More than three decades ago an El Paso brain scientist discovered, almost by accident, a drug that rolls back symptoms of Alzheimer’s.
But the drug has never made it onto pharmacy shelves. It was “born out of wedlock” the unplanned brainchild of Donald Moss who has launched one last push to get his drug to Alzheimer’s patients.
Without the backing of a prestigious government-funded research lab or big pharmaceutical company, Moss, a retired University of Texas at El Paso professor, has been unsuccessful in bringing the drug to market.
He has been thwarted by incompetent patent attorneys, management missteps and his own, self-inflicted setbacks.
But if Moss is successful, methanesulfonyl fluoride could be the most powerful Alzheimer’s drug brought to market since the disorder was first described by German scientist Alois Alzheimer more than a century ago.
The drug is not a cure; it does not stop the damage done to brain cells by Alzheimer’s – a disorder that gradually robs patients of their memories and personality. But clinical trials have shown methanesulfonyl fluoride – MSF for short – reduces and delays symptoms in Alzheimer’s patients.
“The drug allows you to function well, but underneath the brain is still deteriorating,” Moss says.
Most importantly MSF specifically targets the brain, making it three or five times more effective than drugs on the market now, Moss says.
Moss, who has a doctorate in physiological psychology from Colorado State University, has spent more than 30 years testing and perfecting the drug and battling to get it to market.
It began in 1982 when Moss read an article about Alzheimer’s disease. The article described the need for an Alzheimer’s drug and the unique characteristics it would have, which sparked Moss’s memory.
A decade earlier Moss and his brother, a graduate student at the time, had tinkered with some “bizarre chemicals” called Sulfonyl Fluorides that had the unique qualities described in the article. Moss developed the drug from that flash of inspiration.
Unfortunately, he made a presentation at a pharmacology meeting in Louisville, Ky., about his discovery, and his public disclosure of the idea, followed by mistakes made by a patent attorney, led to his losing the rights to the patent.
“My naïveté blew it,” Moss says.
Generally, drug companies aren’t willing to develop a drug without a patent, because they can’t recoup the high cost of bringing it to market. So for 20 years, Moss says, he didn’t have the money needed to bring the drug to market.
Funding came in small spurts from an El Paso-based foundation and the local Alzheimer’s association. Moss tested the drug on rats, monkeys and, later, on humans. In 1995, he conducted two clinical trials in Mexico that indicated the drug was effective.
Moss, a kind of friendly mad scientist, experimented on himself first, taking the drug at a higher dose than used in the clinical trials.
“I went home and I told my wife – a very longsuffering woman. I said, ‘I have to do this experiment on myself. Do you mind?’”
The drug works by slowing the breakdown of acetylcholine, which is essential for memory but is lost in Alzheimer’s patients. What makes Moss’s drug unique, he says, is it is selective for the brain, so it is more potent without the nasty side effects – nausea, vomiting and diarrhea.
“This is not apricot pits – this is not a green tea enema – this is absolutely solid science,” he says.
A partnership with a small Swiss biotech company a couple years ago led to FDA approval to test the drug in the United States and another successful human trial in Europe. In 2011, three years into an economic recession, the effort ultimately failed and Moss officially gave up.
He turned his attention to writing a book detailing his 30-year struggle. But a year later a chance encounter with an old classmate named James Summerton at a high school class reunion in 2012 led Moss to take up the project again.
Summerton owns a drug company and has the business and marketing smarts that Moss lacks. Together they founded Brain-Tools LLC., which aims to have the drug in pharmacies in three years, making it available to patients for $10 to $15 a week, according to Moss.
To do so, Moss says he and his partner need to raise $30 million – at least $20 million of that by the end of the year. They plan to do it by soliciting donations, applying for grants and through crowdfunding – a method for funding new ideas growing in popularity, which uses small amounts of capital from a large number of individuals to finance a business venture.
A bit of a rebel, Moss hopes to alter the way drugs are developed by bringing MSF to market, cheaply, under the Orphan Drug Act, using a novel business model.
The Orphan Drug Act was passed by Congress in 1983 to advance the development of treatments, often for rare medical conditions, that may not come to market because they’re not considered profitable.
Brain-Tools will produce the drug and market it.
“It’s going to come out cheap; it’s going to reduce health care insurance costs; it is going to reduce nursing home costs,” Moss says. “We are doing something that has never been done before.”
Moss recently published his book which details his more than 30-year struggle. It’s titled “Alzheimer’s: My Journey to a Next Generation Treatment” and is available at Amazon.com.
Email reporter Robert Gray at email@example.com or call (915) 534-4422 ext. 105.