Reuters
Synthetic marijuana compound tested for brain injuries
Tuesday July 1, 5:34 pm ET
By Deena Beasley
LOS ANGELES, July 1 (Reuters) - Pivotal-stage U.S. testing was launched this week to see whether a synthetic derivative of marijuana might be the first effective treatment for traumatic brain injury.
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Pharmos Corp. (NasdaqSC:PARS - News), a drug developer based in Iselin, New Jersey, on Tuesday said it initiated U.S. enrollment in a Phase 3 trial of dexanabinol, a version of the active ingredient in cannibis that has been designed not to bind to receptors that stimulate the psychotropic effects seen with naturally-occurring cannabinoids like marijuana.
The compound is already being tested in 60 international trauma centers. Results from the 900-patient trial are expected by the fourth quarter of next year, according to Pharmos Chief Operative Officer Gad Riesenfeld.
"When you have ischemia in the brain -- caused by a car accident, a stroke, or other injury -- the result is inflammation, apoptosis and necrosis. Brain cells are eventually killed and some people will die," he said.
Pharmos says dexanabinol protects against neurological deterioration in three ways -- it is an anti-inflammatory compound that can slow the breakdown of the blood-brain barrier and cell death, it prevents the lethal massive influx of calcium ions into the cells of the injured brain, and it is an anti-oxidant, acting to protect the brain by scavenging free radicals that are formed when an injury is sustained.
"Neurosurgeons and their patients as well as all other emergency medical personnel are in serious need of an effective medication that can protect the brain from severe damage in injured patients and thereby improve neurological outcome," said Dr. Raj Narayan, chairman of the Department of Neurosurgery at University of Cincinnati.
About 52,000 Americans die each year from head injuries, while another 80,000 suffer long-term disability.
In an earlier Phase 2 trial -- U.S. regulators typically require an experimental drug to be tested in three stages -- dexanabinol was shown to reduce brain swelling and improve responses such as memory, while a trend toward improved outcomes was seen.
The Phase 3 trial seeks to prove that the compound -- injected once within six hours of injury -- results in better patient outcomes based on a scale that ranges from death to a resumption of normal life.
Patients eligible for the trial must fall in the mid- to upper range of a different designed to measure the severity of coma. They will be given standard care in addition to either dexanabinol or placebo.
In the United States, the drug could be a treatment for about 150,000 out of an estimated 1.5 million annual head injuries, Riesenfeld said.
Pharmos estimated the the worldwide market for the product could exceed $1 billion annually. The company's shares rose 7 cents, or 3.4 percent, to close at $21.3 on Nasdaq. |
