Pharmos Journeys to Center of the Mind

Studies Under Way

To understand traumatic brain injury, think about someone who has been involved in a serious car accident. There might not be any penetrating trauma to the skull, but the violent force of the accident can cause injury to the brain, which in turn can cause permanent cognitive or physical disability. Simply put, someone who suffers from TBI is not able to function normally.

"I've been waiting for 10 years for a neuroprotectant to work in TBI, and dexanabinol has the best shot so far," says Harry Tracy, who runs the NeuroInvestment newsletter focusing on central nervous system therapeutics. (He's long Pharmos shares.)

Tracy likes dexanabinol's chances because the drug has three mechanisms of action to protect the brain from damage, whereas most of the previous drug failures only worked one way. Tracy also thinks Pharmos was smart about designing the current phase III study to minimize risks, learning from the mistakes other companies made.

The phase III study enrolled 867 patients who have the potential for moderate to severe TBI from accidents and who received dexanabinol within six hours of incurring the trauma. One group of patients was given dexanabinol intravenously as part of their overall treatment, the other a placebo. After six months, all patients will be assessed for TBI with a clinical measure known as the Glasgow Outcome Scale, a measure of physical and mental fitness after brain injury. Pharmos hopes to show that patients given dexanabinol exhibit a statistically significant reduction in TBI compared with placebo patients.

Pharmos is also testing dexanabinol to prevent cognitive problems associated with heart surgery. A phase II study in this indication is also under way, with results expected by the end of the year. While positive results in this study will be good news for Pharmos, the big event is the end-of -2004 results from the larger and more important phase III TBI study.

This is another of those all-or-nothing clinical events that high-risk-loving biotech investors crave.

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