Promising Results for Attention Drug
Irvine-based Cortex Pharmaceuticals Inc. announced positive results Monday from initial clinical trials for a drug to treat attention deficit hyperactivity disorder.
The test, conducted on 65 people across the U.S., showed that the drug significantly reduced key ADHD symptoms, said Lenard Adler of the New York University School of Medicine, who ran one of the trials.
Cortex immediately announced it would take the drug, one of a family of drugs called ampakines, into larger trials.
Shares in the tiny company jumped more than 32% to $3.04 after news of the trial was released, nearing a 52-week high.
Cortex has been working to develop ampakines almost since they were invented 15 years ago in the lab of Gary Lynch at UC Irvine, and the results by far made for the best day in the beleaguered company’s history.
Since it was founded in 1987, Cortex has had a new chief executive about every other year. The company has struggled financially and nearly went out of business more than once.
Current CEO Roger Stoll said the company had been in negotiations with pharmaceutical companies to license the compound, called CX717, even before the trial results were announced. He said eight or nine companies had expressed interest, with about half of those expressing new interest Monday.
Stoll said such a deal could eventually be worth several hundred million dollars to Cortex. The money would allow the company to develop ampakines for other disorders, which include Alzheimer’s disease, schizophrenia, Huntington’s and some forms of mental retardation.
Treatment of ADHD is a multibillion-dollar-a-year business. It affects an estimated 4% of the children in the United States. ADHD is thought to be caused by too much or too little production of certain chemicals, called neurotransmitters, in the brain. The main treatment to date has been the prescription of stimulants such as Ritalin and Adderall, which increase or inhibit production of one or more of the neurotransmitters.
More than 31 million prescriptions were written for the disorder last year, according to IMS Health Inc., a company that compiles pharmaceutical industry data. However, a federal Food and Drug Administration expert panel warned last month that the stimulants posed a risk for strokes and heart attacks and recommended that a strong warning accompany sale of the drugs. The FDA has not acted on that recommendation.
The Cortex drug is not a stimulant and theoretically would have no such risk. In fact, no significant side effects were uncovered in the trial.
Arvid Carlsson, a scientific advisor to Cortex who won a Nobel Prize for his studies of dopamine, one of the neurotransmitters involved in ADHD, said ampakines could be safer because they interact with different portions of the brain circuits that regulate behavior.
“It makes sense that if you have a very different target, some of the problems that are caused by these other drugs can be avoided,” he said. “It’s an exciting -- though preliminary -- finding.”
