Israeli-American drug discovery company Pharmos Corporation (Nasdaq:PARS, Nasdaq Europe: PHRM) has found another use for dexanabinol, aside from treating traumatic brain injuries (TBI). Yesterday the company announced that it received approval from Israel's Ministry of Health to clinically test dexanabinol as a preventive agent against the mild cognitive impairment MCI - that can follow coronary surgery.
It turns out that patients undergoing cardiopulmonary bypass (CS-CPB) operations sometimes wake up in confusion.
The news of the ministry nod sent Pharmos stock surging 17% to 90 cents per share, pricing the company at $60 million.
Patient enrollment in a Phase II study will commence upon the completion of logistical preparations, the company said, adding that there is no approved treatment for cognitive confusion after cardiac surgery.
During cardiac surgery, the blood has to be temporarily rerouted through a heart-lung machine, explains Haim Aviv, Pharmos' chairman and CEO. The machine can be in use for a couple of hours. However, during that hiatus, particles blocking the blood vessels work free, and can create ischemic events - mini-strokes.
Put otherwise, the surgical process can charge a cognitive price. During recovery about 25% to 50% of patients often complain of disorientation and impaired memory, Aviv says.
In some cases the effect passes in a few weeks. But when checking patients six months to five years after the procedure, some 25% to 30% complain of a chronic problem.
$1.5 billion potential for improving the GOAT
The company carried out clinical trials of dexanabinol compared with placebos on about 100 post-traumatic patients at one, three and six months, Aviv says. The result was a significant improvement in orientation and memory, using the Galveston Orientation and Amnesia Test - GOAT.
About a million cardiac procedures are carried out a year around the world, Aviv says. The number is constantly growing, too, as the technology improves, partly because the age of patients for whom the surgery is feasible can be increased.
If Pharmos sells its treatment to patients in half these cases, and assuming a price of $2,000 to $3,000 for the drug, theoretically the company could achieve potential of $1.5 billion a year, Aviv calculates.
Sounds high, he acknowledges, yet the company believes it could reach that height within two to three years.
Meanwhile, Phase II clinical testing of dexanabinol will be carried out at Tel Aviv's Ichilov Hospital and at other medical centers in Israel. Some 100 to 200 patients will be given placebos as a control, Aviv adds.
The company has applied to the FDA ahead of starting Phase III clinical trials of dexanabinol starting in September or October, Aviv says.
"Post-surgical MCI is a serious risk facing patients who need major heart surgery," said Seth Kindler, medical director of Pharmos. "For certain subsets of patients, the risk of cognitive impairment is significant, compromising recovery and adding to rehabilitation costs.
"Development of post-surgical MCI is also a known risk factor for the progression to Alzheimer's disease. Our objective in undertaking this study is to evaluate safety and to establish a trend of efficacy with dexanabinol in these patients."
Dexanabinol is a neuroprotective compound that Pharmos developed from a synthetic tricyclic dextrocannabinoid compound. Dextrocannabinoids is a cannabis derivative that does not produce the psychotropic effects seen with natural cannabinoids. Drugs of this family have been found to reduce the necrosis and apoptosis caused by brain trauma and neurodegenerative disorders, the company explains.
Ilanot Batucha analyst Sophie Galper estimates that Pharmos will receive the FDA okay to start Phase III testing on dexanabinol, to treat TBI, toward the end of the year, after Phase II ended in 2000.