Dendreon Corp. said Wednesday the Food and Drug Administration agreed to an accelerated timeline for its late-stage clinical trial of Provenge, the biotechnology company's prostate cancer treatment candidate.
The FDA agreed to amend its special protocol assessment with the new timeline. An SPA agreement generally reduces the risks involved in developing a drug because the drug maker and the FDA agree ahead of time on how the trial will be conducted, and what will be considered proof that the drug works.
The amended SPA speeds the expected timing of the final results by about one year to the second half of 2009. Interim results are still expected in the second half of 2008.
Earlier this month, Cell Genesys Inc. announced that a midstage study showed that its GVAX vaccine accomplished a key goal of simulating the immune system to fight tumors. The vaccine is potentially a key competitor of Provenge.
Shares of Dendreon rose 47 cents, or nearly 10 percent, to $5.39 in morning trading.
