Dendreon's Provenge Trial: Big Step On Bumpy Road
It isn't moving the stock, but Dendreon this morning announced that it has signed up all of the patients for the big clinical trial that could lead to its prostate cancer drug, Provenge, winning Food and Drug Administration approval.
The completion of enrollment was not unexpected, so that's why people aren't trading on the news. Nonetheless, it's another step forward on the long, bumpy road for Provenge.
And another excuse for me to blog about this company which, as I've mentioned before, drives traffic. I've even heard through the grapevine that a certain web-based biotech reporter has been told by her/his editors to try to work the name "Dendreon" into as many articles as possible simply because it results in such a huge spike in page views.
So, DNDN has more than 500 patients participating in the clinical trial which is taking place at more than 70 sites in North America. It's not a surprise that it was able to quickly get people to sign up for the test since advanced prostate cancer patients have little else left to try and the buzz in the prostate cancer community is that Provenge holds great promise. But the men enroll knowing that they could get the real thing or a placebo.
Each patient will get three big blood draws over the course of a month or so and then the blood is mixed with the Provenge/placebo and reinfused back into their bodies. The company says the interim analysis of the data will be done in the second half of next year. If they show in those sneak-peek results that Provenge appears to extend patients' lives that could lead to FDA approval.
However, in a research note to clients this morning, Rodman & Renshaw biotech analyst Ren Benjamin writes, "…we continue to believe that the likelihood of achieving a statistically significant result at interim is low…." Benjamin cites three reasons for his opinion:
1. Therapeutic cancer vaccines may take longer than conventional chemo to show a positive effect.
2. Interim data have what he calls a high statistical hurdle to clear.
3. And it's just too tough to handicap interim results. R&R makes a market in DNDN.
Unlike Dendreon, Merck is on the move again today. After jumping on a strong earnings report yesterday the shares of the Dow component are up another buck as I write this on a slew of bullish analyst commentary this morning and have hit a new intra-day high of $55.84, so far.