The market seems to be waiting for Biomira's Phase III trial to prove Theratope works to a statistically relevant degree. But, he adds there have been some high-profile disappointments. For example, doctors temporarily pulled the plug on Tarrytown, Progenics Pharmaceuticals' Phase III trial of the melanoma vaccine GMK after interim analyses revealed it caused patients' skin cancer to relapse faster. Another competitor, Corixa, scored Canadian marketing approval for its melanoma fighter, Melacine, only to be asked to supply further clinical data before Americans will OK the product. More important, though, is the question of whether Theratope's earlier Phase II trial holds water.
Conventional wisdom holds the placebo method to be a more stringent measure of a drug's efficacy.
But there are compelling reasons to bet on Biomira.