Dexanabinol, Pharmos’ drug for brain injury, is being tested for effectiveness against brain impairment following heart surgery.Pharmos Corp. is working with a whole new set of compounds derived from a cannabis-like drug that has already proved successful in improving the condition of patients with traumatic brain injuries.
Pharmos has received approval from the Israeli health ministry to test the chemical compound, known as dexanabinol, in clinical trials as a preventive agent against the mild cognitive impairment that can follow coronary surgery. The double-blind, placebo-controlled trial will be done at Tel Aviv Sourasky Medical Center on a group of up to 200 patients.
Dexanabinol imitates marijuana without inducing the same physiological effects. The drug, which is in an international Phase III clinical trial for use against traumatic brain injury, stops the inflammation of the brain, blocks the toxic release of dying cells, and has already saved the lives of several traffic accident victims in Israel.
Pharmos is headquartered in New Jersey, but carries out its pharmaceutical research at a lab in Rehovot, Israel.
“The beginning of this (cardiac surgery) study is an important strategic move that broadens our pipeline,” said Haim Aviv, Pharmos’ chairman and chief executive officer. “The potential market is large and currently void of any product. At the same time, the large, relatively homogeneous patient population and elective nature of the surgery make the trial a fairly uncomplicated one for us.”
Loss of brain function following cardiac surgery was not considered a major problem until two years ago, when a study showed a possibility of long-term memory loss caused by a blockage of blood flow to the brain after surgery.
“Post-surgical (brain impairment) is a serious risk facing patients who need major heart surgery,” said Seth Kindler, medical director of Pharmos. “It is also a known risk factor for the progression of Alzheimer’s Disease.”
The preliminary testing cycle of dexanabinol on cardiac surgery patients is likely to take six months, after which several more studies must be done in Europe and the United States.
The market for such a therapy appears promising. There are more than one million cardiac operations performed annually around the world, with up to 35 percent of patients suffering some type of cognitive impairment that leads to a health care cost per patient of $250,000 over five years.
Pharmos intends to expand dexanabinol’s benefits to stroke victims as well. The company has produced a sister compound that appears to be particularly effective in protecting vein damage when blood flow is blocked following a stroke. The research is on hold while Pharmos looks for a large company to partner with in the trial.
“We have the money for the clinical trials we are currently undertaking for the brain injury treatment (which is being done in 60 centers in Europe), but we can’t undertake the $30 million to $40 million commitment for the stroke trial,” Aviv said.
Pharmos also has a family of compounds that bind to certain receptors in the body to alleviate long-term pain.
There is no good treatment now available for these types of pain, Aviv said. Morphine is not that effective, as it is designed for the acute pain that comes immediately after surgery, and it has unpleasant side effects as well. The anti-inflammatory drugs now used are beneficial only in very mild situations.
Pharmos has developed a prototype over the past two years and is testing a number of compounds and readying for tests on animals.
The biggest challenge in the development of the drug is to alleviate the pain without causing the behavioral changes that are seen in those who regularly smoke marijuana, according to the company.