July 26, 2002

By Gwen Ackerman

Jerusalem Post 

Pharmos Corporation, which sold its ophthalmic business to eye care giant Bausch & Lomb last year, is off and running with a whole new set of compounds derived from a cannabis–like compound.

The chemical compound, that imitates marijuana without inducing the same physiological effects, has already led to a treatment for severe traumatic brain injury, is called dexanabinol, which is in an international Phase III trial.

Thursday Pharmos received approval from the Health Ministry to clinically test dexanabinol as a preventive agent against the mild cognitive impairment (MCI) that can follow coronary surgery. The double-blind, placebo-controlled trial is due to be carried out at the Tel Aviv Sourasky Medical Center on a group of up to 200 patients.

“The commencement of this study is an important strategic move that broadens our pipeline,” said Haim Aviv, chairman and CEO.

“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.”

Cognitive loss following cardiac surgery was not considered a major problem until two years ago, when a study showed that the memory loss caused by a blockage of blood flow to the brain that followed the surgery was long term.

“Post surgical MCI is a serious risk facing patients who need major heart surgery,” said Seth Kindler, Medical Director of Pharmos. “Development of post-surgical MCI is also a known risk factor for the progression of Alzheimer’s Disease.”

Dexanabinol has shown itself to be a successful in significantly improving cognition and orientation in a traumatic brain injury cases during trials performed in Israel. “Since our drug is protecting a brain that doesn’t get blood supply, we decided to do a trial on bypass surgery patients,” said Aviv.

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 US before it will be available in the market. If dexanabinol proves successful in treating the cognitive impairment, it will have a lucrative market.

There are more than one million cardiac operations performed annually around the world, with up to 35 percent of the 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, and in its pipeline is a sister compound that appears to be particularly effective in protecting vein damage after blood flow is blocked. The research is currently on hold while Pharmos looks for a large company to partner 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 cannot undertake the $30-40m. commitment for the stroke trial,” said Aviv.

But the company does not intend to stop with stroke victims. It has also designed a family of new cannoboid type structures that bind to certain receptors in the body and alleviate long term or neuropatic pain, such as that felt by cancer patients, arthritis sufferers, and diabetics.

Currently there is no good treatment for these types of pain, said Aviv.

Morphine is not that effective, as it is designed for the acute pain that immediately follows surgery, and it has unpleasant side effects as well. The anti-inflammatory drugs currently used are beneficial only in very mild situations.

Pharmos has developed a prototype over the past two years and is currently testing a number of compounds and readying for animal toxicology work.

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.

Publicly traded on Nasdaq and headquartered in New Jersey, Pharmos has a staff of 60, 50 of whom work in R&D labs in Rehovot.