MEDIA ADVISORY September 30, 1998
Contact: Barbara Peck, Congress of Neurological Surgeons, (847) 692-9500, [email protected]
Gwyn Crosson, Pharmos Corporation, (732) 603-3526
Results Of Study Examining The Neuroprotective Efficacy Of Synthetic, Non-psychotropic Marijuana In Severe Head Injury Patients To Be Released
Nachshon Knoller, MD, principal investigator of a Phase II study, will present the results of a two-year study on the efficacy of dexanabinol (HU-211), an analog of the active agent in marijuana, in treating severe head injury patients. The results of the trial will be presented at the 48th Annual Meeting of the Congress of Neurological Surgeons on October 7, 1998, in Seattle, Washington.
"If dexanabinol is successful as a neuroprotective agent, it might become a standard inclusion in the kit bag of every medic and ambulance," said Dr. Knoller, a neurosurgeon at the Sheba Medical Center in Israel.
More than 373,000 Americans are hospitalized for severe head injuries each year, and more than 99,000 of these individuals sustain moderate to severe brain injuries that result in lifelong disabling conditions. Head injury is the leading cause of death among children and young adults in the U.S.
"Often times it is not the initial head injury that is the problem, but the ensuing chemical reactions in the brain following the injury that lead to cell death and consequently permanent brain damage," said Brian T. Andrews, MD, a neurosurgeon at the University of California - San Francisco and Chairman of the CNS Section on Neurotrauma. "This treatment has the potential to stop some of those chemical reactions."
Dexanabinol also has the potential to impede the brain-cell deterioration from seizures that accompany nerve-gas and biological attacks by neutralizing the calcium or oxygen overflow for several minutes after trauma is experienced. In recent trials conducted by the U.S. Army Medical Research Institute, brain damage exposed to lab rats and treated with dexanabinol five minutes later was reduced by 75 percent.
Dexanabinol has three independent mechanisms of action: it blocks glutamate-induced neurotoxicity; it scavenges both peroxy and hydroxy free-radicals; and it inhibits the action of the inflammatory cytokine, tumor necrosis factor alpha. These reactions occur in the brain after an injury is sustained.
The head injury Phase II multi-center, double blind, placebo-controlled, randomized trial was conducted in association with the American Brain Injury Consortium at head trauma centers in Israel. Phase III trials will be conducted in the United States. Dexanabinol is a product of Pharmos Corporation, Iselin, New Jersey, who underwrote the Phase II trial.
Patients in this study received a single injection of dexanabinol within six hours of the initial head injury. So far, 67 patients have been followed over a six-month period using standard clinical tests and scales such as the Glasgow Outcome Scale (GOS) and Disability Rating Score (DRS). Demographic analysis indicates that this patient population is representative of the characteristics describing the average severe head trauma patient, which are often young males with motor vehicle accidents as the primary cause of injury.
The results that will be presented on October 7 will compare the outcome of the placebo group versus those patients who received dexanabinol.
The Congress of Neurological Surgeons, founded in 1951, is a professional medical association of nearly 4,200 members devoted to the advancement of neurological surgery. Neurological surgery is the medical specialty concerned with the diagnosis and treatment of disorders affecting the brain, spine and peripheral nerves. The 1998 Annual Meeting of the CNS will be held October 3 -8, 1998, at the Washington State Convention Center in Seattle, Washington.
Pharmos Corporation is a pharmaceutical company engaged in the redesign, development and commercialization of proprietary products that enhance the efficacy of existing compounds and reduce their side effects. The Company focuses primarily on drugs for post-surgery and allergy-related eye-care, neuroprotective agents for the treatment of central nervous disorders, newly designed molecules for the treatment of cancer and unique delivery products.
For more information on this study and others being presented at the 1998 CNS Annual Meeting, please visit the online CNS Press Room located in the Virtual Exhibit Hall at http://server400.aans.org/VEH/
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Media: The results of the study will not be released prior to 8 a.m. on October 7. Dr. Knoller will be available to discuss the results of the study via teleconference from Seattle at 10 a.m. PST on October 7. If you wish to take part in the teleconference, please contact Barbara Peck, at (847) 692-9500 prior to October 2, or in the CNS Press Room (206) 505-6476 on or after October 5. For additional background information prior to the release of the results, please contact either the Congress or Pharmos at the above phone numbers.
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