May 20, 1998 12:59 PM news release NEOT
DOW JONES INTERNATIONAL NEWS SERVICE
NEOTHERAPEUTICS' ALZHEIMER DRUG TRIALS SHOW MEMORY GAINS
MILAN (Dow Jones)--A small Irvine, California-based company is one step closer to finding an effective treatment for Alzheimer's disease and for curbing brain damage after a stroke.
Neotherapeutics Inc. (NEOT) Chief Executive Alvin Glasky told Dow Jones Newswires Wednesday that limited clinical trials found patients given the company's AIT-082 compound showed memory and behavioral improvements.
"We're seeing memory improvement with one dose," said Glasky, in Italy for a medical conference during which he will announce details of the trials. "There also have been behavioral improvements, care-givers are telling us. People who didn't speak who are now talking."
Some four million people suffer from Alzheimer's disease in the U.S. and at least 11 million worldwide.
The trials, involving some 60 patients, were in the so-called phase I period of tests for the new drug. Phase II tests began earlier this month and will be conducted over a six-month period, Glasky said.
In another trial, AIT-082 limited brain damage in animals which had suffered a stroke.
Neotherapeutics last week said pre-clinical studies demonstrated that AIT-082 enhances cognitive function and memory in animals with neurological deficits.
The treatment works by stimulating genes in brain cells to produce proteins which help regenerate neurons.
Glasky said his company was the only one to be past the pre-clinical testing stage for such drug.
The company has a contract with a large European pharmaceutical company, which Glasky wouldn't name, to produce the treatment on a large scale should the Food and Drug Administration eventually give the go-ahead for its commercial use.
Every Patient Improved
Previous research to combat Alzheimer's had focused on providing patients with proteins which improved the performance of neurotransmitters, but which couldn't overcome the fact that the neurons themselves were dead.
Neotherapeutics also is in pre-clinical testing of small molecular compounds similar to AIT-082 which could combat severe dementia, depression and weight loss, Parkinson's disease, and migraines.
The tests on humans showed patients could take a dose of up to 4,000 milliliters without any side effects, and that the dosage probably would be between 50 to 500 milliliters, Glasky said. The phase II study will administer dosages for four weeks, after which patients will be under observation for four more weeks.
In the phase I trials, "every patient who received the drug showed more improvement than those who received the placebo," Glasky noted.
In the trials on animals who suffered a stroke, the drug limited damage caused when the brain doesn't receive enough oxygen during the stroke. In that instance, chemicals are formed which destroy neurons, a process known as neurotoxicity. By administering the drug orally or by injection under the skin, the process was prevented.
Neotherapeutics on May 14 reported a first quarter net loss of $2.5 million, or 46 cents a share, compared with a loss of $818,975, or 15 cents a share, a year earlier.
In April, the company said it received a $15 million equity-based credit line from an institutional investor to fund testing of AIT-082.
Glasky on Wednesday told Dow Jones Newswires that the financing was sufficient to meet all the company's needs through FDA approval of AIT-082 for commercial use.
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