Dendreon

Dendreon is a company that's really been through it, as have their investors. Many will remember the upheaval back in 2007, when the company showed what they felt were impressive results for their autologous prostate cancer immunotherapy Provenge, got a favorable reception from the FDA's advisory panel, but were then hit with an "approvable" letter asking for more data. (Here are three posts on that: before, during, and after).

Dendreon’s long-awaited big news is coming tomorrow morning. The Seattle biotech company (NASDAQ: DNDN) said it will hold a conference call before stock trading opens tomorrow morning to discuss the final results of a clinical trial that will show whether its immune-stimulating drug for prostate cancer, Provenge, can help men live longer.

The company’s conference call will start at 9 am Eastern time/6 am Pacific, about a half-hour before trading opens. The company didn’t tip its hand one way or another in its statement today, but it’s important enough that trading was halted in the stock prior to the announcement. Plenty of people are already betting big that Dendreon is going to have positive results from this trial, called Impact, of 500 with terminal prostate cancer. Shares climbed 16 percent today to close at $7.30, on about quadruple the average trading volume.

Provenge

Provenge, an immune therapy for certain forms of prostate cancer, provides statistically significant survival benefits for patients. We have actually known this for almost two years, but the last time around the FDA decided to ask for a larger study to verify the earlier results.

The new study, a Phase III trial named IMPACT, enrolled 512 patients with metastatic androgen-independent prostate cancer, a late-stage cancer than usually kills men in a few months. The trial showed that on average men lived over 20% longer when they had received the Provenge treatment. The exact statistical results will be presented at a medical conference shortly.

This is going to have a major impact on the entire biotechnology industry. If the FDA now approves Provenge, as expected, it will be the first approved immunotherapy. Immunotherapy research has been stifled by lack of funds because the FDA had never approved a therapy. When sales of Provenge begin, Dendreon should have the funds to both improve its therapy for prostate cancer and to create therapies for other forms of cancer.