A current treatment, docetaxel (Taxotere) has some pretty bad side effects, but Provenge can extend life without the nasty chemo effects. What was a bit of a big sideline today was watching the stock, it was a real roller coaster, questioned and verified by Nasdaq. The Wall Street Journal has some of the news here.
This is probably one of the most dramatic stories over the last few years on the development of a drug. There were protests when the FDA denied it’s approval and wanted more information in 2007, death threats and law suits against those who allegedly had conflicts of interest on the FDA panel. Rallies were staged in Washington, so this is just a very brief recap in a couple sentences. About this time last year an anonymous backer helped supply some of the funds needed to keep the company going.
The company has had nine lives if not more and hopefully it will come to a good conclusion with the FDA when an application for approval is filed.
Suspense has been building for two weeks about just how good Dendreon’s big clinical trial results were going to be, and when the results finally came out today, fans of the company had nothing to be disappointed about.
Earlier in the day, we reported what readers needed to remember about the context of this trial, and then we reported the most essential facts when the data appeared. A clinical trial of 512 men, called Impact, showed that patients lived a median time of 25.8 months if they got Provenge, Dendreon’s experimental immune-booster, compared to 21.7 months for those on a placebo. This finding represents a 4.1 month advantage in median survival on the drug. The p-value, which tells statisticians whether this might have been due to chance, was 0.032, which is well within the FDA’s threshold to certify the finding as legitimate. Side effects were mostly fever and chills that lasted one or two days after injections.
The company plans to take its time to scrub through the records from the trial carefully as it prepares to turn in an amended application to the FDA in the fourth quarter of the year, Gold says. The FDA will then have as long as six months to complete its review of the application, he said.