(AZN - Get Report)
reported mixed results for a late-stage clinical trial of an experimental drug for treating stroke but said it hopes to submit the product for regulatory review during the second half of 2006.
At the same time, the shares of another company involved in the product's development were nearly doubling in heavy trading Wednesday.
The clinical trial involved Cerovive, one of the few AstraZeneca drugs in late-stage clinical development. According to preliminary results, patients taking Cerovive demonstrated statistically significant improvements compared with patients taking a placebo, according to one measurement. But when applying another standard for testing stroke patients, researchers found no significant difference between the two groups.
AstraZeneca said the results must be evaluated along with two other clinical trials now under way. The company said its applications to regulatory agencies will depend on the outcomes of all three clinical trials.
"We are encouraged by these data," said Dr. Thomas Odegren, who is directing Cerovive research at AstraZeneca. "The full potential of Cerovive will only be clear after completion of the clinical development program."
AstraZeneca is developing Cerovive under license from
, a tiny biotech company based in South San Francisco, Calif.
Cerovive is Renovis's leading product under development, and the company's stock jumped $6.51, or 96%, to $13.30 in morning trading. The stock has been as high as $15.04. Average daily volume for Renovis is about 210,000 shares, but in the first 75 minutes of trading Wednesday, more than 8.8 million shares changed hands. AstraZeneca gained 5 cents to $44.67.
Important to Both Companies
There's little doubt what Cerovive means to Renovis, but the drug also is important to AstraZeneca, whose recent research efforts have suffered setbacks. In September, a Food and Drug Administration advisory panel opposed the company's application for the
experimental anticoagulant Exanta
, saying the risks of liver damage outweighed the drug's benefits. The FDA backed the panel's opinion a month later.