Just about everybody is getting shelled in the market these days, but Dendreon Corporation shareholders just hit a gusher. Dendreon’s stock soared 36% Monday on positive news from an interim analysis of its prostate cancer immune therapy drug, Provenge.
Two years after randomization, the trial shows that the vaccine-treated group had 22% fewer deaths than the placebo group. In addition, safety concerns have not surfaced. Although favorable, these results did not compel scientists to halt the trial and trigger an amended FDA filing.
The study should conclude in mid 2009. From that point, the FDA has 6 months to review the results.
These interim findings are similar to those observed in a previous trial of Provenge which prompted an FDA advisory panel to report that Provenge had proven to be safe and effective. Rather than accepting the panel’s recommendation, the FDA ordered another study.
Many analysts doubt the positive interim findings will stand up. Bank of America analyst William Ho for example, said “considering the totality of the data available, we are skeptical of a positive outcome of the final analysis of the…trial.”
Dendreon wants Provenge approved for asymptomatic men with advanced prostate cancer that is no longer responsive to hormone therapy.
Provenge is the first immune therapy drug to achieve positive results so late in the approval process. Other cancer vaccine companies are IDM Pharma, Progenics Pharmaceuticals and Antigenics.