From AOL:
Israeli firm says head injury drug shows promise
By David Rosenberg
JERUSALEM, Oct 7 (Reuters) - A new drug based on a synthetic analogue of marijuana showed promising results in treating people with severe head injuries, an Israeli pharmaceutical company said on Wednesday.
Israel's Pharmos Corp said in a statement that trials with 67 patients showed that the drug, dexanabinol, eased intracranial pressure, reduced mortality by 26 percent and enabled a higher percentage of patients to resume a normal life.
''These study results are promising and open the door to a Phase III study in the U.S. and Europe next year,'' chairman and CEO Haim Aviv said in a statement.
''No drug is currently approved to treat severe head trauma, the leading cause of death among children and young adults in the U.S.,'' the company said.
The potential market for dexanabinol, is between $500 million and $1 billion, depending on which conditions it is eventually approved for, Pharmos said.
''There is a very large unmet need,'' Aviv said. ''In the U.S. 370,000 patients a year are hospitalised for severe head injuries. Worldwide it's at least twice that.''
Aviv told Reuters Pharmos now hoped to complete talks with one of several major U.S. and European pharmaceutical companies on an agreement to finance the next stage of trials in exchange for rights to market dexanabinol.
''Our strategy is to partner with a larger group,'' Aviv said. ''We have been in discussions with a number of companies and we're waiting for completion of Phase II.''
He estimated the Phase III study, involving trials with 700-900 patients in the United States anxd Europe, would take 18-24 months to complete at a cost of $15-20 million.
''It will take at least two years and possibly three years for (U.S. Food & Drug Administration) approval,'' Aviv said.
10:31 10-07-98 |
