2nd generation of dendritic cells. Recall that L was engineered over 5 years ago. Recently NWBO put out a patent for the new and improved dendritic cells that are supposed to be exponentially better at activating the immune system. Because the L trial was already under progress these newer cells could not be used in the current PIII but they are being used in the I/II Direct trial.

Finally, there is no reason to believe that there will be anything but a systemic response in the case of metastatic disease. If you assume that the dendritic cells are effective at activating the immune system then they will do just that. Just like when your immune system fights the flu globally even though the initial interaction was a localized event.
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Reefrad

04/06/14 7:59 PM

#8208 RE: S_mack #8204

One other issue is inherent in the indication of Direct. Think about it, "All inoperable tumors". What does that mean to you? Its not just the rare sarcomas or other obscure malignancies. This includes, potentially, any solid cancer (which is pretty much everything but leukemia) that is too advanced in its stage for surgery to be curable! So while no one is suggesting that you leave the 1 cm lung cancer in the patient in lieu of administering Direct, how many patients present with a 1 cm lung cancer? Not many (which is part of the reason why cancer is the number 2 killer in the developed world, behind cardiovascular disease). So all those patients who have unresectable cancer (lung, prostate, breast, pancreatic, any GI, even hepatic) can stand to benefit from Direct, as long as they are advanced enough (which as I've already stated, is the majority with the exception of breast and cervical which are heavily screened for).