Andrew Pollack, Walla News
You don't have to get to the hospital within 3 hours
After several failures over the past 20 years, an experimental drug has proven effective in protecting the brain from stroke damage.
In clinical trials with the participation of 1,700 people, the drug Cerovive reduced the physical limitations caused to patients following a stroke, as reported by the companies that developed the drug, "Renovis" and "AstraZeneca". Now another round of advanced clinical trials, defined as a "phase 3 trial", is being conducted. If the results, which should be received in the first half of 2006, are positive, an application will be submitted towards the end of next year for approval of the use of the drug, the companies said.
In the experiment, a significant statistical difference was found between the recipients of the period and those treated with placebo in the main index of the experiment - the index of the level of disability - but not all the findings of the experiment were positive: in another index - the index of neurological and cognitive function - no significant difference was found between the two groups. Nevertheless, Cerovive appears to be the first drug to protect brain cells from stroke damage that achieves its goal in a large phase 3 trial.
"There has never been a drug of this type developed that had a positive primary endpoint," said Dr. Mark Fisher, a neurologist at the University of Massachusetts, who added that dozens of drugs with the same goal had already been tried in the past. Fisher, who advises several drug manufacturers (but not the developers of Cerovive), said that if the second round of trials is positive, "this will be a revolution in the treatment of severe strokes."
The only drug approved so far for stroke lesions is Activase, also called tPA, manufactured by Genentech. The drug breaks down blood clots - the main cause of stroke. However, for the drug to be effective, the patient must receive it within three hours of the stroke. Most patients do not arrive at the hospital in such a short period of time. In addition, before receiving the medicine, the patient must undergo a CAT scan (computed tomographic imaging) to make sure that the stroke is indeed the result of a blood clot and not a blood vessel rupture; If the drug is given to a patient who has had a stroke due to hemorrhage, it will only make his condition worse. Because of these limitations, only 3% to 4% of people who have had a stroke are treated with tPA, said Corey Goodman, CEO of Renovis.
The effectiveness of Cerovive was proven in a clinical trial in which the drug was administered six hours after a stroke caused by a blood clot. About half of stroke victims arrive at the hospital in that time period, Goodman said. "AstraZeneca" and "Renovis" are conducting a separate trial that will test whether Cerovive does not cause damage to lesions in strokes caused by hemorrhage. If it turns out that it does not cause any harm, it will be possible to give it to all stroke victims without having to do a CAT scan first, Goodman said.
Cerovive is given by infusion for 72 hours and captures free radicals - molecules that can cause damage to cells. The drug will not save the brain cells that are close to the blood clot and die due to lack of oxygen, but it is designed to minimize the damage to a wider area of the brain, which may be caused in the days after the stroke.
The two companies did not publish the results of the experiment in detail and noted that they have not yet been fully tested. However, Dr. Justin Zivin, head of the team of researchers in the second experiment, said that in the first experiment the researchers were very close to obtaining statistically significant results in testing the improvement of neurological and cognitive function. According to him, the trial proved that one out of every twenty patients treated with Cerovive recovered completely. This is a lower rate than that achieved with tPA alone, but Cerovive also helped patients treated with both it and tPA.
The brain savant
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