Pubdate: Tue, 23 Mar 1999 Source: PR Newswire Copyright: 1999 PR Newswire Author: Pharmos Corporation Note: While we seldom use press releases, this one is provided only because it shows how quickly a drug company moved to twist the IOM report to it's own commercial advantage. Subject line by MAP.


Patent Approval Follows Report Highlighting Medical Benefits of Marijuana

ISELIN, N.J., March 23 /PRNewswire/ -- Pharmos Corporation (Nasdaq: PARS) announced today 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 new patent defines novel therapeutic applications for the use of dexanabinol and other synthetic, non-psychotropic analogs of cannabinoids. In preclinical tests, Pharmos has demonstrated that dexanabinol could exert anti-inflammatory effects by preventing the production or release of Tumor Necrosis Factor (TNF) alpha. These compounds are also advantageous in that they do not produce certain side effects of other anti-inflammatory drugs used in the treatment of multiple sclerosis, such as steroids, and particularly in that they do not cause the psychoactivity of natural cannabinoids.

"We are very pleased with the granting of this patent," said Dr. Haim Aviv, Pharmos' Chairman and CEO. "Our expectations of dexanabinol having multiple neurological applications are confirmed by, among other factors, its amelioration of the severity of multiple sclerosis in animals. 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.

The patent allowance follows last week's much anticipated report from the National Academy of Sciences' Institute of Medicine (IOM) evaluating the medical benefits of marijuana. The IOM, which was commissioned by U.S. drug czar Barry McCaffrey, found that marijuana's active components are potentially effective in treating muscle spasms associated with multiple sclerosis, AIDS related anorexia, pain, nausea, and other ailments. However, due to the risks associated with smoking marijuana -- lung damage, cancer, and emphysema -- the drug should be administered by a safer, fast-acting, and reliable method. The report recommends that more clinical trials be performed to develop a smokeless alternative to treat patients.

The worldwide market for dexanabinol in the treatment of severe head trauma may reach $1 billion annually and is significantly larger if other neurological conditions such as multiple sclerosis and stroke are treated with the drug. An estimated 2.5 million people suffer from multiple sclerosis, which is most commonly found in the United States, Canada, Europe, and South America.

Pharmos Corporation is a pharmaceutical company specializing in the modification of existing molecules through proprietary techniques to reduce undesirable side effects and/or enhance efficacy.

This news release contains forward-looking statements that involve risk and uncertainties. The development of the company's products may differ materially from the company's expectations. Among the factors that could result in a materially different outcome are the inherent uncertainties accompanying new product development, action of regulatory authorities and the results of further trials