For those who have come to the world of prostate cancer in the past 2 years or so, we recommend that, before you attempt to understand whatever happens on the day that Dendreon announces the results of the Phase III (IMPACT) trial of sipleucel-T, a.k.a. Provenge (expected some time this month), you read the well-constructed history of the clinical development of Provenge that has been posted to the Xconomy.com web site today.
This saga is a strange and complex mixture of medicine, money, egos, and individual opinions into which men with castration-resistant prostate cancer were thrown with limited appreciation of the bar room brawls that were going on on Wall Street, and which were affecting almost every perception of the product’s clinical value.
Would I like to believe that Provenge can prove its effectiveness as required by the clinical protocols that Dendreon agreed to? Yes I would. It is clearly a relatively safe form of treatment for late stage prostate cancer. In addition, its approval would be a vindication of all the money and scientific effort that has been invested to date in immunotherapeutic “vaccines” for the treatment of many cancers. Do I think that this is going to happen? In all honesty, I am very dubious about that. Have I ever held stock in Dendreon? No, I never have (except perchance unknowingly as part of a 401k plan).
ADDENDUM (as of April 4, 2009): Apparently it is possible (but not yet certain) that Dendreon will present the results of the IMPACT study on April 27 or 28 at the American Urological Association (AUA) annual meeting in Chicago. A company spokesperson has been quoted as stating that, “We have requested a potential late-breaker session [at the AUA annual meeting]. Once we have the data, we’ll disclose more details.”