Israel’s Pharmos develops drug for traumatic brain injury

Dexanabinol keeps the brain from swelling up and crushing itself inside the skull and protects unharmed parts of the brain.There is currently no drug available for the No. 1 cause of death for Americans under the age of 34 – …

Dexanabinol keeps the brain from swelling up and crushing itself inside the skull and protects unharmed parts of the brain.There is currently no drug available for the No. 1 cause of death for Americans under the age of 34 – traumatic brain injury. But, later on this year, a drug invented in Israel may save the lives of American brain injury victims when it is used in the United States for the first time as part of a Food and Drug Administration clinical trial.

The drug, known as dexanabinol, was developed by Pharmos, an Israeli company traded on the Nasdaq stock market. The therapy is targeting a major health problem. Every year more than 500,000 people in the United States are hospitalized as a result of traumatic brain injuries. About 50,000 die, while many of the survivors suffer from permanent disabilities.

Given within six hours of a head injury, the drug keeps the brain from swelling up and crushing itself inside the skull and protects unharmed parts of the brain. “Most of the serious damage done to the brain of a TBI victim happens a number of hours after the initial injury,” said Dr. Haim Aviv, Pharmos’ chief executive officer. “It is during that window of opportunity that dexanabinol acts to halt the damage from spreading.”

The drug has already received a strong endorsement from the leading association of U.S. physicians in the field. Dr. Brian Andrews, chairman of the American Association of Neurological Surgeons described dexanabinol, while reviewing the results of the study conducted in Israel, as “the sort of treatment that we have been seeking for years and years.”

There are more than 5 million people in the United States living with TBI-related disabilities and the estimated cost for traumatic brain injury treatment and aftercare in the United States is more than $48 billion annually, according to the U.S. National Foundation for the Brain. It is estimated that sales of dexanabinol for traumatic brain injury alone could reach $500 million in the United States and $1 billion worldwide.

Pharmos is in the middle of a Phase III FDA clinical trial that includes tests on patients in Europe and is now seeking medical centers in the United States who will agree to administer the drug to qualifying head injury patients. The company hopes approval for selling the drug in the United States will come within a year or two after the end of the clinical trials, which should conclude next year.

Most traumatic brain injury patients are traffic accident victims like Asaf Yefet, a 20-year-old Israeli who was riding a horse when he got hit by a car, putting him in a coma for ten days that could have left him brain-damaged for life.

“The odds were against him,” said Dr. Nachshon Knoller, the neurosurgeon who treated him, speaking in a report broadcast on the CBS Evening News. “When he arrived in the emergency room he didn’t react to any commands, he didn’t open his eyes, he didn’t talk.”

What changed the odds in Asaf’s favor was an injection of dexanabinol.

Asaf, who today has resumed a normal life, was lucky that the doctors were able to reach his parents immediately after he was admitted to a Tel Aviv hospital. Because the use of dexanabinol remains experimental until regulatory trials are completed, next-of-kin consent must be obtained. Six hours is the maximum time allowable between injury and injection of the drug for the drug to be effective, creating an added sense of urgency for emergency room teams.

In addition to meeting this enormous need, dexanabinol also is expected to benefit the victims of a wide range of other types of brain injuries. A study carried out by the U.S. Army suggested that dexanabinol’s protective qualities could be effective in protecting the brain against damage caused by nerve gas exposure.

Other pre-clinical studies with dexanabinol, or with modified versions of it, have shown the new drug to be an effective treatment for other neurological conditions, especially stroke. Dexanabinol could even make its way from the emergency room to the sports stadium as a front-line treatment for concussions, which lack any approved drug therapy. Each year hundreds of thousands of Americans receive concussions and in contact sports, such as professional ice hockey, as many as 10 percent of players have received them.

Pharmos has raised money in the United States from institutional investors and on the Nasdaq stock exchange. Additional funding has come from the profits of two other drugs developed by the company – Alrex, for eye allergies, and Lotemax, for eye infections, which are both being sold in the United States.