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The Company researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases.
I won't get too deeply into statistical analysis of Allovectin phase II data and the phase III performance of comparators. The reason for that is people will never see eye to eye regarding the utility of comparing survival in single-arm trials to historical data. I personally don't feel the comparison is valid, but if you do believe in it then the Allovectin phase II data looks pretty good.The real reason behind my red thumb here is the high rate of failure of phase III trials of immunotherapeutics, and the high rate of failure in phase III trials in melanoma. Yes, there are just enough candidates that squeak by such as Provenge and Yervoy to keep life interesting. But the historical odds against Allovectin are high.The timing of phase III data release has been pushed back indefinitely due to a lower-than-expected death rate in the trial. I've seen this same issue touted as a guarantee of trial success in many other cases, only for those hopes to be squashed when the real reason turned out to be better-than-expected comparator numbers. I'm expecting the phase III trial to reveal no stat sig survival benefit of Allovectin, attributed to survival with dacarbazine better than historical performance. 24 week response rates could be higher with Allovectin, but without the survival benefit that has been shown with Yervoy and Roche's vemurafenib the drug is likely dead in the water commercially.
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