A new stroke treatment with roots at the Oklahoma Medical Research Foundation is making progress in worldwide clinical trials. The medication, known as Cerovive, is based on discoveries made by OMRF scientist Robert Floyd, Ph.D.
Yesterday, the companies that are developing the drug announced a first analysis of data from a clinical trial involving more than 1,700 patients. Those companies, Renovis, Inc. and AstraZeneca, said that data show a statistically significant reduction versus placebo on the primary outcome of disability after an acute ischemic stroke (a stroke caused by a blocked artery), as measured by the Modified Rankin Scale. The incidence and profile of adverse events was similar to placebo.
“We’re quite encouraged by these results,” said OMRF’s Floyd. “The studies indicate that Cerovive is a very safe drug.”
“These data represent a real achievement in the development of neuroprotective agents for stroke,” said Corey S. Goodman, Ph.D., President and Chief Executive Officer of Renovis. “Cerovive is the first neuroprotectant treatment for acute ischemic stroke to show a statistically significant reduction of disability in a pivotal trial of this size and scope.”
Stroke is the third leading cause of death in the U.S. and the most common cause of serious, long-term disability. In this country, about 700,000 people suffer strokes each year.
AstraZeneca will continue trials to determine whether Cerovive, when administered up to six hours after a stroke, protects substantial portions of the brain that otherwise would have died. The trials are being conducted worldwide in hundreds of centers across 40 countries in Europe, Asia, Australia, New Zealand, South Africa, United States, Canada and Latin America. They are evaluating Cerovive’s effectiveness as a treatment for strokes caused both by blockage ant intracerebral bleeding.
The drug is given intravenously and is based on work that Floyd did almost two decades ago. In particular, the OMRF researcher was looking at free radicals – highly reactive oxygen molecules that can disrupt or kill brain cells. The work took an unexpected turn when Floyd and his team discovered that PBN, a compound he was using to capture free radicals, prevented brain injury, even when it was administered a full hour after a stroke.
“This really was a serendipitous discovery,” said Floyd. “Suddenly, we went from examining what happens in a stroked brain to potentially improving vision, mobility and speech in stroke victims.”
Cerovive is a compound closely related to PBN. Renovis, a California biopharmaceutical company, subsequently acquired the rights to the technology that arose from Floyd’s early discoveries. Renovis licensed those rights to AstraZeneca, the British pharmaceutical company that is now conducting the clinical trials.
“Right now, stroke patients have very few safe and effective options when it comes to protection against brain damage and other debilitating effects of stroke,” said Floyd. “If these trials prove successful, Cerovive could have a major impact on the lives of many, many people.”
Chartered in 1946, OMRF (www.omrf.org) is a nonprofit biomedical research institute dedicated to understanding and curing human disease. Its scientists focus on such critical research areas as Alzheimer’s disease, cancer, lupus and cardiovascular disease. OMRF is home to Oklahoma’s only member of the National Academy of Sciences.