Dexanabinol

On March 15, 2004 Pharmos Corporation announced that it had completed patient enrollment in its pivotal Phase III study of dexanabinol for the treatment of severe traumatic brain injury (TBI). A total of 86 trauma centers recruited 860 patients. Pharmos expects to unblind the study data and announce initial results toward the end of this year.

The purpose of the double-blind, placebo-controlled study is to evaluate the efficacy and safety of dexanabinol as a neuroprotectant agent in severe TBI patients. Enrolled patients were given a single dose of 150mg dexanabinol or placebo within six hours after injury and received the standard care normally provided to TBI patients in intensive care units. The primary endpoint for the study will be patient outcome as measured on the Glasgow Outcome Scale – Extended (GOSE) six months after injury.

Physical trauma to the brain triggers a complex network of cascades that produce neuronal damage and death far beyond that caused by the initial insult. Dexanabinol, a tricyclic dextrocannabinoid, is thought to exert its neuroprotective effect through three mechanisms of action that suppress these toxic and inflammatory cascades induced by TBI: the inhibition of NMDA stimulated calcium influx, the inhibition of TNF alpha and other inflammatory cytokines, and free radical scavenging.

Annually in the United States, there are about two million emergency room visits for head injury, about 300,000 admissions for head trauma, and approximately 52,000 deaths. According to Pharmos Corporation, the annual market potential for a drug treating new TBI victims in the U.S. is over $500 million. Currently, there is no FDA approved product for the treatment of severe head injury.

Dexanabinol remains a Moderate Impact Technology in the Biohorizon Emerging Health Technology Database, with no assessment activities recommended at the present time for clients operating trauma programs. However, Dexanabinol has the potential to transform the management of patients with severe TBI and as such should be monitored closely over the coming months.

Technology Details
Target Disease / Indication
Traumatic Brain Injury

Technology Classification
Drug

Body System
Nervous System

Program Area
Medicine/Neurology

Regulatory Status
Phase III

BioHorizon Impact Score
51/100 – Moderate