Dendreon looks for early results on Provenge

Dendreon Corp. of Seattle said Wednesday that the final results of a study of its prostate cancer therapy Provenge would likely be available a year earlier than previously expected.

The results of the study are crucial to Dendreon because the Food and Drug Administration has indicated that if either the interim or the final results are positive, the regulatory body will review the therapy for approval a second time.

On the news, Dendreon's stock increased as much as 10 percent Wednesday before closing the day up 7 percent, or 36 cents, at $5.29 on the Nasdaq Stock Market.

Dendreon has concentrated almost all of its efforts on developing Provenge, although the company is expected to announce during a conference call Thursday that it will advance work on another product candidate.

Last May, the FDA said that Dendreon had to provide additional clinical data demonstrating Provenge's impact on patient survival before it approved the therapy.

The current study is designed to generate those data. While interim results are still expected in the second half of this year, final results are now expected in the second half of 2009 instead of 2010.

Because the study measures patient survival, a certain number of the 500 enrolled patients have to die before the data generated can be deemed statistically significant. The number of patients who must die has been reduced to 304 from 360. At the same time, though, the time frame when the interim results will be reported has been tweaked so that the results of the study will be just as meaningful.

Greg Schiffman, Dendreon's chief financial officer, said that so far the company had seen "events" -- or deaths -- "occur at a (rate) consistent with the company's model and expectations." However, he also said that the company did not have access to data showing how patients were responding to Provenge, compared with a placebo.

David Miller, president of Biotech Stock Research in Seattle, said that Dendreon had "shifted the trial around a little bit so that without damaging the chances of success they get an earlier look at the trial."