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.
In October, AstraZeneca said it was
delaying by a year its application to regulatory agencies for the experimental diabetes drug Galida. The company didn't find any problems with Galida, but it decided to postpone the filing date until 2007 to allow for an extra year of follow-up clinical trials.
And in December, follow-up clinical trials of the lung cancer drug Iressa showed there was no statistically significant difference in survival rates between patients taking the drug and patients taking placebo. The FDA approved the drug in May 2003 under a special protocol, and the agency is reviewing the recent test results. Iressa could be removed from the market.
The Cerovive study involved 1,700 patients in 400 medical centers in 40 countries; half received the drug, and half received placebo. The measurement favorable to Cerovive is called a Modified Rankin Scale, which assesses disability after an acute ischemic stroke, which accounts for 85% of strokes. This is caused by the interruption of the blood supply to the brain, such as a blood clot.
The measurement that showed no difference between placebo and Cerovive was the National Institutes of Health Stroke Scale, which evaluates neurological impairment. The two other clinical trials for the treatment include an extension of the acute ischemic stroke study and a study of Cerovive's treatment of adults with acute intracerebral hemorrhage, or bleeding in the brain caused by a broken blood vessel.