Phase III human trials on the effectiveness of the synthetic marijuana derivative Dexanabinol for the treatment of Traumatic Brain Injury (TBI) are pending for the first time in the U.S., according to a recent press release by the Pharmos Pharmaceutical corporation.
"The U.S. arm of the study [is] planned to begin in 2002 pending the submission and acceptance of an IND [Investigational New Drug application]," the release states. "Completion and enrollment is anticipated in 2003."
Presently, nine nations - Belgium, England, Finland, France, Germany, Israel, Italy, the Netherlands and Spain - are taking part in the ongoing, worldwide study.
A previous Phase II trial of 67 Israeli patients by Pharmos demonstrated that Dexanabinol reduced mortality and eased intracranial pressure in patients suffering from severe head injuries. A 1998 U.S. Army rat study also reported that the administration of Dexanabinol five minutes after the onset of nerve gas-induced seizures significantly reduced brain damage.
Similar research conducted by scientists at the National Institutes for Mental Health found that naturally occurring cannabinoids THC and cannabidiol (CBD) are neuroprotective in animals. A 1999 report by the National Academy of Sciences' Institute of Medicine (IOM) called cannabis' neuroprotective qualities the "most prominent" of its potential therapeutic applications.
For more information, please contact Paul Armentano, NORML Director of Publications and Research, at (202) 483-5500.