ACT

Pharmos Corporation announced on 23 March that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a new patent entitled Tumor Necrosis Factor Alpha Inhibiting Pharmaceuticals, with claims covering the use of dexanabinol as well as various non-psychotropic cannabinoid analogs, derivatives or metabolites in the treatment of multiple sclerosis.

The non-psychtropic THC-derivative dexanabinol has been extensively examined in animal studies during the last years. It is effective in protecting brain cells against the effects of ischemia and hypoxia (decreased circulation and supply with oxygen). Dexanabinol exhibits pharmacological properties of a NMDA- receptor antagonist and is a novel inhibitor of TNF-alpha production. TNF-Alpha is a mediator (cytokine) produced by some immune cells, playing a role in inflammation, blood production, healing of wounds, and other important body functions. Dexanabinol might be used to treat brain damage following head trauma and stroke, and might neutralize the damaging effects of nerve-gas.

In preclinical tests, Pharmos has demonstrated that dexanabinol could exert anti-inflammatory effects. It does not produce certain side effects of other anti-inflammatory drugs used in the treatment of multiple sclerosis, such as cortisone, and it does not cause the psychoactivity of THC.

"Our expectations of dexanabinol having multiple neurological applications are confirmed by, among other factors, its amelioration of the severity of multiple sclerosis in animals," said Dr. Haim Aviv, Pharmos' Chairman. "Dexanabinol's neuroprotective properties could also be beneficial by preventing or decreasing the cumulative neurological damage caused by multiple sclerosis, which is a chronic degenerative disease. We are looking forward to the beginning of Phase III trials to confirm dexanabinol's efficacy in head trauma patients."

The recent completion of a successful Phase II clinical study showed dexanabinol to be safe and well-tolerated in severe head trauma patients. There were no unexpected adverse experiences reported for either the drug treated or placebo group. Intracranial pressure, an important factor and a predictor of poor neurological outcome, was significantly reduced in the drug treated patients through the third day of treatment, without a concomitant reduction in systolic blood pressure.

(Sources: ACM Bullettin 4.4.99)