From very early on, researchers and doctors have dreamed of using the body’s own immune system to fight cancer. The big question has been why doesn’t the immune system attack the tumor cells that invade healthy tissue? The really good news is that finally science is catching up with this vision. Therapeutic cancer vaccines that [...]
On March 10th (my birthday) Dendreon announced that it has obtained clearance of its new work stations from the FDA. The result of this clearance is the quadrupling the output from the New Jersey factory where it makes sipuleucel-T (Provenge). When Dendreon obtained FDA clearance in April of 2010, it had extremely limited manufacturing capabilities [...]
Bavarian Nordic A/S today announced that they have received a letter of concurrence from the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for a Phase 3 study required for product registration for its product candidate, PROSTVAC®, for the treatment of men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer [...]
Is there going to be a competitor to Provenge once it is approved? This is a very interesting question as a second investigational vaccine has shown a significant survival advantage in men with asymptomatic metastatic castration-resistant prostate cancer. There were just released updated results from a phase II trial of PROSTVAC-VF/Tricom vaccine. The trial had [...]
As my regular readers probably have noted from prior posts, I am a strong advocate for research and the development of a prostate cancer vaccine. A cancer vaccine is different from the more “common” types of vaccines that are familiar to us. The “common” vaccines (i.e. tetanus or polio) are administered prior to having an [...]