Shares of Cortex Pharmaceuticals got hammered on Wednesday when the company announced that a Phase II study to determine its lead drug's effect on wakefulness failed to demonstrate a greater effectiveness than a placebo. The study simulated night shift work among subjects taking CX717 and was funded by the Defense Advanced Research Projects Agency. The results differed markedly from an earlier study, and Cortex says a difference in the way the studies were designed may have played a role in the disappointing results. Cortex plans to focus now on the therapy's effectiveness against ADHD.
"We also remain committed to the program in Alzheimer's disease as we await the results from our Phase II study in that disorder," said Dr. Roger Stoll, chairman and CEO of Cortex. "Moreover, we anticipate having the opportunity to conduct additional studies on sleep disorders with either CX717 or with CX701, a back-up compound that should enter clinical trials early next year."
- here's the AP report on the Cortex trial